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Enhancing Diabetes Management in Uganda: A Mobile based framework to Improving Patient Medication Adherence a Case Study of Mbarara Referral Hospital
Enhancing Diabetes Management in Uganda: A Mobile based framework to Improving Patient Medication Adherence a Case Study of Mbarara Referral Hospital
BY MATSIKO WINSTON
CONTACT: 0779346663
27/06/2024
Contents
1. INTRODUCTION ...................................................................................................................................................... 3
1.1. Background ......................................................................................................................................................3
1.2. Available Techniques for Diabetes Management: ...........................................................................................4
1.3. Limitations of Available Approaches: .............................................................................................................4
1.4. Justification ......................................................................................................................................................5
1.5. Problem Statement ...........................................................................................................................................6
1.6. General Objective ............................................................................................................................................ 7
1.7. Research Questions ..........................................................................................................................................7
1.8. Significance of the Study .................................................................................................................................8
2.0 LITERATURE REVIEW ......................................................................................................................................... 9
2.1. Diabetes Management Challenges ...................................................................................................................9
2.2. Mobile Health (mHealth) Interventions .......................................................................................................... 9
2.3.Existing Systems and Their Limitations ...........................................................................................................9
2.4 Paper-Based Record Keeping ...................................................................................................................9
2.5 Diabetes Digital Apps .............................................................................................................................10
2.6 Mobile-Based and Cloud-Based Systems ..............................................................................................11
2.7 Limitations Addressed by My Proposed System ....................................................................................11
METHODOLOGY ....................................................................................................................................................... 12
3.0. Overview ............................................................................................................................................................... 12
3.1 Research Design ........................................................................................................................................... 12
3.2 Study Setting ................................................................................................................................................. 13
3.2.1 Cross-sectional Study .......................................................................................................................... 13
3.3. Inclusion and Exclusion Criteria: ................................................................................................................. 14
Inclusion Criteria .......................................................................................................................................... 14
Exclusion Criteria ......................................................................................................................................... 14
3.4 Data Collection Methods: ...............................................................................................................................15
3.4.1 Questionnaires: .................................................................................................................................... 16
3.4.2 Interviews: ........................................................................................................................................... 16
3.4.4 Data Management ................................................................................................................................16
3.4.5 Data Entry and Storage: .......................................................................................................................16
3.4.6 Data Analysis: ......................................................................................................................................16
3.5 Data Flow Diagram (DFD) for Mobile Based-Diabetes Management Frame Work ..................................... 17
3.5.1 A mobile based framework development ............................................................................................18
3.5.9 Evaluation and Assessment ................................................................................................................. 20
3.6 Participants ............................................................................................................................................. 20
3.7 Community Engagement Plan ................................................................................................................ 20
3.8 Ethical Considerations ....................................................................................................................................22
Informed Consent: ........................................................................................................................................ 22
Protection of Vulnerable Populations: ..........................................................................................................22
3.9.COVID-19 Risk Management Plan: ...............................................................................................................23
COVID-19 Risk Management and Study Relevance ................................................................................... 25
3.9.1 Dissemination Plan ...................................................................................................................................... 25
3.9.2 Results and Discussion ................................................................................................................................ 26
Adherence Improvement .............................................................................................................................. 26
3.9.3 Patient Satisfaction .............................................................................................................................. 26
3.9.4 Challenges and Limitations ................................................................................................................. 26
Conclusion .................................................................................................................................................................... 27
Summary of Findings ........................................................................................................................................... 27
Implications .......................................................................................................................................................... 27
Recommendations ................................................................................................................................................ 27
References .................................................................................................................................................................... 28
Appendices ................................................................................................................................................................... 32
Appendix A ...........................................................................................................................................................32
Workplan ...................................................................................................................................................................... 32
Appendix B.Informed Consent for Patients ................................................................................................................. 34
Appendix C 1.Informed Consent For Health Care Providers ......................................................................................48
Appendix D.Budget Allocation: ........................................................................................................................... 62
Appendix E .Interview Guide for patient ............................................................................................................. 64
Appendix F. Questionnaire for Patients ............................................................................................................... 68
Appendix G Healthcare Provider Questionnaire .................................................................................................. 77
1. INTRODUCTION
This chapter provides an overview of the study's background, the challenges of diabetes
management, the available techniques, and their limitations. It also includes the justification for
the study, the problem statement, objectives, research questions, and the significance of the study.
1.1. Background
Diabetes Prevalence:
Globally, diabetes has reached epidemic proportions, with an estimated 463 million adults living
with the condition in 2019, a number projected to rise to 700 million by 2045 (Saeedi, P.,
Petersohn, I., Salpea, P., Malanda, B., Karuranga, S., Unwin,& Shaw,, 2019) . In Africa, the
prevalence of diabetes has been steadily increasing, attributed to rapid urbanization, adoption of
Western dietary patterns, and sedentary lifestyles (Pastakia, S. D., Pekny, C. R., & Manyara,
2019) . In Uganda specifically, the prevalence of diabetes has also been on the rise, with
estimates suggesting that over 1 million adults are affected by the condition (Mutungi, G., Edrisa,
M., & Kibaya, 2019).
1.2. Available Techniques for Diabetes Management:
Despite the effectiveness of various management strategies, several limitations persist. Lifestyle
modifications require sustained motivation and access to resources, which may be challenging
for individuals from low-income backgrounds or rural areas (Bennett et al., 2018).
Pharmacotherapy options may be limited by medication availability and affordability,
particularly in resource-constrained settings like many parts of Africa (Pastakia, S. D., Pekny, C.
R., & Manyara, 2019) . Furthermore, cultural beliefs and stigmas surrounding diabetes may
hinder treatment adherence and healthcare-seeking behavior (Beran, D., Yudkin, J. S., & de
Courten, 2019). Surgical interventions, while effective, are invasive and may not be feasible for
all patients due to cost, surgical risk, and availability of specialized centers (Rubino, F., Nathan,
D. M., Eckel, R. H., Schauer, P. R., Alberti, K. G., Zimmet, P. Z., ... & Del Prato, S, 2017).
1.4. Justification
Global Relevance: Diabetes is a prevalent chronic disease with global ramifications. As the
prevalence of diabetes continues to rise worldwide, effective management strategies are needed
across diverse healthcare settings. By studying and implementing evidence-based interventions
at Mbarara Referral Hospital, this proposal contributes to the broader understanding of diabetes
management and medication adherence (Saeedi, P., Petersohn, I., Salpea, P., Malanda, B.,
Karuranga, S., Unwin, N., ... & Shaw, J. E. , 2019).
Local Context and Impact: Mbarara Referral Hospital serves a diverse patient population,
including individuals from rural and low-income backgrounds. Understanding the specific
challenges faced by diabetic patients in this setting and tailoring interventions to address these
challenges can have a direct and meaningful impact on patient outcomes. By improving
medication adherence, this proposal aims to enhance the quality of diabetes care and reduce the
burden of disease in the local community (Mutungi, G., Edrisa, M., & Kibaya, R., 2019).
Contribution to Scientific Knowledge: Research conducted as part of this proposal will
contribute valuable insights to the field of diabetes management and medication adherence. By
investigating current approaches, designing and testing innovative interventions, and evaluating
their effectiveness, this study advances scientific knowledge and informs best practices in
diabetes care on both local and global scales (Beran, D., Yudkin, J. S., & de Courten, M., 2019).
This project proposal aims to address this critical issue by implementing evidence-based
interventions to enhance diabetes care and improve patient outcomes.
The primary objective of this study is to enhance Medication adherence among diabetic patients
receiving care at Mbarara Referral Hospital. To achieve this, the following Specific objectives
have been formulated.
To investigate the current approaches to enhance Medication adherence among diabetic patients
receiving Treatment.
To develop and test a mobile based framework that addresses the barriers to medication
adherence among diabetic patients at Mbarara Referral Hospital.
To evaluate the usability and acceptability of then developed framework through a mobile app.
What are the predominant current approaches employed globally to enhance medication
adherence among diabetic patients receiving treatment, and how effective are these
approaches in improving adherence rates?
How can a mobile-based framework be designed and implemented to specifically address
the identified barriers to medication adherence among diabetic patients at Mbarara
Referral Hospital, and what impact does the framework have on enhancing adherence in
this particular setting?
What is the level of usability and acceptability of the developed mobile app framework
designed to improve medication adherence among diabetic patients at Mbarara Referral
Hospital, as perceived by both healthcare providers and patients?
1.8. Significance of the Study
Improved medication adherence is essential for better diabetes management and reduced
complications.
The study has a potential to provide education and support to patients, addressing key barriers
to adherence.
The study contributes to the field of mobile health (mHealth) interventions for chronic disease
management
2.0 LITERATURE REVIEW
This chapter reviews existing literature on diabetes management challenges and the potential of
mobile health (mHealth) interventions to address these challenges. It includes an analysis of
current systems and their limitations, the evolution of digital apps for diabetes management, and
the rationale for the proposed system.
Diabetes management poses several challenges, including medication non-adherence, which can
lead to uncontrolled blood glucose levels and complications. Forgetfulness, treatment complexity,
and limited access to education are common reasons for non-adherence (Fisher et al., 2016).
Paper-Based Record Keeping, the current method for managing diabetic patient records relies on
traditional paper-based documentation (Fisher, L., et al. , 2016)
This system faces several challenges that impede effective diabetes management:
Accessibility and Retrieval: Retrieving patient information from paper files is time-consuming,
resulting in delays during emergencies or routine consultations.
Accuracy and Integrity: Manual entry of data leads to potential errors, impacting the accuracy of
patient records and treatment plans.
Storage Constraints: Physical storage requirements for paper documents pose challenges in
organization and space management.
Mobile health applications (apps) have rapidly evolved to assist individuals in managing diabetes.
These apps provide support for lifestyle interventions and medication adjustments based on
glucose-monitoring data. However, several challenges persist:
Regulatory Gaps:
Mobile health apps related to health and wellness are largely unregulated unless they meet the
definition of medical devices for therapeutic or diagnostic purposes. Insulin dose calculation
apps fall within the scope of regulation, while those providing health or nutritional information
are often unregulated (Fleming, G. A., Petrie, J. R., Bergenstal, R. M., Holl, R. W., Peters, A. L.,
& Heinemann, L. , 2020).
The available evidence on the safety and effectiveness of diabetes-related mobile health apps
remains limited. Regulatory authorities and organizations need to standardize app review
processes to ensure patient safety and clinical validity (Fleming, G. A., Petrie, J. R., Bergenstal,
R. M., Holl, R. W., Peters, A. L., & Heinemann, L. , 2020).
Many mobile software apps exist for diabetes management, but they often lack a theoretical
foundation and adherence to evidence-based guidelines (Fleming, G. A., Petrie, J. R., Bergenstal,
R. M., Holl, R. W., Peters, A. L., & Heinemann, L. , 2020) .These systems struggle with user-
friendliness and comprehensive educational resources. Some of the Existing mobile based frame
works include the Sugarmedown app (Fleming, G. A., Petrie, J. R., Bergenstal, R. M., Holl, R.
W., Peters, A. L., & Heinemann, L. , 2020).
3.0. Overview
This chapter outlines various steps involved in this research process, including research design,
study setting, sampling techniques, data collection, data analysis, pilot testing, and ethical
considerations.
The study will utilize a mixed-methods approach, combining quantitative analysis of medication
adherence data with qualitative assessment through patient and healthcare provider interviews
(Smith Patel, 2021).
The cross-sectional study will involve gathering medication adherence data from diabetic
patients receiving treatment. Quantitative analysis will be performed to assess the level of
adherence among the study population. Additionally, qualitative interviews will be conducted
with both patients and healthcare providers to gain insights into the factors influencing
medication adherence and to identify potential strategies for enhancement.
3.2 Study Setting
Participants:
The participants will include diabetic patients currently receiving treatment from Mbarara
referral Hospital. Eligible participants will be those diagnosed with diabetes and actively
prescribed medication for their condition.
Patients: A total of 10 diabetes patients will be selected using a random sampling technique to
ensure a representative sample of the target population. This method allows each patient an equal
chance of being chosen, thus minimizing selection bias and enhancing the generalization of the
study findings.
Healthcare Providers: A total of 6 healthcare providers will be selected using purposive sampling.
This technique is chosen to gather detailed qualitative data on the experiences and perspectives
of healthcare providers related to diabetes management and the use of the mobile-based
framework. Purposive sampling allows for the intentional selection of participants who have
specific knowledge or experience relevant to the research questions.
The sample size will be determined based on statistical considerations to ensure adequate
representation of the target population and to achieve appropriate statistical power for the study.
The calculation will consider factors such as the anticipated effect size, level of significance, and
potential dropout rates. To ensure robustness, Cochran’s formula for sample size calculation in
observational studies will be used.
Cochran's Formula:
( Z ^ 2) p (1 p )
n
( e ^ 2)
Explanation of Parameters:
Z-value (Z): The Z-value corresponds to the desired confidence level. For a 95% confidence
interval, the Z-value is 1.96.
Estimated Proportion (p): The proportion is an estimate of the attribute of interest within the
population. If there is no prior information, 0.5 is used as it maximizes the sample size and
ensures a conservative estimate.
Margin of Error (e): This represents the desired precision of the estimate. A margin of error of
0.05 is commonly used in social science research to balance precision and feasibility.
By applying these parameters, the sample size calculation will ensure that the study has
sufficient power to detect significant effects and provide reliable and valid results. This careful
determination of sample size will contribute to the overall rigor and credibility of the research
findings.
Inclusion Criteria
Exclusion Criteria
Those not prescribed on diabetes medication.
Ethical Guidelines: Ethical guidelines for research involving minors require additional consent
procedures and protections, adding complexity to the study.
Behavioral and Psychological Factors: Medication adherence in minors involves complex factors
such as parental involvement and peer influences, which are outside the study's focus.
Data will be collected using structured questionnaires, interviews, and focus group discussions.
All data collection instruments, including questionnaires and interview guides, will be provided
in both English and the local language (Luganda) to ensure that all participants fully understand
the questions and instructions. I will use google online translators to assist participants during
the data collection process to address any language barriers and to ensure accurate and reliable
responses.
3.4.2 Questionnaires:
3.4.3 Interviews:
Focus group discussions will be held with patients and healthcare providers to facilitate a deeper
understanding of the usability and effectiveness of the mobile-based framework.
Data will be entered into an electronic database and backed up regularly to prevent data loss.
Quantitative data will be analyzed using descriptive and inferential statistics. Qualitative data
will be analyzed thematically to identify key themes and patterns.
Objective 2: To develop and test a mobile based framework that addresses the barriers to
medication adherence among diabetic patients at Mbarara Referral Hospital.
Objective 2 will involve developing and testing a mobile-based framework to address barriers to
medication adherence among diabetic patients at Mbarara Referral Hospital, several UML
diagrams such as the Data Flow Diagram will be useful for planning and illustrating the system
architecture and functionality.
3.5 Data Flow Diagram (DFD) for Mobile Based-Diabetes Management Frame Work
The data flow diagram illustrate the flow of data within the mobile-based framework, depicting
how information will move between various processes, data stores, and external entities.
Processes will represent the different functionalities or operations performed by the system, such
as data input, processing, and output. Data stores will represent the repositories where data is
stored or retrieved, while external entities will depict sources or destinations of data outside the
system (Wikipedia, 2024).
Fig1. Data Flow Diagram (DFD)-Level 0 for Mobile Based-Diabetes Management Frame
Work
External Entities:
Data input:Patients input medication adherence data into the mobile app
Data storage: the app stores the input data in a secure database
Data processing: the app processes the data to identify adherence patterns and potential
issues
Feedback loop:processed data is analyzed and shared with healthcare providers for further
action.
Report Generation: Generates reports for both patients and healthcare providers
Data stores:
The above data flow diagram will serve as essential planning and design tools, guiding the
development and testing process of the proposed solution to address medication adherence
barriers among diabetic patients at Mbarara Referral Hospital.
The mobile app will include features such as medication reminders, comprehensive educational
resources, blood glucose tracking, and seamless communication channels with healthcare
providers.
3.5.3 User Interface Design
The app’s user interface will be designed to be intuitive and user-friendly, catering to the needs
of diabetic patients of varying ages and technical skills.
The app will be developed in the Android platform using industry-standard development tools
and cross platform versions of the app will be designed
The app will undergo rigorous testing to ensure functionality, usability, and security. User
feedback will be incorporated into iterative development.
The app will be deployed on app stores, and patients will receive guidance on downloading and
using it.
Patients will be provided with training sessions or materials to ensure they can effectively use the
app.
Stringent security measures will be implemented to protect patient data and ensure compliance
with privacy regulations.
3.5.9 Evaluation and Assessment
3.5.9.1Adherence Monitoring
Medication adherence will be monitored before and after app implementation to assess its impact.
Patients will provide feedback on their experiences with the app, focusing on usability and its
role in improving adherence.
Healthcare providers will be interviewed to gather insights into the app’s impact on patient care
and its
potential benefits.
3.6 Participants
Participants:
Participants will include diabetic patients currently receiving treatment at Mbarara Referral
Hospital who consent to use the mobile app for medication management. Additionally,
healthcare providers involved in diabetes care, including doctors, nurses, and pharmacists, will
be interviewed for their feedback.
The community engagement plan is designed to ensure the relevance, acceptability, and success
of the research study by actively involving stakeholders at various levels. This plan fosters
collaboration, transparency, and mutual understanding.
Community Leaders and Advocacy Groups: Involved in raising awareness about the
study and advocating for participation. Their role is crucial in garnering community
support and ensuring cultural sensitivity.
Healthcare Providers: Collaborate closely in implementing interventions and providing
feedback on their feasibility. Their insights and expertise are vital for the practical aspects
of the research.
Patients and Families: Actively engaged through educational workshops, support groups,
and feedback mechanisms. Their participation ensures the study addresses their needs and
concerns.
Community workshops, seminars, and educational sessions will be organized to raise awareness
about diabetes management and the importance of medication adherence. These activities will be
conducted in collaboration with local community organizations, healthcare facilities, and media
outlets to reach a wider audience.
A community advisory board comprising representatives from diverse stakeholder groups will be
established to provide ongoing input and guidance throughout the research process.
Feedback Mechanisms: Suggestion boxes, hotlines, and online surveys will be
implemented to gather input from community members.
Regular Updates: Regular meetings and updates will be provided to ensure transparent
communication and collaboration.
Informed Consent:
All participants will be provided with detailed information about the study, including its purpose,
procedures, risks, and benefits. Informed consent will be obtained from each participant before
they are enrolled in the study.
Institutionalized individuals are considered vulnerable in this study for several reasons:
Limited Mobility: These individuals often have restricted mobility, hindering their ability to
access diabetes management resources, participate in physical activities, and attend regular
medical appointments.
Potential Lack of Immediate Family Support: Institutionalized individuals may have less
frequent contact with family and friends, affecting their mental well-being and adherence to
diabetes management plans.
Higher Risk of Comorbidity Conditions: The presence of multiple chronic conditions can
complicate diabetes management, making it more challenging to maintain optimal blood glucose
levels and adhere to treatment regimens.
Psycho-social Factors: Feelings of isolation, depression, or anxiety due to their living situation
can negatively impact their motivation and ability to manage diabetes effectively.
Dependence on Institutional Policies: The policies and routines of the institution can
significantly influence their diabetes management practices.
Informed Consent: Ensuring that all participants are fully informed about the study, its purpose,
procedures, risks, and benefits, and that their participation is voluntary.
Additional Support: Providing additional educational resources and support tailored to the needs
of institutionalized individuals to enhance their understanding and management of diabetes.
Institutional Collaboration: Working closely with the institutions to ensure that the study does
not disrupt routine care and that participants receive the necessary support throughout the study
period.
To ensure the safety of participants and research staff, the following measures will be
implemented in relation to the study on diabetes management:
Personal Protective Equipment (PPE): All study personnel will use PPE, including masks, gloves,
and face shields, as appropriate during in-person interactions.
Hand Hygiene: Regular hand washing and the use of hand sanitizers will be enforced for both
participants and study personnel.
Physical Distancing: Physical distancing measures will be maintained during in-person
interactions, and contact will be minimized as much as possible.
Symptom Screening: Regular screening for COVID-19 symptoms will be conducted for both
participants and study personnel. Individuals exhibiting symptoms or having been exposed to a
confirmed case will follow isolation protocols and seek testing.
Testing: Regular COVID-19 testing will be conducted in line with public health guidelines,
especially for study personnel and participants involved in face-to-face data collection.
Remote Data Collection: Wherever possible, data collection and participant interactions will be
conducted remotely via phone or video calls to minimize physical contact.
Scheduled Appointments: In cases where in-person visits are necessary, appointments will be
scheduled to avoid overcrowding, and areas will be sanitized between visits.
Vaccination:
Clear Communication: Clear communication regarding COVID-19 risks and safety measures
will be provided to all participants. Support will be available to address any concerns or
questions related to COVID-19.
Given the COVID-19 pandemic, this study is particularly relevant as it explores the potential of
m Health to support diabetes management remotely, thus reducing the need for frequent hospital
visits and minimizing the risk of exposure to COVID-19 for both patients and healthcare
providers. The mobile-based framework will enable continuous monitoring and support, which is
critical during the pandemic when healthcare resources are strained,and access to in-person care
is limited. This integration of mHealth within the study not only aims to improve diabetes
management outcomes but also contributes to safer healthcare practices during and beyond the
COVID-19 pandemic.
The dissemination of research findings is crucial to maximize impact and benefit stakeholders
involved in diabetes management. Targeted audiences include healthcare professionals,
community leaders, and patients along with their families.
To ensure broad dissemination, findings will be published in esteemed medical journals and
presented at prominent conferences, facilitating knowledge exchange and academic engagement.
Additionally, local workshops, seminars, and health education sessions will be conducted to
directly engage healthcare providers and community leaders, fostering understanding and
implementation of effective diabetes management strategies.
Policy briefs tailored for policymakers and collaborative efforts with local health authorities will
advocate for integrating research outcomes into healthcare policies and practices. Community
partnerships with organizations and media outlets will further amplify awareness and
understanding of diabetes care among the public.
A dedicated website will serve as a central hub for disseminating study updates, resources, and
educational materials. Social media platforms will be utilized to enhance outreach and
engagement with diverse audiences.
Evaluation of dissemination efforts will include tracking citation metrics, assessing workshop
participation, and monitoring policy adoption rates. Stakeholder feedback will be gathered
through surveys and focus groups to continuously refine dissemination strategies and ensure
relevance.
Financial resources will be allocated for publication fees, workshop logistics, and maintaining
digital platforms. Dedicated personnel will oversee and coordinate dissemination activities,
ensuring effective implementation and sustained impact beyond the study duration.
Immediate actions upon study completion will include manuscript submission and presentation
preparations, followed by ongoing dissemination activities to maintain momentum and maximize
the study's influence on diabetes management practices.
Adherence Improvement
Results will be presented, showing changes in medication adherence rates before and after app
implementation
Patient feedback will be analyzed to determine overall satisfaction with the app.
Any challenges faced during app development and implementation, as well as limitations of the
study, will be discussed.
Conclusion
Summary of Findings
The study’s findings will be summarized, highlighting the app’s impact on medication adherence
and patient
outcomes.
Implications
Implications for diabetes management and the use of mHealth interventions will be discussed.
Recommendations
Recommendations for further research and potential improvements to the app will be provided.
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General Internal Medicine, 33(2), 211-218. Effects of limited English proficiency and
physician language on health care comprehension. Journal of General Internal Medicine,
33(2), 211-218.
World Health Organization (WHO). (2016). Global Report on Diabetes. Retrieved from
https://www.who.int/publications/i/item/9789241565257
World Health Organization. (2019). Global report on diabetes. Global report on diabetes. World
Health Organization.
World Health Organization. (2019). Global report on diabetes. World Health Organization.
Appendices
Appendix A
Workplan
Months March July 2024 Aug Sept Oct 2024
– June 2024 2024
2024
Aim: To develop and implement a mobile-based framework that addresses the
barriers to medication adherence among diabetic patients at Mbarara Referral
Hospital
Determine patient needs ███
for medication
adherence
Interview patients and ███
healthcare providers
Design user-friendly ███
interface for patients and
providers
Begin user testing with ███
healthcare providers to
track patient progress
This document outlines the research study and expectations for potential participants. It should
be written in layman terms and typed on MUST-REC letterhead.
Instructions
1. The wording of this document should be directed to the potential participant not MUST-
REC.
2. If a technical term must be used, then define it the first time it is used and any acronyms
or abbreviations used should be spelled out the first time they are used.
3. All the sections of this document must be completed without any editing or deletions.
4. Please use a typing font that is easily distinguishable from the questions of this form.
Preferably the font size should be 12.
Study title – This should be the same as on all other documents related to the study.
Matsiko Winston
Introduction
This study aims to address these challenges by developing and evaluating a mobile-based
framework designed to improve medication adherence among diabetic patients at Mbarara
Referral Hospital. By leveraging mobile technology, the study seeks to enhance patient
education, support, and engagement, thereby optimizing diabetes management outcomes in
this resource-constrained setting.
Purpose of the research project
This study involves research aimed at improving medication adherence among diabetic patients
at Mbarara Referral Hospital through the use of a mobile-based framework. We aim to
understand the challenges faced by patients in managing diabetes and to develop a technological
solution to support better health outcomes.
Research Involvement: This study is part of a research project designed to evaluate the
effectiveness of a mobile app intervention in enhancing medication adherence and overall
diabetes management.
Estimated Number of Participants: Approximately 10 diabetic patients receiving care
at Mbarara Referral Hospital will be invited to participate in this study.
Purpose: The main purposes of this research are:
o To investigate current approaches to enhancing medication adherence among
diabetic patients.
o To develop and test a mobile-based framework that addresses the barriers to
medication adherence.
o To evaluate the usability and acceptability of the developed mobile app
framework.
Duration of Participation: Your participation in this study is expected to last for
approximately 6 months. During this period, you will be involved in several activities
including initial assessments, using the mobile app, and participating in follow-up
assessments and feedback sessions.
Your involvement in this research will contribute to a better understanding of how technology
can be leveraged to support diabetes management, potentially benefiting not only the participants
but also the wider community and future healthcare practices.
You have been selected to participate in this study because you are a diabetic patient receiving
care at Mbarara Referral Hospital. Your participation is crucial to understanding the challenges
you face in managing diabetes and assessing the effectiveness of a mobile-based intervention
designed to improve medication adherence.
Your insights and experiences will provide valuable information on the usability and
acceptability of the mobile app framework. By participating, you contribute directly to efforts
aimed at enhancing diabetes management and ultimately improving health outcomes for diabetic
patients at Mbarara Referral Hospital and similar healthcare settings.
Procedures
Participants in this study will be involved in several procedures aimed at evaluating the
effectiveness of a mobile-based framework to improve medication adherence among diabetic
patients at Mbarara Referral Hospital. The procedures include:
The study involves experimental procedures related to the use of the mobile app intervention.
Participants will not undergo clinical procedures beyond routine medical assessments already
conducted as part of their diabetes care.
Duration of Storage:
I consent to participate in this study understanding that the procedures involve the use of a
mobile app intervention to improve medication adherence. I acknowledge that no biological
specimens will be collected or stored as part of this study. I understand that my participation is
voluntary, and I may withdraw at any time without consequence.
Risks or Discomforts:
Participation in this study involves minimal risks and discomforts, which are outlined below:
1.Physical Risks: There are no direct physical risks associated with using the mobile app
or participating in assessments. However, participants may experience mild discomfort
related to answering questions about their health or diabetes management.
2.Psychological Risks: Participants may experience minor psychological discomfort
discussing their health status or adherence behaviors. Privacy and confidentiality will be
strictly maintained to minimize any potential embarrassment or anxiety.
Confidentiality: All personal and health information will be kept confidential and stored
securely.
Informed Consent: Participants will be fully informed about the study procedures, risks,
and benefits before providing consent.
Voluntary Participation: Participation is voluntary, and participants can withdraw from
the study at any time without consequences.
Support: Participants will have access to support from the research team for any
questions or concerns that may arise during the study.
The risks associated with this study are minimal compared to the potential benefits of better
managing diabetes and contributing to scientific knowledge. Participants' safety and well-being
are paramount, and every effort will be made to ensure a positive and supportive study
experience.
Benefits
Personal Benefits:
Other Benefits:
No Costs to Participants: There are no costs associated with participating in this study. Any
travel expenses incurred for study-related visits to Mbarara Referral Hospital will be reimbursed.
The confidentiality of your personal and health information is of utmost importance. The
following measures will be taken to ensure that your data is protected:
1. All personal and health information collected during the study will be stored
securely in password-protected electronic databases or locked physical files
accessible only to the research team.
2. Data will be anonymized, and each participant will be assigned a unique
identification number to protect their identity.
Confidentiality of Records:
1. This study will not collect or use tape recordings, photographs, movies, or
videotapes. If such data were to be collected in future studies, you would be
informed, and explicit consent would be sought for their use and retention period.
Instructional Use:
By participating in this study, you are assured that every effort will be made to maintain the
confidentiality of your records and protect your privacy.
Ensuring the privacy of participants during data collection is a top priority. The following
measures will be taken to protect your privacy:
Private and Confidential Setting:
1. For any remote or digital data collection (e.g., surveys, interviews via phone or
video call), secure and encrypted communication channels will be used to protect
your privacy.
2. Participants will be instructed on how to use these secure channels to minimize
the risk of unauthorized access to their information.
1. Personal identifiers will be removed from the data collected to ensure that your
identity is protected.
2. Data will be anonymized by assigning unique codes to each participant, which
will be used in place of names or other identifying information.
Minimizing Intrusiveness:
1. Only information that is necessary for the study will be collected to minimize the
intrusion into your personal life.
2. Questions and assessments will be designed to be respectful and sensitive to your
privacy.
Trained Research Staff:
1. You will be fully informed about the data collection process and the measures in
place to protect your privacy before you give consent to participate.
2. Participation is voluntary, and you may choose to skip any questions or withdraw
from the study at any time without any consequences.
By implementing these measures, we aim to ensure that your privacy is protected throughout
your participation in the study.
Participation in this study is entirely voluntary. You have the right to refuse to participate or to
withdraw from the study at any time without any penalty or loss of benefits to which you are
otherwise entitled. Your decision to participate or not will not affect your current or future
medical care at Mbarara Referral Hospital or your relationship with the healthcare providers and
research staff.
If you choose to withdraw from the study, you can do so at any point by informing the research
team. Any data collected from you up to the point of withdrawal will be retained for analysis
unless you request otherwise.
Your autonomy and decision-making power are respected throughout the study, and you are
encouraged to ask questions and seek clarification at any stage.
What Happens if You Leave the Study?
You have the right to discontinue your participation in this study at any time without penalty or
loss of benefits to which you are otherwise entitled. If you decide to leave the study:
1. Your decision to withdraw from the study will not result in any penalty or loss of
benefits. Your current and future medical care at Mbarara Referral Hospital will
not be affected in any way.
2. You will continue to receive the same standard of care and support from your
healthcare providers.
Data Handling:
1. If you choose to withdraw, any data collected from you up to that point will still
be used for the study unless you request that it be destroyed.
2. You may specify if you want your data to be excluded from the study analysis at
the time of withdrawal.
Communication:
Voluntary Participation:
1. Your participation in this study is entirely voluntary. You are free to make
decisions about your involvement without any pressure or influence from the
research team.We appreciate your contribution to this research, and your decision
to withdraw will be respected fully.
Chairman, MUST-REC
Tel: 0485433795/0773573372
Matsiko Winston
Researcher
Tel:077936663
You have been informed about this study’s purpose, procedures, possible benefits and
risks
You have been given the chance to ask questions before you sign
You have voluntarily agreed to be in this study
__________________ __________________ ____
________
Name of adult participant Signature/Thumbprint of participant/ Date
Parent/Guardian/Next of Kin
This document outlines the research study and expectations for potential participants. It should
be written in layman terms and typed on MUST-REC letterhead.
Instructions
5. The wording of this document should be directed to the potential participant not MUST-
REC.
6. If a technical term must be used, then define it the first time it is used and any acronyms
or abbreviations used should be spelled out the first time they are used.
7. All the sections of this document must be completed without any editing or deletions.
8. Please use a typing font that is easily distinguishable from the questions of this form.
Preferably the font size should be 12.
Study title – This should be the same as on all other documents related to the study.
Matsiko Winston
Introduction
This study aims to address these challenges by developing and evaluating a mobile-based
framework designed to improve medication adherence among diabetic patients at Mbarara
Referral Hospital. By leveraging mobile technology, the study seeks to enhance patient
education, support, and engagement, thereby optimizing diabetes management outcomes in
this resource-constrained setting.
Purpose of the research project
This study involves research aimed at improving medication adherence among diabetic patients
at Mbarara Referral Hospital through the use of a mobile-based framework. We aim to
understand the challenges faced by patients in managing diabetes and to develop a technological
solution to support better health outcomes.
Research Involvement: This study is part of a research project designed to evaluate the
effectiveness of a mobile app intervention in enhancing medication adherence and overall
diabetes management.
Estimated Number of Participants: Approximately 10 diabetic patients receiving care
at Mbarara Referral Hospital will be invited to participate in this study.
Purpose: The main purposes of this research are:
o To investigate current approaches to enhancing medication adherence among
diabetic patients.
o To develop and test a mobile-based framework that addresses the barriers to
medication adherence.
o To evaluate the usability and acceptability of the developed mobile app
framework.
Duration of Participation: Your participation in this study is expected to last for
approximately 6 months. During this period, you will be involved in several activities
including initial assessments, using the mobile app, and participating in follow-up
assessments and feedback sessions.
Your involvement in this research will contribute to a better understanding of how technology
can be leveraged to support diabetes management, potentially benefiting not only the participants
but also the wider community and future healthcare practices.
Purpose of the Research Project This study involves research aimed at improving medication
adherence among diabetic patients at Mbarara Referral Hospital through the use of a mobile-
based framework. We aim to understand the challenges faced by patients in managing diabetes
and to develop a technological solution to support better health outcomes.
Research Involvement: This study is part of a research project designed to evaluate the
effectiveness of a mobile app intervention in enhancing medication adherence and overall
diabetes management.
Estimated Number of Participants: Approximately 10 diabetic patients and 5
healthcare providers involved in diabetes care at Mbarara Referral Hospital will be
invited to participate in this study.
Purpose: The main purposes of this research are:
o To investigate current approaches to enhancing medication adherence among
diabetic patients.
o To develop and test a mobile-based framework that addresses the barriers to
medication adherence.
o To evaluate the usability and acceptability of the developed mobile app
framework.
Duration of Participation: Your participation in this study is expected to last for
approximately 6 months. During this period, you will be involved in several activities,
including initial assessments, using the mobile app, and participating in follow-up
assessments and feedback sessions.
Your involvement in this research will contribute to a better understanding of how technology
can be leveraged to support diabetes management, potentially benefiting not only the participants
but also the wider community and future healthcare practices.
Why You Are Being Asked to Participate You have been selected to participate in this study
because you are a healthcare provider involved in diabetes care at Mbarara Referral Hospital.
Your participation is crucial to understanding the challenges faced in diabetes management and
assessing the effectiveness of a mobile-based intervention designed to improve medication
adherence.
Your insights and experiences will provide valuable information on the usability and
acceptability of the mobile app framework. By participating, you contribute directly to efforts
aimed at enhancing diabetes management and ultimately improving health outcomes for diabetic
patients at Mbarara Referral Hospital and similar healthcare settings.
Procedures Participants in this study will be involved in several procedures aimed at evaluating
the effectiveness of a mobile-based framework to improve medication adherence among diabetic
patients at Mbarara Referral Hospital. The procedures include:
Experimental and Clinical Procedures: The study involves experimental procedures related to
the use of the mobile app intervention. Participants will not undergo clinical procedures beyond
routine medical assessments already conducted as part of their diabetes care.
Consent for Participation and Specimen Storage: I consent to participate in this study
understanding that the procedures involve the use of a mobile app intervention to improve
medication adherence. I acknowledge that no biological specimens will be collected or stored as
part of this study. I understand that my participation is voluntary, and I may withdraw at any
time without consequence.
Risks or Discomforts: Participation in this study involves minimal risks and discomforts, which
are outlined below:
1. Physical Risks: There are no direct physical risks associated with using the mobile app
or participating in assessments. However, participants may experience mild discomfort
related to answering questions about their health or diabetes management.
2. Psychological Risks: Participants may experience minor psychological discomfort
discussing their health status or adherence behaviors. Privacy and confidentiality will be
strictly maintained to minimize any potential embarrassment or anxiety.
3. Social Risks: There is a minimal risk of social discomfort if participants disclose
personal health information during interviews or surveys. Confidentiality measures will
be in place to protect participant privacy.
4. Legal Risks: There are no legal risks anticipated in this study.
Confidentiality: All personal and health information will be kept confidential and stored
securely.
Informed Consent: Participants will be fully informed about the study procedures, risks,
and benefits before providing consent.
Voluntary Participation: Participation is voluntary, and participants can withdraw from
the study at any time without consequences.
Support: Participants will have access to support from the research team for any
questions or concerns that may arise during the study.
Risks vs. Anticipated Benefits: The anticipated benefits of this study include:
The risks associated with this study are minimal compared to the potential benefits of better
managing diabetes and contributing to scientific knowledge. Participants' safety and well-being
are paramount, and every effort will be made to ensure a positive and supportive study
experience.
Personal Benefits:
Other Benefits:
Note on Personal Benefit: While individual benefits cannot be guaranteed, participation in the
study offers an opportunity to contribute to improving diabetes care and advancing healthcare
practices.
Incentives or Rewards for Participating No Costs to Participants: There are no costs
associated with participating in this study. Any travel expenses incurred for study-related visits
to Mbarara Referral Hospital will be reimbursed.
Protecting Data Confidentiality The confidentiality of your personal and health information is
of utmost importance. The following measures will be taken to ensure that your data is protected:
1. All personal and health information collected during the study will be stored securely in
password-protected electronic databases or locked physical files accessible only to the
research team.
2. Data will be anonymized, and each participant will be assigned a unique identification
number to protect their identity.
Confidentiality of Records:
1. Information identifying participants will be kept confidential and will not be disclosed to
anyone outside the research team except as required by law.
2. Any published results from this study will not include information that can identify
individual participants.
1. Data collected in the form of digital records, such as responses from the mobile app,
interviews, or surveys, will be retained for a period of five years after the completion of
the study.
2. After this period, all identifiable data will be securely destroyed to ensure continued
confidentiality.
Instructional Use:
1. No multimedia data will be shown or played for instructional purposes without your
explicit consent. Any instructional use of data collected from this study will be fully
disclosed, and additional consent will be obtained.
By participating in this study, you are assured that every effort will be made to maintain the
confidentiality of your records and protect your privacy.
Protecting Subject Privacy During Data Collection Ensuring the privacy of participants
during data collection is a top priority. The following measures will be taken to protect your
privacy:
1. All interviews and assessments will be conducted in a private setting to ensure that your
conversations and responses are not overheard by others.
2. If the data collection occurs in a clinic or hospital, a private room or designated
confidential area will be used.
1. For any remote or digital data collection (e.g., surveys, interviews via phone or video
call), secure and encrypted communication channels will be used to protect your privacy.
2. Participants will be instructed on how to use these secure channels to minimize the risk of
unauthorized access to their information.
Minimizing Intrusiveness:
1. Only information that is necessary for the study will be collected to minimize the
intrusion into your personal life.
2. Questions and assessments will be designed to be respectful and sensitive to your privacy.
1. You will be fully informed about the data collection process and the measures in place to
protect your privacy before you give consent to participate.
2. Participation is voluntary, and you may choose to skip any questions or withdraw from
the study at any time without any consequences.
By implementing these measures, we aim to ensure that your privacy is protected throughout
your participation in the study.
Right to Refuse or Withdraw Participation in this study is entirely voluntary. You have the
right to refuse to participate or to withdraw from the study at any time without any penalty or
loss of benefits to which you are otherwise entitled. Your decision to participate or not will not
affect your current or future medical care at Mbarara Referral Hospital or your relationship with
the healthcare providers and research staff.
If you choose to withdraw from the study, you can do so at any point by informing the research
team. Any data collected from you up to the point of withdrawal will be retained for analysis
unless you request otherwise.
Your autonomy and decision-making power are respected throughout the study, and you are
encouraged to ask questions and seek clarification at any stage.
What Happens if You Leave the Study? You have the right to discontinue your participation in
this study at any time without penalty or loss of benefits to which you are otherwise entitled. If
you decide to leave the study:
1. Your decision to withdraw from the study will not result in any penalty or loss of benefits.
Your current and future medical care at Mbarara Referral Hospital will not be affected in
any way.
2. You will continue to receive the same standard of care and support from your healthcare
providers.
Data Handling:
1. If you choose to withdraw, any data collected from you up to that point will still be used
for the study unless you request that it be destroyed.
2. You may specify if you want your data to be excluded from the study analysis at the time
of withdrawal.
Communication:
1. You are encouraged to communicate your decision to withdraw to the research team.
They will assist you and answer any questions you may have regarding the withdrawal
process.
Voluntary Participation:
1. Your participation in this study is entirely voluntary. You are free to make decisions
about your involvement without any pressure or influence from the research team.
We appreciate your contribution to this research, and your decision to withdraw will be respected
fully.
Chairman, MUST-REC
Tel: 0485433795/0773573372
Matsiko Winston
Researcher
Tel: 077936663
You have been informed about this study’s purpose, procedures, possible benefits and
risks
You have been given the chance to ask questions before you sign
You have voluntarily agreed to be in this study
__________________ __________________ ____
________
Name of adult participant Signature/Thumbprint of participant/ Date
Parent/Guardian/Next of Kin
__________________ __________________ ____
________
Name of person obtaining consent Signature Date
BY MATSIKO WINSTON
CONTACT: 0779346663
Daily-work - - 700,000
Expenses
Printing of - - 500,000
Interview
Guides
2 Personnel Research - - -
Assistant
Stipends
3 Software Mobile - - -
Development application
development
Transcription 200,000
Services
Other - - 636,000
miscellaneous
expenses
total 4,636,000
ugx
Appendix E .Interview Guide for patient
BY MATSIKO WINSTON
CONTACT: 0779346663
Introduction:
Thank you for agreeing to participate in this interview. The purpose of this interview is to gather
insights into your experiences with diabetes management and medication adherence. Your input
will help us understand the challenges you face and identify potential strategies for improvement.
Your participation is voluntary, and you have the right to withdraw at any time. Your responses
will be kept confidential.
Personal Background:
Can you briefly tell me about your experience living with diabetes?
How long have you been diagnosed with diabetes, and how has it impacted your life?
Could you describe your current diabetes management routine, including medication adherence?
Medication Adherence:
What factors influence your decision to adhere to your prescribed medication regimen?
Have you ever experienced difficulties in adhering to your medication schedule? If so, what were
they?
Are there any specific challenges you face in obtaining or refilling your medications?
Have you ever missed taking your medication? If yes, what do you think contributed to it?
How do you track your medication adherence? Do you use any tools or apps for this purpose?
Barriers to Adherence:
11. Can you identify any barriers or challenges that make it difficult for you to adhere to your
medication regimen?
How do factors such as lifestyle, work, or family responsibilities affect your ability to manage
your diabetes and adhere to medications?
Have you experienced any side effects from your medications that have affected your adherence?
Are there any cultural or social factors that influence your medication adherence?
15. What kind of support do you receive from healthcare providers or family members in
managing your diabetes and adhering to medications?
Have you participated in any diabetes education programs or support groups? If yes, how have
they helped you?
Do you have access to educational materials or resources that provide information about diabetes
management and medication adherence?
18. How do you perceive the role of technology, such as mobile apps, in managing diabetes and
improving medication adherence?
In your opinion, what improvements could be made to current diabetes management practices to
better support medication adherence?
Do you have any suggestions for healthcare providers or policymakers to enhance diabetes care
and medication adherence support?
Conclusion:
21. Is there anything else you would like to share about your experiences with diabetes
management and medication adherence?
Thank you for your valuable insights and participation in this interview. Your feedback will
contribute to improving diabetes care for individuals like yourself.
Appendix F. Questionnaire for Patients
BY MATSIKO WINSTON
CONTACT: 0779346663
Study Title:
☐ Under 18
☐ 18-24
☐ 25-34
☐35-44
☐ 45-54
☐55-64
☐ 65 and above
☐ Male
☐ Female
☐ Primary education
☐Secondary education
☐ Employed full-time
☐Employed part-time
☐Self-employed
☐ Unemployed
☐ Retired
☐Student
☐Single
☐ Married
☐ Divorced
☐ Widowed
☐1-2 years
☐ 3-5 years
☐6-10 years
☐ Daily
☐Weekly
☐ Monthly
☐ Rarely/Never
☐Always
☐Sometimes
☐ Rarely
☐ Never
☐ Yes
☐ No
If yes, what are the reasons for missing your medication? (Check all that apply)
☐ Forgetfulness
☐Side effects
☐ Cost of medication
10. Do you follow a specific diet plan for managing your diabetes?
☐Yes
☐No
☐Yes
☐No
☐Daily
☐ Weekly
☐Monthly
☐ Rarely/Never
☐Very comfortable
☐ Comfortable
☐Neutral
☐Uncomfortable
☐ Very uncomfortable
15.Do you currently use any health-related mobile apps?
☐ Yes
☐ No
16. How easy was it to use the mobile app provided in this study?
☐ Very easy
☐ Easy
☐ Neutral
☐ Difficult
☐Very difficult
17. How helpful was the mobile app in reminding you to take your medication?
☐ Very helpful
☐ Helpful
☐Neutral
☐ Unhelpful
☐ Very unhelpful
18. How useful were the educational resources provided in the mobile app?
☐ Very useful
☐ Useful
☐ Neutral
☐ Useless
☐ Very useless
19. How effective was the mobile app in helping you manage your diabetes?
☐ Very effective
☐Effective
☐ Neutral
☐ Ineffective
☐ Very ineffective
19. Did you encounter any issues or challenges while using the mobile app?
☐Yes
☐No
21.How satisfied are you with your overall experience using the mobile app?
☐Very satisfied
☐ Satisfied
☐Neutral
☐ Dissatisfied
☐ Very dissatisfied
22. What did you like most about the mobile app?
_______________________________________________________________
23. What did you like least about the mobile app?
_______________________________________________________________
24. Do you have any suggestions for improving the mobile app?
_______________________________________________________________
25. Would you recommend this mobile app to other diabetic patients?
[ ] Yes
[ ] No
26. Any additional comments or feedback:
______________________________________________________________
Please ensure that your answers are as honest and accurate as possible. Your feedback is
invaluable in helping us improve diabetes management through mobile technology. If you have
any questions or need assistance, please contact:
Matsiko Winston
Researcher
Tel: 077936663
Appendix G Healthcare Provider Questionnaire
BY MATSIKO WINSTON
CONTACT: 0779346663
Age:
1. ☐ 20-29
2. ☐ 30-39
3. ☐ 40-49
4. ☐ 50-59
5. ☐ 60 and above
Gender:
1. ☐ Male
2. ☐ Female
3. ☐ Prefer not to say
1. ☐ 0-5 years
2. ☐ 6-10 years
3. ☐ 11-15 years
4. ☐ 16-20 years
5. ☐ More than 20 years
Professional Role:
1. ☐ Physician
2. ☐ Nurse
3. ☐ Diabetes Educator
4. ☐ Pharmacist
5. ☐ Other (please specify): ___________________________
1. ☐ Daily
2. ☐ Weekly
3. ☐ Monthly
4. ☐ Rarely
What are the most common challenges you face in managing diabetes patients? (Select
all that apply)
1. ☐ Medication adherence
2. ☐ Patient education
3. ☐ Lifestyle modifications
4. ☐ Access to medications
5. ☐ Monitoring blood glucose levels
6. ☐ Other (please specify): ___________________________
How do you currently support patients in managing their diabetes? (Select all that apply)
1. ☐ In-person consultations
2. ☐ Educational materials (pamphlets, brochures)
3. ☐ Group education sessions
4. ☐ Follow-up phone calls
5. ☐ Other (please specify): ___________________________
Have you used any mobile health apps for diabetes management before this study?
1. ☐ Yes
2. ☐ No
How easy was it for you to use the mobile app provided in this study?
1. ☐ Very easy
2. ☐ Easy
3. ☐ Neutral
4. ☐ Difficult
5. ☐ Very difficult
How effective do you think the mobile app is in improving medication adherence among
patients?
1. ☐ Very effective
2. ☐ Effective
3. ☐ Neutral
4. ☐ Ineffective
5. ☐ Very ineffective
What features of the mobile app did you find most helpful? (Select all that apply)
1. ☐ Medication reminders
2. ☐ Educational resources
3. ☐ Health tracking tools
4. ☐ Patient support messages
5. ☐ Other (please specify): ___________________________
1. ☐ Yes
2. ☐ No
If yes, how has it influenced your practice? (Select all that apply)
How has the mobile app affected patient outcomes in your experience?
1. ☐ Significant improvement
2. ☐ Moderate improvement
3. ☐ No change
4. ☐ Slight decline
5. ☐ Significant decline
Overall, how satisfied are you with the mobile app intervention for diabetes management?
1. ☐ Very satisfied
2. ☐ Satisfied
3. ☐ Neutral
4. ☐ Dissatisfied
5. ☐ Very dissatisfied
Would you recommend the use of this mobile app to other healthcare providers?
1. ☐ Yes
2. ☐ No
Any additional comments or suggestions: __________________________________