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Online Support Program for Dementia Caregivers (OKenCASA)

The safety and scientific validity of this study is the responsibility of the study
sponsor and investigators. Listing a study does not mean it has been evaluated
by the U.S. Federal Government. Know the risks and potential benefits of clinical
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disclaimer for details.

ClinicalTrials.gov Identifier: NCT04026919

Recruitment Status ! : Recruiting

First Posted ! : July 19, 2019
Last Update Posted ! : July 19, 2019

See Contacts and Locations

Sponsor:
Basque Country University

Information provided by (Responsible Party):

Igone Etxeberria, Basque Country University

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Study Details Tabular View No Results Posted Disclaimer

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Study Description Go to

Brief Summary:

There are currently 50 million people in the world diagnosed with dementia. Due to the detrimental
impact on the mental and physical health of family caregivers different online interventions have
been developed in order to improve their well-being. In this paper, we describe the design of a
randomized controlled trial aiming to study the impact of a multicomponent online program on
primary and secondary caregivers of a person with dementia (PWD).

The experimental group will receive the intervention which is a multicomponent program based on
different components, among others; online psychoeducation, training on psychological skills, a
forum with other caregivers and interaction with a psychologist. Caregivers in the control group will
follow their lifestyle.

More than 250 participants (primary and secondary caregivers) are expected to be recruited via
several sources in the province of Guipuzcoa in Spain. The inclusion criteria for the primary
caregiver are: a) being 18 years or older; b) being the primary caregiver of the PWD; c) more than 6
months caring; and d) give more than 1 hour of caregiving per day. The outcomes of this trial are
caregiver burden (primary outcome), perceived health, depression and anxiety, social support,
satisfaction with care and with the treatment and stress caused by the problem behaviour of the
PWD (secondary outcomes).

Condition or disease ! Intervention/treatment ! Phase !

Effect Increased Other: OK EN CASA-ZAINDOO Not Applicable

Show detailed description

Study Design Go to

Study Type ! : Interventional (Clinical Trial)

Estimated Enrollment ! : 250 participants
Intervention Model: Single Group Assignment

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Masking: None (Open Label)

Masking Description: The random assignment of the participants was carried out
according to the following criteria: 1) Prepare an unpredictable
sequence of random numbers; and, 2) Keep this sequence
hidden until the assignment was carried out. To hide the
sequence, the person in charge of the random assignment
was maintained out of the recruitment and pre-treatment
evaluation.

The assignment was carried out controlling the following

variables: sex, age (over or under 60 years), burden (score> 17
in the Reduced Zarit caregiver burden interview), attendance
or not to the SENDIAN program (psychological support users)
and / or support groups or non-users) of the primary caregiver
and the level of dependence of the elderly person with
dementia (mild / moderate or severe).

Primary Purpose: Treatment

Official Title: OK en Casa - ZAINDOO an Online Support Program for
Caregivers of People With Dementia, a Randomized
Controlled Trial.
Actual Study Start Date ! : September 1, 2018
Estimated Primary Completion Date ! : March 1, 2020
Estimated Study Completion Date ! : March 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

U.S. FDA Resources

Arms and Interventions Go to

Arm ! Intervention/treatment !

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Experimental: to analyze the effectiveness of Ok Other: OK EN CASA-ZAINDOO

en Casa Zaindoo Intervention based on cognitive- behavioural
The multicomponent online programme is techniques offered in an online format.
composed of the components explained in
the detailed study description:

Outcome Measures Go to

Primary Outcome Measures ! :

1. Burden [ Time Frame: Day 0, Month 0 and Day 0, Month 9 ]

Reduced Zarit burden scale (ZBI, Regueiro Pérez, Gómara & Ferreiro, 2007). It consists of 7
items that measures the perceived burden of caregivers via 5-point Likert scale items (0 =
never, 1 = almost never, 2 = sometimes, 3 = many times, and 4 = almost always). This
instrument establishes different degrees of overload depending on the score obtained. Scores
lower than 17 are indicative that there is no overload, while scores higher than 17 indicate the
existence of it.

Secondary Outcome Measures ! :

1. Memory and behavior problems [ Time Frame: Day 0, Month 0 and Day 0, Month 9 ]

Memory and Behavior Problems Checklist (MBCL, Zarit & Zarit, 1982, translated by Izal &
Montorio, 1994). This inventory consists of two subscales that measure the frequency of
appearance of each problem and the stress caused to the caregiver. Each of these
subscales consists of 30 items that are evaluated by a Likert-type scale with response
options ranging from 0 to 4. In this study, the first 17 items that refer to problematic
behaviors were applied.

2. Health status [ Time Frame: Day 0, Month 0 and Day 0, Month 9 ]

collected by the following item: "In general, you would say that your health is very good,
good, fair, bad or very bad". This item has been validated as a valid measure of the
subjective perception of health in national and international studies.

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collected by the following item: "In general, you would say that your health is very good,
good, fair, bad or very bad".

3. Anxiety and depression [ Time Frame: Day 0, Month 0 and Day 0, Month 9 ]

The Hospital Anxiety and Depression Scale (Zigmond & Snaith, 1983). The tool includes 14
items and was designed for the evaluation of anxiety and depression in non-psychiatric
outpatient hospital services. Seven items are related to anxiety and seven associated with
depression, each scored between 0 (never) and 3 (almost all day). The authors
recommended that a score above 8 on an individual scale should be regarded as a possible
case and a score above 11 a probable case. It is a useful instrument validated in our
environment (Quintana, Padierna, Esteban, Aróstegui, Bilbao, & Ruiz, 2003).

4. Social support [ Time Frame: Day 0, Month 0 and Day 0, Month 9 ]

Family APGAR (Bellón, Delgado, Luna, & Lardielli, 1996). This scale shows the level of
perceived dysfunctionality of a family unit assessed in a global way. The person evaluates
each of the items using a Likert scale that oscillates between 0 (almost never) and 2 (almost
always). The cut off points on the scale are the following: 0 to 2 points would indicate that
there is a severe dysfunctionality among the family, between 3 and 6 would be slightly
dysfunctional families, and finally, scores between 7 and 10 would indicate that it is a
normo-functional family.

5. Satisfaction with care [ Time Frame: Day 0, Month 0 and Day 0, Month 9 ]

The Caregiving Satisfaction Scale (CSS, Lawton, Kleban, Moss, Rovine & Glicksman, 1989,
Spanish version of Lopez & Crespo, 2003). This scale measures the satisfaction of the
caregiver from the caregiving situation. It consists of 6 items and the respondents are asked
to rate each statement on a five-point scale ranging from 1 (strongly agree) to 5 (strongly
disagree). Higher numbers reflect lesser satisfaction from the caregiving situation.

6. Satisfaction with the treatment [ Time Frame: Day 0, Month 0 and Day 0, Month 9 ]

The Client Satisfaction Questionnaire (CSQ, Larsen, Attkinson, Hargreaves & Nguyen, 1979).
This questionnaire will be administered to the caregivers in the experimental group at the
end of the intervention program. Consists of a structured survey used to assess the level of
satisfaction with the treatment. Items are scored on a Likert scale from 1 (low satisfaction)

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to 4 (high satisfaction) with different descriptors for each response point. Total scores range
from 8 to 32, with higher scores indicating greater satisfaction.

Eligibility Criteria Go to

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with

your doctor and family members or friends about deciding to join a study. To
learn more about this study, you or your doctor may contact the study research
staff using the contacts provided below. For general information, Learn About
Clinical Studies.

Ages Eligible for Study: Child, Adult, Older Adult

Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

To be the main caregiver of the person with dementia

To be over 18 years of age

Provision of at least 6 months of care

Provide at least one hour of care per day.

Exclusion Criteria:

Having a contractual relationship for caring issues with the elderly person with dementia or with
its family
Have a disease that makes participation difficult during this pilot study (18 months)

Not to have dementia.

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Contacts and Locations Go to

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study
research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number):

NCT04026919

Contacts

Contact: Igone Etxeberria, Doctor +34 653747655 igone.etxeberria@ehu.eus

Locations

Spain

University of the Basque Country Completed

San Sebastián, Guipuzcoa, Spain, 20018

University of the Basque Country Recruiting

San Sebastián, Guipuzcoa, Spain, 20018

Contact: Igone Etxeberria, doctor

Sponsors and Collaborators

Basque Country University

Investigators

Principal Investigator: Igone Etxeberria, doctor Basque Country University

More Information Go to

Responsible Party: Igone Etxeberria, Principal Investigator, Basque Country University

ClinicalTrials.gov Identifier: NCT04026919 History of Changes

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Other Study ID Numbers: 00423

First Posted: July 19, 2019 Key Record Dates

Last Update Posted: July 19, 2019

Last Verified: July 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No

Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Dementia Nervous System Diseases
Brain Diseases Neurocognitive Disorders
Central Nervous System Diseases Mental Disorders

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