Research

JAMA Psychiatry | Original Investigation

Effectiveness and Safety of Dementia Care Management

in Primary Care
A Randomized Clinical Trial
Jochen René Thyrian, PhD; Johannes Hertel, Dipl-Psych; Diana Wucherer, Dipl-Pharm; Tilly Eichler, PhD; Bernhard Michalowsky, PhD;
Adina Dreier-Wolfgramm, PhD; Ina Zwingmann, PhD; Ingo Kilimann, MD; Stefan Teipel, MD; Wolfgang Hoffmann, MD, MPH

Supplemental content
IMPORTANCE Dementia care management (DCM) can increase the quality of care for people
with dementia. Methodologically rigorous clinical trials on DCM are lacking.

OBJECTIVE To test the effectiveness and safety of DCM in the treatment and care of people
with dementia living at home and caregiver burden (when available).

DESIGN, SETTING, AND PARTICIPANTS This pragmatic, general practitioner–based,

cluster-randomized intervention trial compared the intervention with care as usual at
baseline and at 12-month follow-up. Simple 1:1 randomization of general practices in Germany
was used. Analyses were intent to treat and per protocol. In total, 6838 patients were
screened for dementia (eligibility: 70 years and older and living at home) from January 1,
2012, to March 31, 2016. Overall, 1167 (17.1%) were diagnosed as having dementia, and 634
(9.3%) provided written informed consent to participate.

INTERVENTIONS Dementia care management was provided for 6 months at the homes of
patients with dementia. Dementia care management is a model of collaborative care, defined
as a complex intervention aiming to provide optimal treatment and care for patients with
dementia and support caregivers using a computer-assisted assessment determining a
personalized array of intervention modules and subsequent success monitoring. Dementia
care management was targeted at the individual patient level and was conducted by 6 study
nurses with dementia care–specific qualifications.

MAIN OUTCOMES AND MEASURES Quality of life, caregiver burden, behavioral and
psychological symptoms of dementia, pharmacotherapy with antidementia drugs, and use of
potentially inappropriate medication.
Author Affiliations: German Center
for Neurodegenerative Diseases
RESULTS The mean age of 634 patients was 80 years. A total of 407 patients received the (DZNE), Greifswald, Germany
intended treatment and were available for primary outcome measurement. Of these patients, (Thyrian, Hertel, Wucherer, Eichler,
248 (60.9%) were women, and 204 (50.1%) lived alone. Dementia care management Michalowsky, Zwingmann,
Hoffmann); Department of
significantly decreased behavioral and psychological symptoms of dementia (b = −7.45; 95% CI, Psychiatry and Psychotherapy,
−11.08 to −3.81; P < .001) and caregiver burden (b = −0.50; 95% CI, −1.09 to 0.08; P = .045) Greifswald Medical School, University
compared with care as usual. Patients with dementia receiving DCM had an increased chance of of Greifswald, Greifswald, Germany
(Hertel); Institute for Community
receiving antidementia drug treatment (DCM, 114 of 291 [39.2%] vs care as usual, 31 of 116
Medicine, Section Epidemiology of
[26.7%]) after 12 months (odds ratio, 1.97; 95% CI, 0.99 to 3.94; P = .03). Dementia care Health Care and Community Health,
management significantly increased quality of life (b = 0.08; 95% CI, 0 to 0.17; P = .03) for Greifswald Medical School, University
patients not living alone but did not increase quality of life overall. There was no effect on of Greifswald, Greifswald, Germany
(Dreier-Wolfgramm, Hoffmann);
potentially inappropriate medication (odds ratio, 1.86; 95% CI, 0.62 to 3.62; P = .97).
German Center for
Neurodegenerative Diseases (DZNE),
CONCLUSIONS AND RELEVANCE Dementia care management provided by specifically trained Rostock, Germany (Kilimann, Teipel);
nurses is an effective collaborative care model that improves relevant patient- and Department of Psychosomatic
Medicine, Rostock University Medical
caregiver-related outcomes in dementia. Implementing DCM in different health care systems Center, Rostock, Germany (Teipel).
should become an active area of research. Corresponding Author: Jochen René
Thyrian, PhD, German Center for
TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01401582 Neurodegenerative Diseases (DZNE),
site Rostock/Greifswald,
JAMA Psychiatry. 2017;74(10):996-1004. doi:10.1001/jamapsychiatry.2017.2124 Ellernholzstr. 1/2, 17489 Greifswald,
Published online July 26, 2017. Germany (rene.thyrian@dzne.de).

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 Effectiveness and Safety of Dementia Care Management
D
ementia is a public health priority that affects 47.5 mil-
lion people worldwide.1 The rapidly growing number
of people with dementia presents a challenge to the
health care systems. People with dementia need comprehen-
sive medical, nursing, psychological, and social support to de-
lay the progression of disease and sustain autonomy and so-
cial inclusion. Primary care has been identified as the first point
of contact for people with dementia and is thus a promising
setting for identification, comprehensive needs assessment,
and initiating dementia-specific treatment and care.2 How-
ever, primary care systems worldwide are insufficiently pre-
pared for these tasks.3-6
Evidence-based interventions alleviate the burden of dis-
ease, as no curative treatment is currently available. Involv-
ing caregivers in intervention is important because they pro-
vide the largest proportion of care for people with dementia.
The burden of informal care7-9 is the main determinant of nurs-
ing home admissions of people with dementia,10,11 and infor-
mal care contributes the most to total care costs.12,13 General
challenges in the management of dementia include provid-
ing antidementia drug treatment, addressing neuropsychiat-
ric symptoms and behavioral problems, reducing inappropri-
ate psychoactive medication use, and managing caregiver
burden.14 Collaborative care programs address these chal-
lenges. There is some evidence that programs for general prac-
titioner (GP)–based dementia care can be successfully imple-
mented into health systems.15 However, presently the scientific
evidence does not match the enthusiasm for these programs.16
There is a need to test the effectiveness of care management
before implementation in primary care.17
A Cochrane review18 from 2015 analyzing 13 randomized
clinical trials revealed beneficial effects of care management,
specifically in reducing patients’ behavior disturbance, and
caregivers’ burden and depression as well as in improving care-
givers’ well-being and social support. However, there is hetero-
geneity in interventions, study designs, sample size, and out-
comes measured. Thus, the review concluded that studies that
are rigorous in design and intervention delivery are needed.18
Intervention modules and a standard set of outcome mea-
sures should furthermore be clearly defined to improve
comparability.18-20
The present randomized clinical trial describes the effec-
tiveness of dementia care management (DCM) on relevant pa-
tient- and caregiver-oriented outcomes, including (1) quality
of life, (2) caregiver burden, (3) behavioral and psychological
symptoms of dementia, (4) pharmacotherapy with anti-
dementia drugs, and (5) use of potentially inappropriate
medication (PIM). Dementia care management uses a
well-defined, computer-supported, 21 and model-based
intervention22 implemented by specifically trained nurses.23
Methods
Trial Design
The Dementia: Life- and Person-Centered Help in Mecklenburg-
Western Pomerania (DelpHi) trial was a pragmatic, GP-based,
cluster-randomized intervention study with 2 arms, an inter-
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Original Investigation Research
Key Points
Question What is the effect of dementia care management, a
model of collaborative care, on the treatment and care of people
with dementia and their caregivers in primary care?
Findings In this randomized clinical trial of 634 people with
dementia, dementia care management significantly reduced
neuropsychiatric symptoms and caregiver burden and increased
use of antidementia drugs compared with care as usual. Dementia
care management was found to be a safe intervention.
Meaning Dementia care management may significantly improve
the outcomes of treatment and care among people with dementia
and caregiver burden and should be incorporated into routine
care.
vention group and a care as usual (CAU) group. The study pro-
tocol was approved by the Ethical Committee of the Chamber
of Physicians of Mecklenburg-Western Pomerania, Germany
(registry number BB 20/11). The reporting of this study fol-
lows the CONSORT statement24 and its extensions regarding
cluster-randomized,25 pragmatic trials26 with nonpharmaco-
logic treatments.27 The design, eligibility and inclusion crite-
ria, intervention, and baseline characteristics of the trial have
been described in detail elsewhere.21-23,28 The full trial proto-
col is available in Supplement 1.
Clusters
General practices were the unit of randomization and deter-
mined the patients’ group status. A total of 854 GPs in 5 mu-
nicipalities of Mecklenburg-Western Pomerania were invited
to participate by mail. General practitioners expressing an in-
terest in the study were visited by the investigators to convey
additional detailed information about the study. Finally, 136
GPs (15.9%) gave written informed consent to participate and
agreed to adhere to the DelpHi trial protocol. There were no
restrictions regarding the GPs’ treatment of patients.
Participants
General practitioners assessed the eligibility of patients (≥70
years, living at home) and systematically screened patients who
met the inclusion criteria using the DemTect procedure.29 This
interview-based instrument is widely used for dementia
screening in GP practices in Germany and is more sensitive than
the Mini-Mental State Examination for detecting milder forms
of cognitive impairment (DemTect, 98% vs Mini-Mental State
Examination, 46%).30,31 Thus, it is possible that some pa-
tients screened positive for dementia by the DemTect proce-
dure are not considered cognitively impaired according to the
Mini-Mental State Examination (score 27 to 30 of 30).
Study enrollment started January 1, 2012, and ended De-
cember 31, 2014. The follow-up period ended on March 31,
2016. Patients who screened positive for dementia were in-
formed about the study by their GP, invited to participate, and
asked to provide written informed consent. If the patients listed
a caregiver, he or she was asked to participate as well. When
patients were unable to provide written informed consent, their
legal representative was asked to sign the consent form on their
(Reprinted) JAMA Psychiatry October 2017 Volume 74, Number 10 997
 Research Original Investigation
behalf. General practitioners received allowances for screen-
ing (€10 [US $11.15] per patient) and study enrollment (€100
[US $111.54] per patient).
Intervention
Dementia care management aims to provide optimal care by
integrating multiprofessional and multimodal strategies for im-
proving patient- and caregiver-related outcomes within the
framework of the established health care and social service sys-
tem. It was developed according to current guidelines,32,33 tar-
geted at the individual participant level, and delivered at pa-
tients’ homes by 6 nurses with dementia-specific qualifications
supported by a computer-based intervention-management sys-
tem (IMS) to improve systematic identification of patients’ and
caregivers’ unmet needs. The nurses conducted an in-depth
assessment. Based on these data, the IMS generated an indi-
vidual preliminary intervention task list, and the nurses dis-
cussed and finalized the task list in a weekly interdisciplinary
case conference with a nursing scientist, a neurologist/
psychiatrist, a psychologist, and a pharmacist. Afterwards, the
list of intervention tasks was summarized in a semistandard-
ized GP information letter. This letter was then discussed be-
tween the GP and nurse to establish an individual treatment
plan. During the first 6 months of the intervention period, the
nurse conducted 6 home visits with an average duration of 1
hour, carrying out his or her standard intervention tasks in close
cooperation with the caregiver, the GP, and health care and so-
cial service professionals. During the subsequent 6 months,
the study nurse monitored the completion of all intervention
tasks. In line with the Pacala scale34 for intensive case man-
agements, each study nurse delivered intervention to, on av-
erage, 60 patients with dementia. Training, intervention, and
the IMS are described in more detail elsewhere28,35 and in the
eAppendix in Supplement 2.
Outcomes
The primary outcomes were assessed within identical, stan-
dardized, computer-assisted face-to-face interviews at the pa-
tients’ homes by specifically qualified nurses over an average
of 3 separate visits at baseline and 12 months after baseline and
pertain to the individual patients’ (1) quality of life, measured
by the Quality of Life in Alzheimer Disease instrument,36 which
assesses physical health, mental health, and social and finan-
cial domains; (2) caregiver burden, measured by the Berlin In-
ventory of Caregivers’ Burden with Dementia Patients, an in-
ventory with 88 items in 20 different dimensions, which
assesses subjective and objective burden37; (3) behavioral and
psychological symptoms, measured by the Neuropsychiatric
Inventory, an interview by proxy on 12 dimensions of neuro-
psychiatric behaviors38; (4) use of pharmacotherapy with an-
tidementia drugs, which included the following substances rec-
ommended by relevant guidelines: donepezil, galantamine,
rivastigmine, and memantine; and (5) use of PIM, which is de-
fined as a drug for which the risk of an adverse drug effect out-
weighs the clinical benefit and evaluated using the PRISCUS
criteria.39-41 The predefined secondary outcomes included cog-
nitive status, measured using the Mini-Mental State
Examination42; activities of daily living, measured using the
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Effectiveness and Safety of Dementia Care Management
Bayer-Activities of Daily Living Scale; and health care re-
source use, especially institutionalization.43,44
Sample Size
No previous data on the main outcome measures were avail-
able for sample size calculation. Therefore, sample size was
estimated based on theoretical assumptions. In the design, the
minimally important difference for determining the effective-
ness was considered to be of at least a small effect, defined by
Cohen d (Cohen d = 0.2).45 Comparing 2 groups at a signifi-
cance level of α = .05, assuming a statistical power of 80% and
an intraclass correlation with clustering by GP practice of 0, a
sample size of 310 persons per group would have been
sufficient. 45 Considering the longitudinal design, we ac-
counted for a loss over time of 35% (eg, death or withdrawal
of informed consent) and determined that 477 persons per
group with complete data sets would have been needed to be
included in the study. We estimated that GPs would identify
1000 patients over the course of 2 years. Recruitment turned
out to be slower than expected. Thus, recruitment was pro-
longed from 2 to 3 years. The achieved sample size allows to
detect a medium effect size (Cohen d = 0.5).45
Randomization and Allocation
We used simple 1:1 randomization without stratification or
matching. This procedure was sufficient because of the high
number of expected clusters in our study.46 General practition-
ers were not informed of their randomization status. However,
because of the type of intervention, GPs became aware of their
status throughout the course of the study. Patients were re-
cruited and enrolled by participating GPs but allocated to the
study group by study center. Because baseline assessment, pri-
mary outcome assessment, and delivery of intervention needed
to be performed by the same nurses, blinding was not possible.
Statistical Methods
Descriptive Statistics
To describe the sample, metric variables were summarized as
means and SD, and nominal variables were presented as pro-
portions. Baseline and follow-up values were compared using
paired t tests or McNemar tests, as applicable.
Primary Analyses
The primary analyses (intention to treat [ITT] and per protocol)
included generalized regression models, with a model specifi-
cation corresponding to the scale level of the outcome variable.
The ITT analysis was performed as modified ITT for all cases with
valid baseline data,47 and the per-protocol analysis included com-
plete cases only. Missing data in the follow-up variables were im-
puted by multiple imputations via chained equations. The out-
come variable at follow-up was the dependent variable, and
study group was the predictor of interest. To account for the sto-
chastic dependency of patients treated by the same GP, GPs were
included as random effects. The baseline value of the outcome
variable was included as a covariate to reduce residual variance
and to account for interindividual variance at baseline. Further-
more, age, sex, and living situation (alone vs not alone) were in-
cluded as covariates. A positive intervention effect was defined
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 Effectiveness and Safety of Dementia Care Management Original Investigation Research

Figure. CONSORT Flow Diagram

854 Eligible general practitioners

136 General practitioners provided informed consent

136 Randomized

80 General practitioners allocated to 56 General practitioners allocated to care

dementia care management group as usual group (control)
(intervention)

4011 Patients screened for dementia 2827 Patients screened for dementia
(≤70 years, living at home) (≤70 years, living at home)
73 General practitioners included 52 General practitioners included

707 Eligible patients (DemTect score, <9) 460 Eligible patients (DemTect score, <9)
61 General practitioners included 44 General practitioners included

408 Patients provided informed consent 226 Patients provided informed consent
58 General practitioners included 37 General practitioners included

58 Patients lost to baseline

60 Patients lost to baseline 44 Withdrew informed consent
41 Withdrew informed consent 7 Died
12 Died 2 Changed region
3 Changed region 5 Other
4 Other 2 General practitioners lost
to baseline

348 Patients at baseline 168 Patients at baseline

58 General practitioners at baseline 35 General practitioners at baseline

11 Patients lost within baseline

9 Withdrew informed consent 4 Patients lost within baseline
1 Died 3 Withdrew informed consent
1 Changed region 1 Other
2 General practitioners lost
within baseline

337 Patients completed baseline 164 Patients completed baseline

56 General practitioners completed baseline 35 General practitioners completed baseline

48 Patients lost to follow-up

46 Patients lost to follow-up 31 Withdrew informed consent
17 Withdrew informed consent 12 Died
22 Died 1 Changed region
1 Changed region 4 Other
6 Other 5 General practitioners lost
to follow-up

291 Patients at follow-up 116 Patients at follow-up

56 General practitioners at follow-up 30 General practitioners at follow-up

as a significant regression coefficient of the study group vari-
able. Sensitivity analyses were performed by introducing ran-
dom slopes for the difference of DCM vs CAU and the baseline
variable of the outcome and recalculating the P values and 95%
CIs by bootstrapping (2000 replications). All P values for the pri-
mary analyses are 1-sided. Data analysis and management were
conducted using Stata version 13.1 (StataCorp). Details of the sta-
tistical analyses are provided in Supplement 1.
Secondary Analyses
Because the intervention targeted the patients’ entire social
system, exploratory prior analyses, prespecified in the analy-
sis plan, were conducted by stratifying the models by pa-
tients’ living situation, identifying whether the intervention
would show stronger effects in persons living alone or not liv-
ing alone.
Results
Participant Flow
The CONSORT statement is illustrated in the Figure. Overall,
634 patients provided written informed consent, and a total
of 407 (64.2%) received the intended treatment (DCM, 291

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 Research Original Investigation
Table 1. Regression Analyses for the Treatment Effect of Dementia Care Managementa
Primary Outcome Observations, No.
Quality of life (QoL-AD score) 379
Neuropsychiatric symptoms (NPI score) 261
Caregiver burden (BIZA-D score) 241
Antidementia drug treatmentb 401
Potentially inappropriate medicationc 401
Abbreviations: BIZA-D, Berlin Inventory of Caregivers’ Burden with Dementia
Patients; NA, not applicable; NPI, Neuropsychiatric Inventory; Qol-AD, Quality
of Life in Alzheimer’s Disease.
a
Mixed-effect regression analyses with random effects for general practitioner
adjusted for age, sex, living situation, and baseline value; the study group was
the predictor of interest; P values are given 1-sided.
[71.5%]; CAU, 116 [28.5%]). Whereas all 407 participants were
included in the per-protocol analyses, in the ITT analyses, all
patients with valid baseline variables were included (Table 1).
In total, 227 patients were lost to follow-up. Most of the pa-
tients dropped out before starting the baseline assessment at
home (118 of 634 [18.6%]), which took place on average 138 days
after initial screening by the GP because of the study proce-
dure. The dropout rate between completion of baseline and
follow-up was lower (94 of 516 [18.2%]) and more frequent in
the control group (DCM, 46 of 348 [13.2%] vs CAU, 48 of 168
[28.6%]). There were no statistical differences between pa-
tients assessed at follow-up (n = 407) and those who dropped
out before follow-up (n = 227) in age, sex, and DemTect score
(eTable 1 and eTable 2 in Supplement 2). The intervention was
safe, as no dropout was reported because of GPs’ advice or
problems with the intervention reported by the patients with
dementia or the caregiver. There was no significant effect of
the study group on mortality.
Baseline Data
Participant characteristics at baseline and follow-up are sum-
marized in Table 2. Primary outcome measures for baseline and
follow-up are given by group in Table 3. The groups did not dif-
fer significantly according to primary outcomes and sociode-
mographic variables (eTable 3 in Supplement 2) in the ITT
analyses data set. In the per-protocol analyses set, the CAU
group reported a significantly higher quality of life.
Outcomes and Estimation
In the primary ITT analyses, a significant decrease in pa-
tients’ behavioral and psychological symptoms of dementia
(b = −7.45; 95% CI, −11.08 to −3.81; P < .001) and caregiver bur-
den (b = −0.50; 95% CI, −1.09 to 0.08; P = .05) was observed
in the intervention group compared with CAU. Patients with
dementia receiving DCM had an increased chance of receiv-
ing antidementia drug treatment (DCM, 114 of 291 [39.2%] vs
CAU, 31 of 116 [26.7%]) after 12 months (odds ratio, 1.97; 95%
CI, 0.99 to 3.94; P = .03). There was no effect on quality of life
(b = 0.02; 95% CI, −0.09 to 0.05; P = .26) or on PIMs (DCM, 77
[26.5%] vs CAU, 19 [16.4%]; odds ratio, 1.86; 95% CI, 0.62 to
3.62; P = .97) after 12 months. The secondary analyses indi-
cated a significant effect on quality of life in the intervention
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Effectiveness and Safety of Dementia Care Management
Treatment Effect
b (95% CI) P Value Effect Size
0.02 (−0.09 to 0.05) .26 0.07
−7.45 (−11.08 to −3.81) 0 −0.50
−0.50 (−1.09 to 0.08) .045 −0.18
1.97 (0.99 to 3.94)d .03 NA
1.86 (0.62 to 3.62)d .97 NA
b
Antidementia drugs: donepezil, rivastigmine, galantamine, memantine, and
donepezil and memantine.
c
According to PRISCUS list.
d
Odds ratio (95% CI).
group (b = 0.08; 95% CI, 0 to 0.17; P = .03) for patients not liv-
ing alone (Table 4).
According to secondary outcomes, we found no signifi-
cant effect on patient’s cognitive status, daily living activi-
ties, or institutionalization. Overall, 24 of 407 patients (5.9%)
were institutionalized 1 year after baseline (DCM, 16 [5.5%] vs
CAU, 8 [6.9%]).
Sensitivity analyses confirmed the results of the ITT analy-
ses. As expected, the clinical characteristics showed serious clus-
tering, and sociodemographic variables, such as sex, age, and
living status, were not GP-dependent. The per-protocol analy-
ses, sensitivity analyses, and the intraclass correlations for the
main outcomes are reported in eTable 4 in Supplement 2.
Discussion
In our study, DCM was beneficial for optimizing treatment and
care in patients with dementia. We found medium to large ef-
fects of DCM for community-dwelling patients with demen-
tia in primary care on behavioral and psychological symp-
toms, caregiver burden, and pharmacologic treatment with
antidementia drugs. Referring to neuropsychiatric symp-
toms measured by the Neuropsychiatric Inventory, a de-
crease in 4 points would be regarded as clinically meaningful.38
In our analysis, DCM reduced neuropsychiatric symptoms by
8 points, with a larger effect size compared with previous stud-
ies included in the Cochrane review by Reilly et al48 (standard-
ized mean difference, −0.20; 95% CI of difference, −0.41 to
0.01; n = 368; I2 = 83%; P = .06). Referring to caregiver bur-
den, the effect size of the DCM was medium but larger when
compared with other studies (−0.18 vs −0.07).48 Thus, our re-
sults indicate meaningful clinical relevance. The study meth-
ods were in line with the demand to use standardized sets of
outcome measures20 and well-defined interventions19 to im-
prove comparability across studies, and our results contrib-
ute empirical evidence to currently inconclusive research18 on
DCM approaches in primary care.
The results suggest that DCM increased the quality of de-
mentia care. Improvements included a higher use of antide-
mentia drugs. Although this is a simple proxy for good medi-
cal dementia care, the data do not indicate whether drug
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 Effectiveness and Safety of Dementia Care Management Original Investigation Research

treatment conformed to guidelines. To our knowledge, there

Table 2. Baseline Characteristics of Patients With Dementiaa
is no benchmark for the percentage of people who should be
treated with antidementia drugs in primary care that we could Dementia Care
Care as Usual Management
have used for comparison. Our data suggested the use of a care- Characteristic (n = 116) (n = 291)
ful approach with antidementia drug treatment, with a preva- Age, mean (SD), y 79.8 (5.0) 80.6 (5.7)
lence of 39% in the intervention group. This proportion is com- Female 70 (60.3) 178 (61.2)
parable with other studies.49,50 Use of antidementia drugs is Caregiver included 75 (64.7) 227 (78.0)
recommended in many international guidelines.51 However, Not living alone 58 (50.0) 148 (50.9)
assessing adherence to guidelines in their full complexity could Living alone 53 (45.7) 151 (51.9)
not be done in this study because of limited sample size. Cognitive status (MMSE score), 22.7 (5.2) 22.8 (4.6)
Neuropsychiatric symptoms and caregiver burden are mean (SD)
among the most important risk factors for institutionaliza- Severity of dementia according
to MMSEb
tion of people with dementia.10,11 To our knowledge, our study No hint for 28 (24.8) 66 (23.2)
is the first to show positive effects on both factors.52,53 An-
Mild 58 (51.3) 143 (50.2)
other risk factor is functional inabilities.10 Because the use of
Moderate 21 (18.6) 69 (24.2)
antidementia drugs can have a positive impact on functional
Severe 6 (5.3) 7 (2.5)
abilities,32 all 3 effects of DCM are likely synergistical to delay
Formal diagnosis of dementia 43 (37.1) 113 (38.8)
institutionalization. This could save long-term costs.
Functional impairment 3.2 (2.4) 3.8 (2.6)
A small effect on quality of life was restricted to patients (B-ADL score), mean (SD)
not living alone. This result should not be overestimated be- Comorbidities, mean (SD)c 14.0 (6.9) 13.5 (8.0)
cause validity and reliability of quality of life measures in Visit to neurologist/psychiatrist,d,e 21 (18.8) 86 (30.1)
people with dementia are limited. However, this finding im- Quality of life (Qol-AD score), 2.8 (0.4) 2.7 (0.4)
plies that further analyses could identify target groups with mean (SD)e
an increased benefit. We speculate that the effectiveness of Neuropsychiatric symptoms 7.2 (9.8) 7.6 (14.6)
(NPI score), mean (SD)
DCM could be associated with socioeconomic status, func-
Antidementia drug treatment 27 (23.5) 84 (28.9)
tional ability, or severity of dementia.
Potentially inappropriate medicationf 25 (21.7) 72 (24.7)
There was no effect of DCM on the frequency of PIMs. This
Caregiver burden (BIZA-D score), −0.07 (2.57) −0.14 (2.62)
is unexpected because comprehensive medication manage- mean (SD)
ment was part of the intervention. We speculate that the in- Abbreviations: B-ADL, Bayer-Activities of Daily Living; BIZA-D, Berlin Inventory
tensity was probably too low in this trial because recommen- of Caregivers’ Burden with Dementia Patients; MMSE, Mini-Mental State
dations to the GP regarding pharmacologic treatment were Examination; NPI, Neuropsychiatric Inventory; Qol-AD, Quality of Life in
Alzheimer’s Disease.
provided only once. An effective reduction of PIMs may re-
a
Data are reported as No. (%) unless otherwise indicated.
quire a higher intensity of care management and follow-up
b
Nine scores are missing (3 care as usual, 6 dementia care management).
reviews.54
c
Number of International Statistical Classification of Diseases and Related
Health Problems, Tenth Revision diagnoses recorded in medical record of
Limitations treating general practitioners.
Screening and recruitment were part of routine care so that se- d
Nine scores are missing (4 care as usual, 5 dementia care management).
lection bias cannot be ruled out. Any systematic control mecha- e
Indicates a statistically significant difference between care as usual and
nisms would have interfered with GPs’ routine, causing ad- dementia care management (from generalized linear regressions with random
verse effects, including dropout of GPs. However, all intercepts for the general practitioner).
f
participating GPs agreed to recruit systematically while ad- According to PRISCUS list.
hering to the requirements of the study design.
The number of participants was imbalanced between the
intervention and control groups. Fewer GPs were random-
ized to the control group. Furthermore, there was the ten- Generalizability
dency that GPs in the control group included less patients. We The study was incorporated into routine care as closely as pos-
expect that during the trial, GPs noticed their assignment, sible so that the external validity of the results is high. How-
which resulted in a loss of motivation for an inclusion of fur- ever, because of the rigorous design in the context of this trial,
ther patients. However, there were no significant group dif- there were restrictions in time, length, and content of DCM ac-
ferences according to primary outcomes or sociodemo- tivities. In routine care, nurses have more freedom to decide
graphic variables. what, when, and how activities are performed. Additionally,
The DelpHi trial was not a diagnostic trial. The identifica- generalizability might be limited because of the region and
tion of patients with dementia was based on a screening in- health care system being studied. It is possible that differ-
strument. A state-of-the-art diagnostic procedure was not re- ences in access and availability of health care resources in other
quired. However, the DemTect was designed for this specific health care systems may affect the effectiveness. However,
purpose and is widely used in routine care.30,55,56 Further- challenges of dementia care are mainly triggered by the dis-
more, the main analysis was ITT, and any false positives would ease itself and require similar resources that are available in
have caused an underestimation of the intervention effect. different regions and health systems.

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 Research Original Investigation Effectiveness and Safety of Dementia Care Management

Table 3. Primary and Secondary Outcomes for Care as Usual vs Dementia Care Management

Care as Usual (n = 116) Dementia Care Management (n = 291)

Characteristic Baseline After 12 mo P Valuea Baseline After 12 mo P Valuea
Primary outcomes
Quality of life (Qol-AD score), 2.8 (0.4) 2.8 (0.3) .08 2.7 (0.4) 2.8 (0.4) .70
mean (SD)
Neuropsychiatric symptoms 7.2 (9.8) 15.2 (16.9) .001 7.6 (14.6) 8.2 (13.6) .60
(NPI score), mean (SD)
Antidementia drug treatment, No. (%)b 27 (23.5) 31 (26.7) .13 84 (28.9) 114 (39.2) .001
Potentially inappropriate medication, 25 (21.7) 19 (16.3) .13 72 (24.7) 77 (26.5) .47
No. (%)c
Caregiver burden (BIZA -D score), −0.07 (2.57) 0.40 (2.62) .14 −0.14 (2.62) −0.13 (2.63) .99
mean (SD)
Secondary outcomes
Cognitive status (MMSE score), 22.7 (5.2) 21.9 (6.0) .03 22.8 (4.6) 21.2 (5.7) .001
mean (SD)
Functional impairment (B-ADL score), 3.2 (2.4) 4.4 (2.9) .001 3.8 (2.6) 4.9 (2.9) .001
mean (SD)
Abbreviations: BIZA-D, Berlin Inventory of Caregivers’ Burden with Dementia differences in dichotomous variables, McNemar tests were used).
Patients; B-ADL, Bayer-Activities of Daily Living; MMSE, Mini-Mental State b
Antidementia drugs: donepezil, rivastigmine, galantamine, memantine, and
Examination; NPI, Neuropsychiatric Inventory; Qol-AD, Quality of Life in donepezil and memantine.
Alzheimer’s Disease. c
According to PRISCUS list.
a
P values for statistical comparison between baseline and follow-up (for
differences in means, paired t tests for differences were calculated; for

Table 4. Secondary Regression Analysis to Predict Effect of Dementia Care Management Depending on Living Statusa

Treatment Effect Effect Size

Living Alone Not Living Alone
Measurement Living Not Living
Outcome Variable Scale b (95% CI) P Value b (95% CI) P Value Alone Alone
Quality of life QoL-AD score −0.03 (−0.06 to 0.13) .51 0.08 (0 to 0.17) .03 −0.08 0.25
Neuropsychiatric NPI score −9.29 (−14.74 to −4.11) .001 −6.30 (−11.63 to −0.99) .01 −0.70 −0.39
symptoms
Caregiver burden BIZA-D score −0.38 (−1.31 to 0.55) .21 −0.70 (−1.22 to 0.01) .03 −0.15 −0.24
Antidementia drug Antidementia 1.88 (0.69 to 5.16)c .11 1.91 (0.72 to 5.05)c .10 NA NA
treatment drugsb
Potentially According to 2.16 (0.80 to 5.18)c .91 1.63 (0.70 to 3.78)c .86 NA NA
inappropriate PRISCUS list
medication
Abbreviations: BIZA-D, Berlin Inventory of Caregivers’ Burden with Dementia the predictor of interest.
Patients; NA, not applicable; NPI, Neuropsychiatric Inventory; Qol-AD, Quality b
Antidementia drugs: donepezil, rivastigmine, galantamine, memantine, and
of Life in Alzheimer’s Disease. donepezil and memantine.
a
Mixed-effect regression analyses with random effects for general practitioner c
Odds ratio (95% CI).
in the subsamples of patients living alone and patients not living alone;
adjusted for age, sex, living situation, and baseline value; the study group was

caregiver-related effects on treatment and care. Therefore, imple-

Conclusions
Dementia care management provided by specially trained nurses
and supported by a computer-based IMS is an effective and safe
collaborative care model that has clinically relevant patient- and
mentation in routine care could be beneficial for people with de-
mentia and their relative caregivers. Further analyses should
identify specific subgroups of people with dementia with higher
effectiveness of DCM and should evaluate cost-effectiveness to
adapt DCM to other settings and health care systems.

ARTICLE INFORMATION
Accepted for Publication: June 1, 2017.
Published Online: July 26, 2017.
doi:10.1001/jamapsychiatry.2017.2124
Author Contributions: Drs Hoffmann and Thyrian
had full access to all of the data in the study and
take responsibility for the integrity of the data and
the accuracy of the data analysis.
Study concept and design: Thyrian,
Dreier-Wolfgramm, Teipel, Hoffmann.
Acquisition, analysis, or interpretation of data:
Thyrian, Hertel, Wucherer, Eichler, Michalowsky,
Dreier-Wolfgramm, Zwingmann, Kilimann,
Hoffmann.
Drafting of the manuscript: Thyrian, Hertel,
Michalowsky, Zwingmann, Teipel.
Critical revision of the manuscript for important
intellectual content: All authors.
Statistical analysis: Thyrian, Hertel, Teipel.
Obtained funding: Hoffmann.
Administrative, technical, or material support:
Thyrian, Eichler, Zwingmann, Kilimann.
Study supervision: Thyrian, Wucherer,
Dreier-Wolfgramm, Eichler, Teipel, Hoffmann.
Conflict of Interest Disclosures: None reported.
Funding/Support: The study was performed in
cooperation with and funded by the German Center

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 Effectiveness and Safety of Dementia Care Management
of Neurodegenerative Diseases and the University
Medicine of Greifswald.
Role of the Funder/Sponsor: Both funders
participated in and funded the design and conduct
of the study; collection, management, analysis, and
interpretation of the data; preparation, review and
approval of the manuscript; and decision to submit
the manuscript for publication.
Additional Contributions: We acknowledge Ines
Abraham, RN; Ulrike Kempe, RN; Sabine Schmidt,
RN; Vaska Böhmann, RN; Kathleen Dittmer, RN; and
Saskia Moll, RN (Greifswald Medical School,
University of Greifswald, Greifswald, Germany); for
data collection and intervention delivery; Daniel
Fredrich, Dipl-Inf (Greifswald Medical School,
University of Greifswald, Greifswald, Germany), and
Henriette Rau, MSc (German Center for
Neurodegenerative Diseases [DZNE], Rostock/
Greifswald, Germany), for information technology
development and support in conducting the trial;
Kerstin Albuerne, MedDok, and Andrea Pooch, BSc
(DZNE, Rostock/ Greifswald, Germany), for data
collection, data quality assurance, and data
provision; and Viktoria Kim-Böse, MSc, and Kerstin
Wernecke, PhD (DZNE Rostock/ Greifswald,
Germany), for writing and editing assistance as well
as administrative assistance in conducting the trial.
All persons mentioned were compensated for their
contributions as part of their employment.
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