Trial Outcomes & Findings for Intervention Study to Improve Life and Care for People With Dementia and Their Caregivers in Primary Care (NCT NCT01401582)
NCT ID: NCT01401582
Last Updated: 2025-08-20
Results Overview
The Quality of Life in Alzheimer's Disease (Qol-AD; Logsdon et al. 2002) was used. This measure designed specifically to obtain a rating of the patient's quality of life from both the patient and the caregiver. Each item is rated on a four point scale, with 1 being poor and 4 being excellent. Total scores, obtained by the sum of all 13 items, range from 13 to 52.
COMPLETED
NA
634 participants
one year after baseline assessment
2025-08-20
Participant Flow
1/1/2012-12/31/2014 Screening in participating General practices (GP)
Participant milestones
| Measure |
Care as Usual
care as usual, no intervention, just observation of natural change/ trajectories over time
|
Implementation of Dementia Care Manager
Subjects in this arm will be provided with a specialised "Dementia Care Manager" to be included in a subsidiary support system
Provision of a "Dementia Care Manager": Home-visits of trained "Dementia Care Manager (DCM)" at least monthly for 6 months. The DCM will, in close cooperation with the general practitioner, establish and include a subsidiary support system for subjects and their caregivers.
|
|---|---|---|
|
Overall Study
STARTED
|
226
|
408
|
|
Overall Study
Baseline Completed
|
168
|
348
|
|
Overall Study
COMPLETED
|
116
|
291
|
|
Overall Study
NOT COMPLETED
|
110
|
117
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intervention Study to Improve Life and Care for People With Dementia and Their Caregivers in Primary Care
Baseline characteristics by cohort
| Measure |
Care as Usual
n=168 Participants
care as usual, no intervention, just observation of natural change/ trajectories over time
published in Thyrian et al. (2016). Journal of Alzheimer´s Disease (52); 69-617.
|
Implementation of Dementia Care Manager
n=348 Participants
Subjects in this arm will be provided with a specialised "Dementia Care Manager" to be included in a subsidiary support system
Provision of a "Dementia Care Manager": Home-visits of trained "Dementia Care Manager (DCM)" at least monthly for 6 months. The DCM will, in close cooperation with the general practitioner, establish and include a subsidiary support system for subjects and their caregivers.
published in Thyrian et al. (2016). Journal of Alzheimer´s Disease (52); 69-617.
|
Total
n=516 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
79.6 years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
80.2 years
STANDARD_DEVIATION 5.7 • n=7 Participants
|
80.0 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
96 Participants
n=5 Participants
|
211 Participants
n=7 Participants
|
307 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
72 Participants
n=5 Participants
|
137 Participants
n=7 Participants
|
209 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
168 Participants
n=5 Participants
|
348 Participants
n=7 Participants
|
516 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: one year after baseline assessmentThe Quality of Life in Alzheimer's Disease (Qol-AD; Logsdon et al. 2002) was used. This measure designed specifically to obtain a rating of the patient's quality of life from both the patient and the caregiver. Each item is rated on a four point scale, with 1 being poor and 4 being excellent. Total scores, obtained by the sum of all 13 items, range from 13 to 52.
Outcome measures
| Measure |
Care as Usual
n=116 Participants
care as usual, no intervention, just observation of natural change/ trajectories over time
|
Implementation of Dementia Care Manager
n=291 Participants
Subjects in this arm will be provided with a specialised "Dementia Care Manager" to be included in a subsidiary support system
Implementation of Dementia Care Manager: Home-visits of trained "Dementia Care Manager (DCM)" at least monthly for 6 months. The DCM will, in close cooperation with the general practitioner, establish and include a subsidiary support system for subjects and their caregivers.
|
|---|---|---|
|
Change in Quality of Life
|
2.8 units on a scale
Standard Deviation 0.3
|
2.8 units on a scale
Standard Deviation 0.4
|
PRIMARY outcome
Timeframe: one year after baseline assessmentCaregiver burden was assessed using the "Berliner Inventar zur Angehörigenbelastung - Demenz" (BIZA-D) (Zank et al., 2006). The BIZAD was developed to assess objective as well as subjective burden due to caring for a person wit dementia (PWD). It consists of 88 items covering 20 dimensions of caregiver burden. Objective burden is divided into six dimensions: 1) basic care tasks like support eating, hygiene etc (7 items), 2) extended care tasks like supporting grocery shopping, legal affairs etc. (3 items), 3) Motivation and Guidance (4 items), 4) emotional support (4 items), 5) supporting maintenance of social contacts (3 items) and 6) supervision (4 items). Each item has to be rated regarding the frequency of the support needed on a 5-Point scale (example: supervision; Does the patient need this kind of support: 1=always, 2= mostly, 3=partly, 4=hardly, 5= not at all). Then each item asks: Who is providing this support: all by someone else, mostly by someone else, evenly distributed
Outcome measures
| Measure |
Care as Usual
n=116 Participants
care as usual, no intervention, just observation of natural change/ trajectories over time
|
Implementation of Dementia Care Manager
n=291 Participants
Subjects in this arm will be provided with a specialised "Dementia Care Manager" to be included in a subsidiary support system
Implementation of Dementia Care Manager: Home-visits of trained "Dementia Care Manager (DCM)" at least monthly for 6 months. The DCM will, in close cooperation with the general practitioner, establish and include a subsidiary support system for subjects and their caregivers.
|
|---|---|---|
|
Change in Caregiver Burden
|
0.4 units on a scale
Standard Deviation 2.62
|
0.13 units on a scale
Standard Deviation 2.63
|
PRIMARY outcome
Timeframe: one year after baseline assessmentNeuropsychiatric Inventory (NPI; Cummings 1997); The NPI represents an interview by proxy on twelve dimensions of neuropsychiatric behaviors, i.e. delusions, hallucinations, agitation, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor behavior, night-time behavior disturbances, and appetite and eating abnormalities. The presence (0= no, 1= yes) is asked. If present, the severity (rated 1 through 3; mild to severe) and frequency (1 to 4, rarely to very often) of each neuropsychiatric symptom are rated on. Thus the score for each dimension ranges from 0 = not present, 1= mildly and rarely to 12 = severe and often. A total NPI score is calculated as the sum of the frequency by severity scores ofeach domain range: 0 to 144, the higher the more neuropsychiatric symptomatic).
Outcome measures
| Measure |
Care as Usual
n=116 Participants
care as usual, no intervention, just observation of natural change/ trajectories over time
|
Implementation of Dementia Care Manager
n=291 Participants
Subjects in this arm will be provided with a specialised "Dementia Care Manager" to be included in a subsidiary support system
Implementation of Dementia Care Manager: Home-visits of trained "Dementia Care Manager (DCM)" at least monthly for 6 months. The DCM will, in close cooperation with the general practitioner, establish and include a subsidiary support system for subjects and their caregivers.
|
|---|---|---|
|
Change in Behavioral and Psychological Symptoms of Dementia
|
15.2 units on a scale
Standard Deviation 16.9
|
8.2 units on a scale
Standard Deviation 13.6
|
PRIMARY outcome
Timeframe: one year after baseline assessmentmedication was systematically reviewed; A computer-based home medication review (HMR) encompasses all medications used by the study participants and includes questions about compliance, adverse effects and drug administration. The collection of primary data on medication in the context of the HMR includes both prescription drugs and over-the-counter drugs. The assignment was then integrated using a master file of the Pharmaceutical Index. The following antidementia drugs were considered: donepezil (N06AD02), rivastigmine (N06AD03), galantamine (N06AD04) and memantine (N06AX01).
Outcome measures
| Measure |
Care as Usual
n=116 Participants
care as usual, no intervention, just observation of natural change/ trajectories over time
|
Implementation of Dementia Care Manager
n=291 Participants
Subjects in this arm will be provided with a specialised "Dementia Care Manager" to be included in a subsidiary support system
Implementation of Dementia Care Manager: Home-visits of trained "Dementia Care Manager (DCM)" at least monthly for 6 months. The DCM will, in close cooperation with the general practitioner, establish and include a subsidiary support system for subjects and their caregivers.
|
|---|---|---|
|
Change in Medical Treatment With Antidementia Drugs
|
31 participants
|
114 participants
|
PRIMARY outcome
Timeframe: one year after baseline assessmentHaving to deal with multimorbidity and polypharmacy in a sample of chronically ill elderly, we also analyze potentially inappropriate medication (PIM), defined as "a drug for which the risk of an adverse event outweighs the clinical benefit, particularly when there is evidence in favor of a safer or more effective alternative therapy for the same condition". The PIM were identified using the Priscus list, which contains 83 drugs from 18 different drug classes.
Outcome measures
| Measure |
Care as Usual
n=116 Participants
care as usual, no intervention, just observation of natural change/ trajectories over time
|
Implementation of Dementia Care Manager
n=291 Participants
Subjects in this arm will be provided with a specialised "Dementia Care Manager" to be included in a subsidiary support system
Implementation of Dementia Care Manager: Home-visits of trained "Dementia Care Manager (DCM)" at least monthly for 6 months. The DCM will, in close cooperation with the general practitioner, establish and include a subsidiary support system for subjects and their caregivers.
|
|---|---|---|
|
Reduction of Potential Inapropriate Medication (PIM)
|
19 Participants
|
77 Participants
|
SECONDARY outcome
Timeframe: one year after baseline assessmentThe functional status was assessed using the Bayer Activities of Daily Living Scale (B-ADL). It coonsits of 25 Items indicating everyday problems/ challenges. Their occurence is rated on a scale of 1 "never", to 10 "always". All ratings are added and divided by the number of items. This yields a mean score of 1 to 10, where 1 indicates the lowest possible impairment and 10 indicates the highest possible impairment.
Outcome measures
| Measure |
Care as Usual
n=116 Participants
care as usual, no intervention, just observation of natural change/ trajectories over time
|
Implementation of Dementia Care Manager
n=291 Participants
Subjects in this arm will be provided with a specialised "Dementia Care Manager" to be included in a subsidiary support system
Implementation of Dementia Care Manager: Home-visits of trained "Dementia Care Manager (DCM)" at least monthly for 6 months. The DCM will, in close cooperation with the general practitioner, establish and include a subsidiary support system for subjects and their caregivers.
|
|---|---|---|
|
Person With Dementia: Change in Activities of Daily Living
|
4.4 units on a scale
Standard Deviation 2.4
|
4.9 units on a scale
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: participants will be followed yearly until institutionalisation or death after an expected average of 5 yearsThe F-SozU (Fydrich et al. 2007) will be used to assess social support in several domains
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: participants will be followed yearly until institutionalisation or death after an expected average of 5 yearsSeveral instruments will be used to assess the health of the person with dementia: the GP records the Fragebogen zum SF12- health survey (SF-12, Bullinger et al. 1998) the standardized assessment of elderly in primary care (STEP; Sandholzer et al. 2004) the Brief Symptom Inventory (BSI; Derogatis et al. 1983) the Patient´s health questionnaire (PHQ-D; Löwe et al. 2002, Spitzer et al. 1999)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: participants will be followed yearly until institutionalisation or death after an expected average of 5 yearsfrequency of utilisation of 1. general physicians and physicians of other specialties 2. out-patient treatments 3. in-patient treatments 4. hospitalisations 5. institutionalisation 6. therapeutic appliances standardised assessment with the Resource Utilization in Dementia (RUD, Wimo et al. 1998).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: participants will be followed yearly until institutionalisation or death after an expected average of 5 yearsThe DCM will conduct an IT-supported home medication review (Fiss et al., 2010) at the patients home with subsequent medication management by the local pharmacy regarding frequency of drug related problems, intake of PIM, clinically relevant drug-drug interaction, adherence, utilisation of adherence supporting activities (medication plan, drug dispenser, support by care service, reduction of the number of drugs taken
Outcome measures
Outcome data not reported
Adverse Events
Care as Usual
Implementation of Dementia Care Manager
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
PD Dr. JR Thyrian
Geman Centr for Neurodegenerative Diseases (DZN)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place