N/A
N=634
Intervention Study to Improve Life and Care for People With Dementia and Their Caregivers in Primary Care
Dementia
Bottom Line
View on ClinicalTrials.gov: NCT01401582 ↗Enrolled (actual)
634
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Change in Quality of Life — 2.8; 2.8 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Implementation of Dementia Care Manager (Other)
- Age
- Older Adult · 70+ yrs
- Sex
- All
- Sponsor
- German Center for Neurodegenerative Diseases (DZNE)
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Quality of Life |
2.8; 2.8 | — |
| PRIMARY Change in Caregiver Burden |
0.4; 0.13 | — |
| PRIMARY Change in Behavioral and Psychological Symptoms of Dementia |
15.2; 8.2 | — |
| PRIMARY Change in Medical Treatment With Antidementia Drugs |
31; 114 | — |
| PRIMARY Reduction of Potential Inapropriate Medication (PIM) |
19; 77 | — |
| SECONDARY Person With Dementia: Change in Activities of Daily Living |
4.4; 4.9 | — |
| SECONDARY Person With Dementia: Change in Social Support |
— | — |
| SECONDARY Person With Dementia and Caregiver: Change in Health Status |
— | — |
| SECONDARY Person With Dementia: Change in Utilization of Health Care Resources |
— | — |
| SECONDARY Person With Dementia: Change in Medication |
— | — |
Summary
Caring for people with dementia and treating them is a major challenge for the health care system in Germany. Among the challenges for population-based health care research are (a) identification and early recognition, (b) multimorbidity and (c) the integration of persons with dementia into the health care system. One setting which is identified to meet the challenges is the primary care setting and there especially the general physician. There have been a few interventional studies, which have been restricted to selective samples and have been conducted in inpatient settings.
The purpose of this study is to test the efficacy of implementing a subsidiary support system for persons with dementia living at home. This subsidiary support system is initiated by a Dementia Care Manager (DCM), a nurse with dementia-specific advanced training. The main goals are to improve quality of life and health care of the person with dementia and reduce caregiver´s burden.
The study is a general physician based cluster-randomised controlled intervention trial. A population based sample of general physicians will be asked to participate in a systematic screening trial to identify people with dementia in primary care in Mecklenburg Western Pommerania (MV), a federal state in Germany. Upon identification the people will be asked to participate in the DelpHi-MV study and after having given written informed consent will then be assigned to an intervention and a control group. Identification of people with dementia will be achieved by a short screening questionnaire in the physician's office. An extended in-depth data assessment will be conducted after inclusion into the study and then annually to measure the course of the people's health. Data assessment will be done at the people's homes.
People assigned to the intervention group will receive an intervention provided by "Dementia Care Manager". The Dementia Care Manager is a specialised nurse that is going into the person's home to manage the care of dementia as well as caring for the person's relative/ or carer.
Eligibility Criteria
Inclusion Criteria
- 70+ years
- must be living at home
- screening positive (DEMTECT < 9), indicating dementia
Exclusion Criteria
- medical conditions not allowing testing
Data sourced from ClinicalTrials.gov (NCT01401582). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.