No registrations found.
ID
Source
Brief title
Intervention
Outcome measures
Primary outcome
1. Sense of mastery over the caregiver task as measured with the Sense of Competence Questionnaire (SCQ);
2. Quality of life by means of the MOS 36-item short-form health survey (SF-36);
3. Psychological well-being as determined with the Center for Epidemiologic Studies Depression Scale (CES-D).
Secondary outcome
1. Days until institutionalization of the patient as checked with the GPs;
2. Quality of life of the patient as measured with the Dementia Quality of Life Instrument (DQOL);
3. Days until death of the patient as checked with the GPs;
4. Hospital days of the patient by means of cost diaries.
Background summary
Subject:
Informal caregivers of demented elderly who live at home are often burdened with the caregiver task. Support of caregivers could increase the sense of competence over the caregiver task, increase psychological well-being, decrease medical consumption, and delay nursing home placement. The object of this RCT is to determine effectiveness and cost-effectiveness of an intervention among informal caregivers of elderly with dementia symptoms who live at home.
The main research questions of this RCT are:
1. Is the care-programme more effective than usual care in improving sense of mastery over the caregiver task, quality of life, and psychological well-being of primary informal caregivers?
2. Is the care-programme cost-effective compared to usual care when assessed from a societal perspective?
Design:
The design is a randomized controlled trial with assignment to either usual care or the care-programme among patients with dementia symptoms and their primary informal caregivers. Measurements are at baseline and after 6 and 12 months. Randomization takes place after baseline. The random order is established by an independent person using random number tables. We aspire to include 100 dyads of caregiver and patient.
Study objective
Caregivers' sense of competence will improve significantly more in participants of the intervention group compared to the participants in the usual care group.
Study design
N/A
Intervention
1. Usual care;
2. Care programme by district nurses.
Van der Boechorststraat 7
Daniëlle Jansen
Van der Boechorststraat 7
Amsterdam 1081 BT
The Netherlands
+31 (0)20 4441716
d.jansen@vumc.nl
Van der Boechorststraat 7
Daniëlle Jansen
Van der Boechorststraat 7
Amsterdam 1081 BT
The Netherlands
+31 (0)20 4441716
d.jansen@vumc.nl
Inclusion criteria
Elderly are eligible for trial entry if they are 65 years or over, live outside of institutional settings, suffer from dementia symptoms, and have a primary informal caregiver. Both caregiver and patient should have a good command of the Dutch language. Patients with dementia symptoms are persons with multiple cognitive impairments (i.e. memory impairments, aphasia, apraxia, agnosia, and impairment in executive functioning).
It is assumed that these dementia symptoms lead to significant limitations in social functioning, progressive decline in general functioning.
Exclusion criteria
The following exclusion criteria are applied at baseline:
assistance by an outpatient geriatric team for cognitive problems, terminal illness, participation in other research projects and institutionalization.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL39 |
| NTR-old | NTR66 |
| Other | : ZonMw-number: 2200.0114 |
| ISRCTN | ISRCTN83135728 |