|- candidate number||0|
|- NTR Number||NTR66|
|- Date ISRCTN created||12-sep-2005|
|- date ISRCTN requested||15-aug-2005|
|- Date Registered NTR||31-mei-2005|
|- Secondary IDs||ZonMw-number: 2200.0114 |
|- Public Title||Effectiveness and cost-effectiveness of a care-programme by district nurses among elderly with dementia symptoms and their primary informal caregiver.|
|- Scientific Title||Effectiveness and cost-effectiveness of a care-programme by district nurses among elderly with dementia symptoms and their primary informal caregiver.|
|- ACRONYM||PIKOM (in Dutch: Preventive Intervention among cognitively frail elderly and their caregiver)|
|- hypothesis||Caregivers' sense of competence will improve significantly more in participants of the intervention group compared to the participants in the usual care group.|
|- Healt Condition(s) or Problem(s) studied||Dementia, Dementia symptoms|
|- 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.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||15-jul-2002|
|- planned closingdate||15-jul-2006|
|- Target number of participants||100|
|- Interventions||1. Usual care;|
2. Care programme by district nurses.
|- 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.
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Drs. DaniŽlle Jansen|
|- CONTACT for SCIENTIFIC QUERIES||Drs. DaniŽlle Jansen|
|- Sponsor/Initiator ||VU University Medical Center, EMGO+ Institute|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief 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?
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.
|- Main changes (audit trail)|
|- RECORD||8-aug-2005 - 2-dec-2008|