|- candidate number||2640|
|- NTR Number||NTR1007|
|- Date ISRCTN created||23-aug-2007|
|- date ISRCTN requested||13-aug-2007|
|- Date Registered NTR||27-jun-2007|
|- Secondary IDs|| |
|- Public Title||Family Meetings in Memory Clinics|
|- Scientific Title||Family Meetings in Memory clinics: Indicated Prevention of developing Anxiety and Depressive Disorders in primary informal caregivers of demented patients|
|- hypothesis||Affective disorders (i.e. depressive or anxiety disorders) of dementia caregivers are largely preventable.|
|- Healt Condition(s) or Problem(s) studied||Dementia, Psycho-social intervention, Informal care-givers, Family meetings|
|- Inclusion criteria||1. Family caregiver who takes primary responsibility for the informal care of a community dwelling patient with a clinical diagnosis of dementia and who lives in the same region as the patient. We only include spouses, children (-in-law), brothers and sisters of the patient.
2. In each family, at least one other family member lives in the same region of the patient and caregiver.
3. Both caregiver and patient have sufficient language proficiency in Dutch for adequate participation in meetings, interviews and tests.
4. Written informed consent from both patient and caregiver is obtained. In case of mental incompetence of a patient the family caregiver will sign the consent for the patient.
|- Exclusion criteria||1. Severe somatic or psychiatric co-morbidity of either caregiver or patient, which will significantly impair cooperation to the program.
2. Either caregiver or patient participates in other intervention studies at inclusion or during the study.
3. Scheduled to move a patient to a nursing home.
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||1-sep-2007|
|- planned closingdate||1-mrt-2012|
|- Target number of participants||172|
|- Interventions||Intervention group:
Primary caregivers of a community dwelling dementia patient and their family and close friends will receive four family meetings during a year. A trained counsellor will run the meetings according to a manual. The aim is to offer psycho-education, increase problem-solving skills and mobilize the naturally existing social network of patient by sharing support tasks of network members.
Usual care group:
Patients and their caregiver will receive the usual care given by the participating memory clinic.|
|- Primary outcome||1. Incidence of major depression and anxiety disorders (i.e. generalised anxiety and panic) as defined according to DSM-IV criteria.
2. Dimension/severity of anxiety and depression symptoms.
|- Secondary outcome||Caregiver
1. Caregiver Burden.
2. Quality of life
Additional psychological questionnaires are used to explore profiles of caregivers who are best helped by the intervention
1. Depressive symptoms in patients (NPI)
2. Quality of life
1. (in)direct costs caregiver and patient
2. time until institutionalization
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Karlijn Joling|
|- CONTACT for SCIENTIFIC QUERIES||PhD. Hein Hout, van|
|- 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||The growing group of family caregivers of dementia patients has a highly increased risk of developing depressive and anxiety disorders. An American landmark study reported substantial beneficial effects of family meetings on depression in family caregivers as well as on delay of institutionalisation of patients. These effects were not replicated in other countries yet. We perform the first trial comparing only structured family meetings with significant others versus usual care among primary family caregivers of community dwelling demented patients and measure the effectiveness on both depression and anxiety, both on disorder and symptom levels.
Four family meetings will be organized with the primary family caregiver of a community dwelling patient with a clinical diagnosis of dementia, family and close friends. Dyads of patients and their primary caregiver are followed up to two years after baseline assessment. The main outcome measure of the effect evaluation is the incidence of anxiety and depressive disorders assessed with the Mini-International Neuropsychiatric Interview (MINI) added with the time of onset in case of a disorder. The severity of anxiety and depressive symptoms is measured by validated self report instruments: the Centre for Epidemiologic Studies Depression Scale (CES-D) and Geriatric Depression Scale (GDS-5) for depression and the anxiety scales of the Hospital Anxiety and Depression scales (HADS) for anxiety. The economic evaluation is performed from a societal perspective.
|- Main changes (audit trail)|
|- RECORD||27-jun-2007 - 27-aug-2007|