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van CCT (UK)

van CCT (UK)

Family Meetings in Memory Clinics

- candidate number2640
- NTR NumberNTR1007
- Date ISRCTN created23-aug-2007
- date ISRCTN requested13-aug-2007
- Date Registered NTR27-jun-2007
- Secondary IDs 
- Public TitleFamily Meetings in Memory Clinics
- Scientific TitleFamily Meetings in Memory clinics: Indicated Prevention of developing Anxiety and Depressive Disorders in primary informal caregivers of demented patients
- hypothesisAffective disorders (i.e. depressive or anxiety disorders) of dementia caregivers are largely preventable.
- Healt Condition(s) or Problem(s) studiedDementia, Psycho-social intervention, Informal care-givers, Family meetings
- Inclusion criteria1. 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 criteria1. 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 receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- group[default]
- Type-
- Studytypeintervention
- planned startdate 1-sep-2007
- planned closingdate1-mrt-2012
- Target number of participants172
- InterventionsIntervention 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 outcome1. 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 outcomeCaregiver 1. Caregiver Burden. 2. Quality of life Additional psychological questionnaires are used to explore profiles of caregivers who are best helped by the intervention Patients 1. Depressive symptoms in patients (NPI) 2. Quality of life Other: 1. (in)direct costs caregiver and patient 2. time until institutionalization
- Timepoints
- Trial web site
- statusplanned
- Sponsor/Initiator VU University Medical Center, EMGO+ Institute
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryThe 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)
- RECORD27-jun-2007 - 27-aug-2007

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