Family meetings in Memory clinics

ISRCTN	ISRCTN90163486
DOI	https://doi.org/10.1186/ISRCTN90163486
Protocol serial number	N/A
Sponsor	Vrije University Medical Centre (VUMC) (The Netherlands)
Funder	The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Submission date: 23/08/2007
Registration date: 23/08/2007
Last edited: 25/09/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Karlijn Joling
Scientific

Vrije University Medical Centre Amsterdam
EMGO-Institute
Department of General Practice
Amsterdam
1081 BT
Netherlands

Phone	+31 (0)20 444 8199/(444 1716 direct)
Email	k.joling@vumc.nl

Study information

Primary study design	Interventional
Study design	Multicentre, randomised, single-blinded, active controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Family Meetings in Memory clinics: indicated prevention of developing anxiety and depressive disorders in primary informal caregivers of demented patients
Study acronym	FaMe
Study objectives	Affective disorders (i.e., depressive or anxiety disorders) of dementia caregivers are largely preventable. Summary of Family Meetings in memory clinics (FaMe): 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 organised 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.
Ethics approval(s)	The Medical Ethics Committee of the VU University medical centre in Amsterdam has approved the study on July 18, 2007 (ref: 2007/83)
Health condition(s) or problem(s) studied	Affective disorders (i.e., depressive or anxiety disorders) of dementia caregivers
Intervention	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 mobilise 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.
Intervention type	Other
Primary outcome measure(s)	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 Both primary and secondary outcome measures will be measured at baseline and at 6, 12, 18 and 24 months after baseline
Key secondary outcome measure(s)	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. Patients: 1. Depressive symptoms in patients (Neuropsychiatric Inventory [NPI]) 2. Quality of life Other: 1. (In)-direct costs caregiver and patient 2. Time until institutionalisation Both primary and secondary outcome measures will be measured at baseline and at 6, 12, 18 and 24 months after baseline
Completion date	01/03/2012

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	172
Key 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
Key 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
Date of first enrolment	01/09/2007
Date of final enrolment	01/03/2012

Locations

Countries of recruitment

Netherlands

Study participating centre

Vrije University Medical Centre Amsterdam

Amsterdam
1081 BT
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	anxiety and depression results	01/01/2012		Yes	No
Results article	time to nursing home results	01/01/2012		Yes	No
Results article	cost-effectiveness results	22/09/2013		Yes	No
Protocol article	protocol	21/01/2008		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes