Condition category
Mental and Behavioural Disorders
Date applied
23/08/2007
Date assigned
23/08/2007
Last edited
25/09/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Karlijn Joling

ORCID ID

Contact details

Vrije University Medical Centre Amsterdam
EMGO-Institute
Department of General Practice
Amsterdam
1081 BT
Netherlands
+31 (0)20 444 8199/(444 1716 direct)
k.joling@vumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Family Meetings in Memory clinics: indicated prevention of developing anxiety and depressive disorders in primary informal caregivers of demented patients

Acronym

FaMe

Study hypothesis

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

The Medical Ethics Committee of the VU University medical centre in Amsterdam has approved the study on July 18, 2007 (ref: 2007/83)

Study design

Multicentre, randomised, single-blinded, active controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

01/09/2007

Overall trial end date

01/03/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

172

Participant 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

Recruitment start date

01/09/2007

Recruitment end date

01/03/2012

Locations

Countries of recruitment

Netherlands

Trial participating centre

Vrije University Medical Centre Amsterdam
Amsterdam
1081 BT
Netherlands

Sponsor information

Organisation

Vrije University Medical Centre (VUMC) (The Netherlands)

Sponsor details

EMGO-Institute
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
+31 (0)20 444 8180
emgo@vumc.nl

Sponsor type

Hospital/treatment centre

Website

http://www.vumc.nl/english/

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2008 protocol in http://www.ncbi.nlm.nih.gov/pubmed/18208607
2. 2012 anxiety and depression results in http://www.ncbi.nlm.nih.gov/pubmed/22303473
3. 2012 time to nursing home results in http://www.ncbi.nlm.nih.gov/pubmed/22876304
4. 2013 cost-effectiveness results in: http://www.ncbi.nlm.nih.gov/pubmed/24053631

Publication citations

  1. Protocol

    Joling KJ, van Hout HP, Scheltens P, Vernooij-Dassen M, van den Berg B, Bosmans J, Gillissen F, Mittelman M, van Marwijk HW, (Cost)-effectiveness of family meetings on indicated prevention of anxiety and depressive symptoms and disorders of primary family caregivers of patients with dementia: design of a randomized controlled trial., BMC Geriatr, 2008, 8, 2, doi: 10.1186/1471-2318-8-2.

  2. Anxiety and depression results

    Joling KJ, van Marwijk HW, Smit F, van der Horst HE, Scheltens P, van de Ven PM, Mittelman MS, van Hout HP, Does a family meetings intervention prevent depression and anxiety in family caregivers of dementia patients? A randomized trial., PLoS ONE, 2012, 7, 1, e30936, doi: 10.1371/journal.pone.0030936.

  3. Time to nursing home results

    Joling KJ, van Marwijk HW, van der Horst HE, Scheltens P, van de Ven PM, Appels BA, van Hout HP, Effectiveness of family meetings for family caregivers on delaying time to nursing home placement of dementia patients: a randomized trial., PLoS ONE, 2012, 7, 8, e42145, doi: 10.1371/journal.pone.0042145.

  4. Joling KJ, Bosmans JE, van Marwijk HW, van der Horst HE, Scheltens P, Vroomen JL, van Hout HP, The cost-effectiveness of a family meetings intervention to prevent depression and anxiety in family caregivers of patients with dementia: a randomized trial., Trials, 2013, 14, 305, doi: 10.1186/1745-6215-14-305.

Additional files

Editorial Notes