Family meetings in Memory clinics
| ISRCTN | ISRCTN90163486 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90163486 |
| Secondary identifying numbers | N/A |
- 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
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) |
|---|---|
| k.joling@vumc.nl |
Study information
| Study design | Multicentre, randomised, single-blinded, active controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/09/2007 |
| Completion date | 01/03/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 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
1081 BT
Netherlands
Sponsor information
Vrije University Medical Centre (VUMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
EMGO-Institute
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
| Phone | +31 (0)20 444 8180 |
|---|---|
| emgo@vumc.nl | |
| Website | http://www.vumc.nl/english/ |
"ROR" |
https://ror.org/00q6h8f30 |
Funders
Funder type
Research organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 21/01/2008 | Yes | No | |
| 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 |
