To investigate the effectiveness of family meetings on indicated prevention of anxiety and depressive disorders (DSM IV) and symptom levels of primary family caregivers of patients with dementia. To perform an economic evaluation alongside the trial…
ID
Source
Brief title
Condition
- Other condition
- Psychiatric disorders
- Family issues
Synonym
Health condition
psychische stoornissen: angststoornissen- en symptomen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Incidence of major depression and anxiety disorders (i.e. generalised anxiety
and panic) as defined according to DSM-IV criteria (APA 1994) and assessed with
the Mini International Neuropsychiatric Interview (MINI) (Sheehan 1998). The
MINI is used as 6 month prevalence measure.
- The dimensional or severity measure of anxiety and depression symptoms is
derived by validated self report instruments: the Centre for Epidemiologic
Studies Depression Scale (CES-D) and Geriatric Depression Scale (GDS-5) for
depression, the anxiety subscale of the Hospital Anxiety and Depression Scale
(HADS) for anxiety.
Secondary outcome
Caregiver
- Caregiver Burden with the Caregiver Reaction Assessment (CRA) (Given 1992)
- Sense of competence with the SSCQ (Vernooij-Dassen 2000)
- Quality of Life with the Short Form 12 item version (Ware 1995)
- 'Quality adjusted life years' with the SF6D (SF-12)
Patienten
- Depressive symptoms in patients (NPI)
- Quality of Life (SF-12)
Other
- Time until institutionalization
- Costs
Resource utilization of patient and carer will be measured from a societal
perspective with cost diaries (filled out by the carer) which include both
direct (hospital visits) and indirect costs (travel time) and both within and
outside (loss labour days) the health care (RUD, Wimo 1997)
Background 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. Effects are not replicated in other countries yet. When effective,
family meetings can be an important addition to the current care services in
the Netherlands.
Study objective
To investigate the effectiveness of family meetings on indicated prevention of
anxiety and depressive disorders (DSM IV) and symptom levels of primary family
caregivers of patients with dementia. To perform an economic evaluation
alongside the trial.
Study design
Randomised controlled clinical trial comparing structured family meetings
versus usual care with significant others of 224 primary family caregivers of
community dwelling demented patients recruited in memory clinics with a follow
up of 24 months.
Intervention
Four meetings with family and close friends will be organized and run by a
trained counsellor according to a manual (Mittelman 2003) . 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.
Study burden and risks
The burden of the intervention will be minimal for the dementia patients and
their family caregivers. A possible burden can be created by the number of
questionnaires which have to be filled in/ will be taken to assess the study
parameters. Furthermore, emotional discomfort and family conflicts can exist as
a consequence of participation in the intervention. This possible burden will
be in proportion to the potential value of the research.
Van der Boechorstraat 7
1081 BT Amsterdam
NL
Van der Boechorstraat 7
1081 BT Amsterdam
NL
Listed location countries
Age
Inclusion criteria
- family caregiver takes primary responsibility for the informal care of a patient with a clinical diagnosis of dementia and lives in the same region as the patient.
- In each family, at least one other family member lives in the same region of the patient and caregiver.
- Both caregiver and patient have sufficient language proficiency in Dutch for adequate participation in meetings, interviews and tests.
- 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) Caregiver does have a depressive or anxiety disorder at baseline
3) Either caregiver or patient participates in other intervention studies at inclusion or during the study.
4) Scheduled to move a patient to a nursing home.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL16681.029.07 |