The main objective of this study is to evaluate the effectiveness of a newly developed interdisciplinary tailor-made social fitness programme on the participation in meaningful social activities of community-dwelling older people with dementia and…
ID
Source
Brief title
Condition
- Cognitive and attention disorders and disturbances
- Age related factors
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is patients' and caregivers' participation in
meaningful social activities, assessed with the performance and satisfaction
rating of the Canadian Occupational Performance Measurement (COPM).
Secondary outcome
Secondary outcomes include: patients' and caregivers' quality of life (DQoL)
and health related quality of life (EQ-5D); patients* mobility (TUG),
caregivers* sense of competence (SCQ); resource utilization (RUD-lite) and
socio-demographics. Patients' socio-demographics and frailty (EFIP) are
measured as a covariate.
Background summary
Social exclusion is a common problem among community-dwelling older people with
dementia and their caregivers, and it can result in serious health
consequences. In contrast, social inclusion is one of the four central themes
for good quality of person centred care in dementia in Europe. Studies on
effectiveness of person centred programmes on improving social participation in
meaningful social activities are scarce.
Study objective
The main objective of this study is to evaluate the effectiveness of a newly
developed interdisciplinary tailor-made social fitness programme on the
participation in meaningful social activities of community-dwelling older
people with dementia and their caregivers (dyads). In addition, cost analyses
will be performed.
Study design
A single blind randomised controlled trial with randomisation at individual
dyad level.
Intervention
In the experimental group, patients and their caregivers will receive treatment
and guidance according to the newely developed Social Fitness Programme (SFP).
SFP contains up to two interdisciplinary professional home visits a week during
3 months: an occupational therapist (OT) performs the COTiD-program, a
physiotherapist (PT) performs the Coach2Move protocol and elderly advisors from
a welfare organisation stimulate and guide dyads to participate in social
activities. On demand, this guidance by the elderly advisors is also possible
after 3 months of intervention. Dyads in the control group enrol on a waiting
list. They can receive delayed SFP following their last assessment (after 6
months).
Study burden and risks
Treatment according to the SFP does not entail more risk compared to usual
care. Clients will only be included if they experience problemsn in social
participation and if they have goals they can work on during treatment. Data
show that persons with dementia can be considered good informants of their own
subjective states (Brod et al., 1999). Participants who fulfil inclusion
criteria receive a baseline assessment (to), a measurement after three months
(t1), and a final measurement after six months (t2). Measures are assessed
during home visits, separately with the patient (face to face) and caregiver
(face to face, and using questionnaires). The caregiver can fill in the
questionnaires during the face to face assessments with the patient. The total
expected time of the first (baseline) home visit is 135 minutes: 10 minutes for
the informed consent procedure, 10 minutes to check in- and exclusion criteria
(i.e. MMSE-score if not available), and 75 minutes for the face to face
measures with the patient and 40 minutes for the face to face measures with the
caregiver. It will take the caregiver approximately 35 minutes to fill in the
questionnaires. At t1 and t2 the face to face measures with the patient will
take 45 minutes; the face to face measures with the caregiver will take 10
minutes; and it will take caregivers approximately 30 minutes to fill in the
questionnaires. Resource utilization will additionally be assessed using a ten
minute telephone interview with the caregiver at 1.5 month and 4.5 month after
baseline measurement. The results of the baseline measurement (interview and
questionnaires) are also relevant for the occupational therapist (COPM) and
physiotherapist (EFIP and TUG). After consent these data will become available
to the participating therapists, to minimise the burden of the clients.
Geert Grooteplein 21
Nijmegen 6525 EZ
NL
Geert Grooteplein 21
Nijmegen 6525 EZ
NL
Listed location countries
Age
Inclusion criteria
Home dwelling patient with memory problems (MMSE 10-24);
Who have a caregiver who is available for informal support at a minimum of one time a week.
The patient and caregiver wish to maintain or improve their level of social participation, or to decrease their feelings of loneliness.
Both the patient and the caregiver signed the informed consent form.
Exclusion criteria
1. No goals in total (patient and caregiver together) for social participation, assessed
during the screening interview using the COPM.
2. People who are not capable of completing the self assessment forms (i.e. due to
language problems).
3. Co-morbidity with symptoms that interfere with actively taking part in the intervention (e.g BPSD, severe heart condition).
4. Unstable use (<3 months) of medication which influences cognition
5. Palliative phase of illness
6. Acute illness with hospital indication
7. Current participation in other health research
8. Received physiotherapy according to the Coach2Move protocol in the last 6 months.
9. Received occupational therapy according to the COTiD-programme in the last 6 months.
10. No financial possibilities to receive occupational therapy (i.e. because OT has already been received in the last calendar year).
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 | NL45393.091.13 |