|- candidate number||15929|
|- NTR Number||NTR4347|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||23-dec-2013|
|- Secondary IDs||n/a |
|- Public Title||The Social Fitness Study|
|- Scientific Title||What is the effectiveness of a tailor-made social fitness program for community dwelling older people with dementia and their caregivers?|
|- hypothesis||Enrolment in the Social Fitness programme improves participants' performance and satisfaction with meanungful social activities, their quality of life, patientsí mobility, caregiversí sense of competence and a decreases resource utilization. |
|- Healt Condition(s) or Problem(s) studied||Dementia, Memory problems, Informal care-givers, Social participation, Psycho-social intervention, Occupational therapy, Physiotherapy, Wellbeing|
|- 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.
|- Exclusion criteria||1. No goals in total (patient and caregiver together) for social participation.|
2. People who are not capable of completing the self assessment forms.
3. Co-morbidity with symptoms that interfere with actively taking part in the intervention
4. Not stable use (< 3 months on the same dose) of medication which influences
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
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2014|
|- planned closingdate||1-sep-2015|
|- Target number of participants||92|
|- Interventions||In the experimental group, patients and their caregivers will receive treatment and guidance according to the newly develloped 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. Dyads in the control group receive usual care. |
|- 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||patients' and caregivers' quality of life (DQoL) and health related quality of life (EQ-5D); patientsí mobility (TUG), caregiversí sense of competence (SCQ); resource utilization (RUD-lite) and socio-demographics. Patients' frailty is measured as a covariate (EFIP).|
|- Timepoints||Participants who fulfil inclusion criteria receive a baseline assessment (to), a measurement after three months (t1), and a final measurement after six months (t2). |
|- Trial web site||www.sociaalfit.nl|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||MSc Hanneke Donkers|
|- CONTACT for SCIENTIFIC QUERIES||PhD, Senior researcher, project leader Maud Graff|
|- Sponsor/Initiator ||Radboud University Medical Center Nijmegen|
(Source(s) of Monetary or Material Support)
|Radboud University Medical Centre Nijmegen|
|- Brief summary||Rationale: 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.
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 blinded randomised controlled trial with randomisation at individual dyad level.
Study population: 92 community-dwelling older people with (signs of) dementia and their caregivers, with goals to maintain or to improve their social participation or to reduce feelings of loneliness.
Main study parameters/endpoints: 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).
|- Main changes (audit trail)||8-May-2014: |
Eligible participants for this study meet all of the following criteria:
- Home dwelling patients with dementia diagnosis (MMSE ≥10); or home dwelling
patients with memory problems signaled by the referring professional (MMSE 10-24);
or home dwelling patients with memory problems and with high intelligence or high
levels of education resulting in an MMSE-score between 25 and 30, with a primary
caregiversí score of ≥3.6 on the IQCODE-N.
- Who have a caregiver who is available for informal support at a minimum of one time
- The patient and caregiver wish to maintain or improve their level of social
participation, or to decrease their feelings of loneliness.
patients' and caregivers' quality of life (DQoL) and health related quality of life (EQ-5D);
patientsí mobility (TUG), caregiversí sense of competence (SCQ); resource utilization (RUD
4.0) and socio-demographics. Patients' frailty is measured as a covariate (EFIP).
|- RECORD||23-dec-2013 - 1-sep-2017|