|- candidate number||2370|
|- NTR Number||NTR843|
|- Date ISRCTN created||16-jan-2007|
|- date ISRCTN requested||29-dec-2006|
|- Date Registered NTR||14-dec-2006|
|- Secondary IDs||N/A |
|- Public Title||Efficacy of client-centred occupational therapy in patients with multiple sclerosis: a cluster-randomised trial.|
|- Scientific Title||Efficacy of client-centred occupational therapy in patients with multiple sclerosis: a cluster-randomised trial.|
|- hypothesis||Client-centred occupational therapy according to the Occupational Performance Process Model will be more effective in improving daily functioning and societal participation of patients with multiple sclerosis than usual-care occupational therapy.|
|- Healt Condition(s) or Problem(s) studied||Multiple sclerosis (MS)|
|- Inclusion criteria||1. Diagnosed Multiple Sclerosis;
2. New referral for occupational therapy;
3. Age between 18 and 75 years.|
|- Exclusion criteria||1. Major depression.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||1-jan-2007|
|- planned closingdate||31-dec-2009|
|- Target number of participants||280|
|- Interventions||Experimental intervention: client-centred occupational therapy accoridng to the Occupational Performance Process Model (OPPM)
Control intervention: usual-care occupational therapy|
|- Primary outcome||1. Disability Impact Profile (DIP) questionniare;
2. Impact on Participation and Autonomy (IPA) questionnaire.
At baseline) and after 4 and 8
|- Secondary outcome||1. Evaluation of Client-Centred Process (ECGP) questionnaire;
2. Quality of Care through the patient's eyes (QUOTE-EEE) questionnaire;
3. Canadian Occupational Performance Measure (COPM);
4. 9HPT Dexterity measure;
5. Fatigue (MFIS) questionnaire.
6. Pain (PES) questionnaire;
7. Cognitive functioning (PDQ) questionnaire;
8. Generic Health-related Quality of Life (SF-36) questionnaire.
At baseline) and after 4 and 8
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||MSc I.C.J.M. (Isaline) Eyssen|
|- CONTACT for SCIENTIFIC QUERIES||PhD. M.P.M. (Martijn) Steultjens|
|- Sponsor/Initiator ||VU University Medical Center, Department of Rehabilitation Medicine|
(Source(s) of Monetary or Material Support)
|Stichting MS Research|
|- Brief summary||Occupational therapy (OT) is an integral part of the care for MS patients. Severe functional disability and reduced social participation are commonly experienced by patients with MS. OT is aimed at reducing functional disability and improving social participation, thus resulting in increased autonomy and quality of life of patients.
Currently, there is a movement towards client-centred approach to OT. The theoretical benefit is that therapy is tailored to the patientís needs and will therefore result in a bigger improvement in autonomy and quality of life than regular OT. However, so far this theoretical advantage has not been established in scientific research.
This application describes a cluster-randomised trial investigating the efficacy of client-centred OT based on the Occupational Performance Process Model (OPPM) as compared to usual care OT, in patients with Multiple Sclerosis (MS).
Hospitals and rehabilitation centres which treat MS patients in an outpatient setting will be randomised into the experimental or control group. All therapists within an institution in the experimental group will receive a course in OPPM-based treatment. Subsequently, they will treat MS patients accordingly. Therapists from institutions in the control group will provide usual care. In total, 40 therapists will participate. The first 7 patients per participating OT will be included in the study, resulting in a total study population of 280 patients. Measurements will be taken at baseline, post-treatment and at 8 months follow-up. Outcome assessment will primarily take place at the patient level. Primary outcome measures include
disability, and participation and autonomy. Multi-level analyses will be used to identify patient, therapist and institution characteristics associated with successful client-centred practice.
Keywords: multiple sclerosis, occupational therapy, client-centred practice, disability, participation, autonomy
|- Main changes (audit trail)|
|- RECORD||14-dec-2006 - 19-jan-2007|