A cluster randomised controlled trial of an occupational therapy intervention for residents with stroke living in UK care-homes
Phase 3
Completed
- Conditions
- Stroke rehabilitationCirculatory SystemStroke, not specified as haemorrhage or infarction
- Registration Number
- ISRCTN00757750
- Lead Sponsor
- niversity of Birmingham (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 840
Inclusion Criteria
Adult men and women living in a care home with a history of stroke or transient ischaemic attack (TIA)
Exclusion Criteria
Active end of life care plan
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Independence in activities of daily living, assessed using the Barthel Activity of Daily Living Index, a commonly used measure (toileting, dressing, feeding, continence, mobility and grooming) containing 10 items and scored from 0-20 (with 20 being more independent)<br> <br>All primary and secondary outcome measures will be assessed at baseline (0 months), after the intervention (3 months) and at follow-up (6 and 12 months).
- Secondary Outcome Measures
Name Time Method 1. Rivermead Mobility Index (RMI), a 15 item measure of functional mobility (scored 0-15, 15 being more mobile)<br>2. Mood, assessed by a 15-item Geriatric Depression Scale (GDS15), and informant version<br>3. Adverse events<br>4. Staff attitude<br>5. Health utility will be estimated using the Euroqol EQ-5D <br> <br>All primary and secondary outcome measures will be assessed at baseline (0 months), after the intervention (3 months) and at follow-up (6 and 12 months). <br> <br>In addition, the Mini-Mental State Examination (MMSE) will be used at baseline to determine the level of a resident's cognitive impairment; not as an exclusion criterion.