OTCH 2012

Trial name or title	A cluster RCT of an occupational therapy intervention for residents with stroke living in UK care homes (OTCH)
Methods	Allocation: cluster RCT will be performed with random allocation at the level of care home using computer‐generated random numbers Blindness: randomisation will be conducted by the Clinical Trials Unit and will be revealed only to the treating occupational therapist. Allocation will be concealed from assessors Duration: intervention will be delivered over a 3‐month period (duration of intervention dependent on therapist's and resident's agreed goals) Setting: care homes within the UK
Participants	Diagnosis: stroke or TIA Target N = 900 (from 90 care homes) Age: adults Gender: males and females Inclusion: adult men and women living in a care home with a history of stroke or TIA Exclusion: active end‐of‐life care plan
Interventions	A targeted course of occupational therapy (targeted repetitive training of ADL, provision of adaptive equipment and minor environmental adaptations and staff training) aimed towards improving independence in personal ADL and mobility. The intervention will be delivered to both the individual resident and the care home staff by an occupational therapist over a period of 3 months Standard care (which does not routinely include provision of occupational therapy)
Outcomes	Primary outcome: independence in ADL (Barthel ADL Index) Secondary outcomes: functional mobility (Rivermead Mobility Index), mood (15‐item Geriatric Depression Scale (GDS15) and informant version), adverse events, staff attitude, quality of life and health utility (using the EuroQol EQ‐5D) All primary and secondary outcome measures will be assessed at baseline (0 months), after the intervention is provided (3 months) and at follow‐up (6 and 12 months) In addition, the MMSE will be used at baseline to determine participants' cognitive impairment, not as an exclusion criterion
Starting date	January 2010
Contact information	Professor Catherine Sackley, C.Sackley@uea.ac.uk
Notes	The study is being funded by the NIHR Health Technology Assessment Programme ‐ HTA (UK)－ and aims to be completed in 2013 Trial registration: ISRCTN00757750

ADL: activities of daily living MMSE: Mini‐Mental State Examination RCT: randomised controlled trial TIA: transient ischaemic attack