TOTAL 2001

Methods	Randomised controlled trial. Centralised randomisation by telephone. Randomisation stratified by participating centre and a five‐level composite measure of prognosis. Treatment allocation concealed (masking to individual allocation maintained until all outcome measures recorded). Six and 12 month outcome measures obtained by postal questionnaire. Blinded outcome assessment.
Participants	UK 466 patients: 309 intervention (153 patients in Leisure group; 156 patients in ADL group), 157 control. Median age (3 groups): 72 yrs, 71 yrs, 72 yrs. Median Barthel Index score at baseline: leisure 18 (IQR 15 to 19); ADL group 18 (IQR 16 to 20); control group 18 (IQR 16 to 19). 58% male. WHO definition of stroke. Patients recruited from one of four participating sites at discharge and, all patients attending a stroke outcome clinic (site 5, Glasgow) with stroke onset less than six months. Exclusion criteria: discharge to a nursing or residential home; recorded history of dementia; inability to complete outcome questionnaires because of limited use of English language; unable to endure interventions because of co‐existing health conditions; lived outside the catchment area.
Interventions	Occupational therapy leisure 'leisure intervention' versus 'activities of daily living' versus no occupational therapy for a period of up to six months after recruitment to the study. A minimum of 10 treatment sessions lasting not less than 30 minutes were provided to each patient. Leisure group: goals were set in terms of leisure activities as well as ADL tasks to achieve leisure objectives. ADL group: goals set to improve independence in self care activities and included practice in activities such as meal preparation and walking outdoors. Control group: no occupational therapy. Occupational therapy provided by a qualified occupational therapist.
Outcomes	Outcomes were recorded at 6 (primary) and 12 months. Primary outcome measure: General Health Questionnaire 12 item; Nottingham Leisure questionnaire; Nottingham Extended ADL Index. Secondary outcomes: The International Stroke Trial outcome questions; The Rankin Scale; The Oxford Handicap Scale; Barthel Index; The London Handicap Scale. Carer: General Health Questionnaire 12.
Notes	Follow‐up period used in analyses: 12 months.
Risk of bias
Item	Authors' judgement	Description
Allocation concealment?	Yes	A ‐ Adequate

ADL: activities of daily living IQR: inter quartile range OT: occupational therapy SD: standard deviation yrs: years