Self-directed rehabilitation randomised controlled trial after stroke: a practical, low cost programme. The Taking Charge after Stroke (TaCAS) Study

All non-Maori, non-Pacific acute stroke patients, likely to be discharged to non-institutional community living, admitted to any hospital in each of the seven DHBs will be approached by a clinician or stroke nurse with information regarding the study. With verbal agreement to participate, contact information will be sent to the researcher(s) responsible for local coordination of recruitment. Trained research assistants/researcher clinicians will contact the person by telephone (at least 3 days after the participant has been discharged home) and arrange a time for an initial visit. The aim is that all initial visits should be conducted within 16 weeks of stroke onset (it is anticipated that in most instances this visit will occur between 3 and 12 weeks from stroke onset). Initial visits should not be conducted in the first week after the potential participant is discharged home or later than 18 weeks from the date of stroke onset. At that visit, written informed consent will be obtained, and if the person is eligible they will be randomised by means of opening consecutively numbered sealed envelopes with random allocation generated from a random dataset by the study biostatistician. All subjects undergo baseline assessment which includes demographic details, pre-stroke dependency, activities of daily living (ADL) (Barthel Index (BI)), instrumental ADL (Frenchay Activities Index (FAI)), mRS, Short Form 12 version 2 Health Survey (SF-12v2), depression (Personal Health Questionnaire [PHQ-2]], Patient Activation Measure (PAM)], blood pressure, heart rate and rhythm, smoking, diabetes, weight, height, medications. Family members can be present, but do not participate in the baseline assessment. Thie assessment will take approximately 30 minutes. Participants will then receive one of: Take charge session This is an individual session with the person alone or with a support person(s). There is no limit to the number of family/support people who can be involved. This is a 50-minute session following a 30 minute baseline assessment designed to engage the patient and their family in the process of recovery, facilitating a process where they identify for themselves areas where they could make progress and set personal goals i.e. self-directed rehabilitation (SDR). The baseline assessment of function and risk factors provides the context for the TCS. The TCS is identical to the TCS delivered in the Maori and Pacific Stroke Study (Harwood M, Weatherall M, Talemaitoga A, Barber PA, Gommans J, Taylor W, McPherson K, McNaughton H. Taking charge after stroke: promoting self-directed rehabilitation to improve quality of life - a randomized controlled trial. Clin Rehabil. 2012;26:493-501). A structured format uses the following main headings: Overall hopes, Main fears, My ‘Best Day’, Physical, Communication, Emotional/Mood, Information needs, Financial, Family, Secondary prevention. The process of describing goals under each heading is explained and where these are forthcoming they are written down. The person and family are encouraged to see this as an ongoing process where they can set new goals and modify existing goals at any time themselves. The person and family are encouraged to consider intermediate steps to the goal and how long it might take to achieve these. Finally they are encouraged to think about ways of making these intermediate steps happen. They are encouraged to ‘take charge’ of the process, having seen for themselves where the key issues are, and given basic skills and supports to write a self-directed rehabilitation plan for themselves (the person with stroke and their family). The intervention is delivered by a research assistant trained to be a facilitator of this process (total length of visit 80 minutes) OR Two take charge sessions For participants randomised to two TCS, the second session will be conducted six weeks after the first (if it is not possible to conduct the session 6 weeks after the first, it may be scheduled for up to but no later than 10 weeks after the first session). This is an individual session with the person alone or with a support person(s). A further structured risk factor and functional assessment will occur, identical to the first session followed by a review of the goals and plan from the first session, and any additional goals. The same general headings will be used to facilitate discussion. A reflective approach to problem-solving will be maintained, including any difficulties achieving goals in the previous 6 weeks. As in the first session, family members/support people are encouraged to be involved. The duration of the second session will be approximately 50 minutes. OR Control Monitoring adherence is straightforward: all participants randomised will attend the first session (as randomisation is part of the first session). Any participants randomised to 2 sessions but who are unable to complete the second session (eg through ill health or death) will be recorded as such. No participant has more than 2 sessions.