Title: A trial to evaluate an extended rehabilitation service for stroke patients(EXTRAS)
Funder: Department of Health and Social Care

Abstract: Development of longer term stroke rehabilitation services are limited by lack of evidence of effectiveness for specific interventions and service models. This study will evaluate a new extended stroke rehabilitation service which will commence when Early Supported Discharge (ESD) ends. Study design: Multicentre randomised controlled trial with health economic and process evaluations. Setting: Twelve or more NHS stroke services. Participants: Adults with a new stroke (and carer if appropriate) being discharged from hospital under the care of an ESD team. Study intervention treatment: An extended stroke rehabilitation service provided following completion of ESD. A senior ESD team member will undertake a structured assessment and goal setting focussing upon extended activities of daily living at 1, 3, 6, 12 and 18 months. Assessments will usually be undertaken by telephone. Study control treatment: Usual care post ESD. Usual care may involve referral of patients to a range of rehabilitation services upon completion of ESD in accordance with local clinical practice. Randomisation: Central independent web based service. Primary outcome: Nottingham Extended Activities of Daily Living Scale at 24 months post randomisation. Secondary outcomes: For patients: health status (Oxford Handicap Scale), quality of life (Euroqol EQ-5D), mood (Hospital Anxiety and Depression Scale), experience of services and resource use (adaptation of the Client Service Receipt Inventory) at 12 and 24 months post randomisation. For carers: quality of life (Euroqol EQ-5D), carer stress (Caregiver Strain Index) and experience of services at 12 and 24 months post randomisation. Blinding: Outcomes by blinded assessor. Process evaluation: Semi-structured interviews with a subsample of study participants and staff to gain insight into their perceptions and experience of study treatments. Sample size: Allowing for 25% attrition, 510 participants are needed to provide 90% power to detect a difference in mean Nottingham EADL score of 6 with a 5% significance level.

Lay abstract: One third of patients have long term disability after stoke but specialist stroke rehabilitation usually last no more than a few months. Patients who have on going rehabilitation needs once specialist stroke rehabilitation finishes may be referred to a range of other health care professionals or services, but most do not offer specialist stroke rehabilitation. One of the reasons why specialist stroke rehabilitation is not provided over a longer period is because it is not yet known if it is beneficial. This research project is a clinical trial to determine whether a new extended stroke rehabilitation service is beneficial to patients and carers. Stroke patients and carers who agree to participate in the trial will be randomly allocated to either receive a new extended stroke rehabilitation service or continue with usual NHS care when routine specialist stroke rehabilitation (Early Supported Discharge (ESD)) ends. The extended stroke rehabilitation service will involve on going contact, usually by telephone, with a senior ESD stroke therapist/nurse for 18 months after ESD finishes. The therapist/nurse will contact patients and carers at 1, 3, 6, 12 and 18 months after discharge from ESD to review their progress and rehabilitation needs. Rehabilitation goals will be agreed and the therapist/nurse will give advice on how to progress towards these goals. The advice may be verbal advice, for example, exercises to practice at home. Or, if required, referral to local rehabilitation services may be arranged. The effectiveness of the new extended rehabilitation service will be evaluated by comparing the health (e.g functional abilities and quality of life) of patients and carers who received the new service with those who received usual NHS care. The study will run for 5 years and aims to recruit 510 stroke patients/carers from 12 or more NHS stroke services.

Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: STROKE