A trial to evaluate an extended rehabilitation service for stroke patients (EXTRAS) Study Protocol Version 5: 24 September 2014 Study Funder: Study Sponsor: Health Technology Assessment Programme Northumbria Healthcare NHS Foundation Trust National Institute for Health Research Research and Development Department Alpha House North Tyneside General Hospital University of Southampton Science Park Rake Lane Southampton North Shields SO16 7NS NE29 8NH Chief Investigator: Professor Helen Rodgers Professor of Stroke Care Stroke Research Group Institute for Neuroscience Newcastle University 3-4 Claremont Terrace Newcastle upon Tyne NE2 4AE EXTRAS protocol v5: 24 September 2014 Page 1 of 28 Contents Protocol contacts .................................................................................................................................... 3 Grant award holders ............................................................................................................................... 4 Protocol signature page .......................................................................................................................... 5 Glossary .................................................................................................................................................. 6 Protocol summary ................................................................................................................................... 7 Background............................................................................................................................................. 8 Study aim and objectives ........................................................................................................................ 9 Study design ......................................................................................................................................... 10 Study setting ......................................................................................................................................... 10 Study participants ................................................................................................................................. 11 Case ascertainment, recruitment and consent ....................................................................................... 11 Recruitment assessment ........................................................................................................................ 13 Baseline assessment .............................................................................................................................. 13 Randomisation ...................................................................................................................................... 13 Study control treatment ........................................................................................................................ 14 Study intervention treatment ................................................................................................................ 14 Outcome assessments ........................................................................................................................... 15 Blinding ................................................................................................................................................ 16 Study withdrawal .................................................................................................................................. 16 Safety evaluation .................................................................................................................................. 16 Statistical analysis ................................................................................................................................ 18 Economic analysis ................................................................................................................................ 18 Parallel process evaluation ................................................................................................................... 19 Pilot study ............................................................................................................................................. 20 Ethics and regulatory issues ................................................................................................................. 20 Confidentiality ...................................................................................................................................... 20 Trial monitoring, quality control and quality assurance ....................................................................... 21 Funding ................................................................................................................................................. 21 Indemnity .............................................................................................................................................. 21 Dissemination of results ....................................................................................................................... 22 Trial summary ...................................................................................................................................... 23 References ............................................................................................................................................ 24 Appendix 1: Summary of study schedule ............................................................................................. 27 Appendix 2: Project Gantt chart ........................................................................................................... 28 EXTRAS protocol v5: 24 September 2014 Page 2 of 28 Protocol contacts Chief Investigator: Name: Professor Helen Rodgers Professor of Stroke Care Address: Stroke Research Group Newcastle University 3 – 4 Claremont Terrace Newcastle upon Tyne NE2 4AE Phone: 0191 208 8025 Email: [email protected] Project Manager: Name: Dr Lisa Shaw Senior Research Associate Address: Stroke Research Group Newcastle University 3 – 4 Claremont Terrace Newcastle upon Tyne NE2 4AE Phone: 0191 208 3826 Email: [email protected] Project Administrator: Name: Miss Anne Harrison Project Administrator Address: Stroke Research Group Newcastle University 3 – 4 Claremont Terrace Newcastle upon Tyne NE2 4AE Phone: 0191 208 3853 Email: [email protected] Contact for study sponsor: Name: Ms Caroline Potts Research and Development Manager Address: Research and Development Department Northumbria Healthcare NHS Foundation Trust North Tyneside General Hospital Rake Lane North Shields NE29 8NH Phone: 0844 811 8111 ext 2842 Email: [email protected] EXTRAS protocol v5: 24 September 2014 Page 3 of 28 Grant award holders Lead investigator: Professor Helen Rodgers, Professor of Stroke Care, Institute of Neuroscience, Newcastle University, 3-4 Claremont Terrace, Newcastle NE2 4AE. Email: [email protected]. Co-investigators: Mr Robin Cant, Lay Member, Stroke Research Network Rehabilitation Clinical Studies Group. Email: [email protected]. Dr Mark Deverill, Senior Lecturer, Institute of Health and Society, Newcastle University, Baddiley-Clark Building, Richardson Road, Newcastle NE2 4AX. Email: [email protected]. Professor Avril Drummond, Associate Professor and Reader in Rehabilitation, Division of Rehabilitation and Ageing, University of Nottingham, B Floor, Medical School, Queen’s Medical Centre, Nottingham NG7 2UH. Email: [email protected]. Professor Gary Ford, Chief Executive Officer, Oxford Academic Health Science Network, John Eccles House, Robert Robinson Avenue, Oxford Science Business Park OX4 4GP. Email: [email protected] . Professor Anne Forster, Professor of Stroke Rehabilitation, Academic Unit of Elderly Care and Rehabilitation, University of Leeds, Bradford Institute for Health, Bradford Royal Infirmary, Duckworth Lane, Bradford BD9 6RJ. Email: [email protected]. Ms Denise Howel, Senior Lecturer, Institute of Health and Society, Newcastle University, Baddiley-Clark Building, Richardson Road, Newcastle NE2 4AX. Email: [email protected]. Ms Anne-Marie Laverty, Director of Patient Experience, Stroke Northumbria, Northumbria Healthcare NHS Foundation Trust, Ward 9, Wansbeck General Hospital, Woodhorn Lane, Ashington, Northumberland, NE63 9JJ. Email: [email protected]. Dr Christopher McKevitt, Reader in Social Science and Health, Department of Public Health Sciences, King’s College London, Capital House, 7th Floor, 41 Western Street, London SE1 3QD. Email: [email protected]. Dr Peter McMeekin, Research Associate, Institute of Health and Society, Newcastle University, Baddiley- Clark Building, Richardson Road, Newcastle NE2 4AX. Email: [email protected]. Dr Christopher Price, Clinical Senior Lecturer in Medicine, Stroke Northumbria, Northumbria Healthcare NHS Foundation Trust, Wansbeck General Hospital, Woodhorn Lane, Ashington, Northumberland, NE63 9JJ. Email: [email protected]. Dr Lisa Shaw, Senior Research Associate, Institute of Neuroscience, Newcastle University, 3-4 Claremont Terrace, Newcastle NE2 4AE. Email: [email protected]. EXTRAS protocol v5: 24 September 2014 Page 4 of 28 Protocol signature page Protocol authorisation signatories: Name…………………………Signature ……………………………… Date ………… Chief Investigator Name…………………………Signature