Title {1} | Home-based Extended Rehabilitation for Older people (HERO): Individually randomised controlled multi-centre trial to determine the clinical and cost effectiveness of a home-based exercise intervention for older people with frailty as extended rehabilitation following acute illness or injury, including embedded process evaluation (protocol). |
Trial registration {2a and 2b}. | ISRCTN 13927531 (19/04/2017) |
Protocol version {3} | Protocol v5.0 27/01/2020 |
Funding {4} | National Institute for Health Research, Health Technology Assessment Grant: 15/43/07 |
Author details {5a} |
Matthew Prescott1 (Matthew.Prescott@bthft.nhs.uk); Amanda Lilley-Kelly2 (A.C.Lilley-Kelly@leeds.ac.uk); Bonnie Cundill2 (B.E.Cundill@leeds.ac.uk); David Clarke3 (D.J.Clarke@leeds.ac.uk); Sian Drake2 (medsdraa@leeds.ac.uk); Amanda J Farrin2 (A.J.Farrin@leeds.ac.uk); Anne Forster3 (A.Forster@leeds.ac.uk); Madeline Goodwin2 (M.E.L.Goodwin@leeds.ac.uk); Vicki Goodwin4 (V.Goodwin@exeter.ac.uk); Abi Hall4 (A.Hall4@exeter.ac.uk); Suzanne Hartley2 (S.Hartley@leeds.ac.uk); Mike Holland2 (M.Holland@leeds.ac.uk); Claire Hulme4 (C.T.Hulme@exeter.ac.uk); Silviya Nikolova5 (S.K.Nikolova@leeds.ac.uk); Catriona Parker2 (C.A.Parker@leeds.ac.uk); Phil Wright6 (Phil.Wright@bthft.nhs.uk); Friederike Ziegler1 (Friederike.Ziegler@gmail.com); Andrew Clegg3 (A.P.Clegg@leeds.ac.uk). 1Academic Unit for Ageing and Stroke Research, Bradford Institute for Health Research, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, BD9 6RJ 2Clinical Trials Research Unit (CTRU), Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT 3Academic Unit for Ageing and Stroke Research, Leeds Institute of Health Science, University of Leeds, based at: Bradford Institute for Health Research, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, BD9 6RJ 4 College of Medicine and Health, University of Exeter, Exeter, EX1 2 LU 5Academic Unit of Health Economics, University of Leeds, Leeds LS2 9JT 6 Physiotherapy Department, Bradford Teaching Hospitals NHS Foundation Trust, Bradford Royal Infirmary, Bradford, BD9 6RJ |
Name and contact information for the trial sponsor {5b} | Bradford Teaching Hospitals NHS Foundation Trust: Research Management and Support 01274 382575 |
Role of sponsor and funder {5c} |
The Funder has had no role in trial design, beyond setting the research question the trial addresses. As such the trial is designed specifically to address certain aspects of a brief. In designing the trial, the most significant aspect was around the timely implementation of ‘extended rehabilitation’, after the acute/subacute rehabilitation had finished and the individual had been discharged home from the acute or intermediate care setting. Data collection, management, analysis and interpretation will remain independent of the Funder. The Sponsor maintains oversight of trial processes, but is not involved in trial design or delivery processes. The Sponsor will not participate in data analysis or trial reporting processes. |