{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T00:00:00Z","timestamp":1792108800559,"version":"4.4.0"},"reference-count":38,"publisher":"BMJ","issue":"12","license":[{"start":{"date-parts":[[2023,12,8]],"date-time":"2023-12-08T00:00:00Z","timestamp":1701993600000},"content-version":"unspecified","delay-in-days":7,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000272","name":"National Institute for Health and Care Research","doi-asserted-by":"publisher","award":["NIHR200731"],"award-info":[{"award-number":["NIHR200731"]}],"id":[{"id":"10.13039\/501100000272","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2023,11,14]]},"published-print":{"date-parts":[[2023,12]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>To assess the feasibility of conducting a pragmatic, multicentre randomised controlled trial (RCT) to test the clinical and cost-effectiveness of an informal caregiver training programme to support the recovery of people following hip fracture surgery.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>Two-arm, multicentre, pragmatic, open, feasibility RCT with embedded qualitative study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting<\/jats:title>\n                    <jats:p>National Health Service (NHS) providers in five English hospitals.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Participants<\/jats:title>\n                    <jats:p>Community-dwelling adults, aged 60 years and over, who undergo hip fracture surgery and their informal caregivers.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Intervention<\/jats:title>\n                    <jats:p>\n                      Usual care: usual NHS care. Experimental: usual NHS care\n                      <jats:italic>plus<\/jats:italic>\n                      a caregiver\u2013patient dyad training programme (HIP HELPER). This programme comprised three, 1 hour, one-to-one training sessions for a patient and caregiver, delivered by a nurse, physiotherapist or occupational therapist in the hospital setting predischarge. After discharge, patients and caregivers were supported through three telephone coaching sessions.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Randomisation and blinding<\/jats:title>\n                    <jats:p>Central randomisation was computer generated (1:1), stratified by hospital and level of patient cognitive impairment. There was no blinding.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Main outcome measures<\/jats:title>\n                    <jats:p>Data collected at baseline and 4 months post randomisation included: screening logs, intervention logs, fidelity checklists, acceptability data and clinical outcomes. Interviews were conducted with a subset of participants and health professionals.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>102 participants were enrolled (51 patients; 51 caregivers). Thirty-nine per cent (515\/1311) of patients screened were eligible. Eleven per cent (56\/515) of eligible patients consented to be randomised. Forty-eight per cent (12\/25) of the intervention group reached compliance to their allocated intervention. There was no evidence of treatment contamination. Qualitative data demonstrated the trial and HIP HELPER programme was acceptable.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The HIP HELPER programme was acceptable to patient\u2013caregiver dyads and health professionals. The COVID-19 pandemic impacting on site\u2019s ability to deliver the research. Modifications are necessary to the design for a viable definitive RCT.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"isrctn\" xlink:href=\"ISRCTN13270387\">ISRCTN13270387<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2023-073611","type":"journal-article","created":{"date-parts":[[2023,12,9]],"date-time":"2023-12-09T13:22:37Z","timestamp":1702128157000},"page":"e073611","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":9,"title":["Hospital-based caregiver intervention for people following hip fracture surgery (HIP HELPER): multicentre randomised controlled feasibility trial with embedded qualitative study in England"],"prefix":"10.1136","volume":"13","clinical-trial-number":[{"clinical-trial-number":"isrctn13270387","registry":"10.18810\/isrctn"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1673-2954","authenticated-orcid":false,"given":"Toby O","family":"Smith","sequence":"first","affiliation":[{"name":"Warwick Medical School, University of Warwick, Coventry, UK"},{"name":"School of Health Sciences, University of East Anglia, Norwich, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Reema","family":"Khoury","sequence":"additional","affiliation":[{"name":"Norwich Medical School, University of East Anglia, Norwich, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4751-8248","authenticated-orcid":false,"given":"Sarah","family":"Hanson","sequence":"additional","affiliation":[{"name":"School of Health Sciences, University of East Anglia, Norwich, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8278-6673","authenticated-orcid":false,"given":"Allie","family":"Welsh","sequence":"additional","affiliation":[{"name":"School of Education, University of East Anglia, Norwich, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kelly","family":"Grant","sequence":"additional","affiliation":[{"name":"Norwich Medical School, University of East Anglia, Norwich, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Allan B","family":"Clark","sequence":"additional","affiliation":[{"name":"Norwich Medical School, University of East Anglia, Norwich, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Polly-Anna","family":"Ashford","sequence":"additional","affiliation":[{"name":"Norwich Medical School, University of East Anglia, Norwich, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6881-6984","authenticated-orcid":false,"given":"Sally","family":"Hopewell","sequence":"additional","affiliation":[{"name":"Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K","family":"Pfeiffer","sequence":"additional","affiliation":[{"name":"Department of Clinical Gerontology and Geriatric Rehabilitation, Robert Bosch Hospital, Stuttgart, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Phillipa","family":"Logan","sequence":"additional","affiliation":[{"name":"School of Medicine, University of Nottingham, Nottingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Crotty","sequence":"additional","affiliation":[{"name":"College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew L","family":"Costa","sequence":"additional","affiliation":[{"name":"Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah","family":"Lamb","sequence":"additional","affiliation":[{"name":"Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK"},{"name":"College of Medicine and Health, University of Exeter, Exeter, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2023,12,9]]},"reference":[{"key":"2025121600412214000_13.12.e073611.1","unstructured":"National Hip Fracture Database . 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Evaluation of the resource utilization and Caregiver time in anti-dementia drug trials - a quantitative battery. In: Wimo A , Karlsson G , J\u00f6nsson B , et al ., eds. The Health Economics of dementia. 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