Administrative information
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. |
Introduction
Background and rationale {6a}
Objectives {7}
Internal pilot objectives
Trial design {8}
Methods: participants, interventions and outcomes
Study setting {9}
Site identification and eligibility {10}
Participant identification and eligibility
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Age ≥65 years.
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Admitted to general medicine/elderly medicine or trauma and orthopaedics care following acute illness or injury then discharged home from hospital or from IC.
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Have mild, moderate or severe frailty, defined as a score of five to seven on the nine-item Clinical Frailty Scale (CFS).
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Ability to complete the Timed Up and Go Test (TUGT) without additional external support.
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Ability to give informed consent to participate in the study.
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Permanent care home residents.
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Those with significant cognitive impairment at baseline (defined as Montreal Cognitive Assessment (MoCA) test < 20).
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Recent (< 3 months pre-randomisation) myocardial infarction, or unstable angina.
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Very severe frailty (defined as score of eight on CFS).
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Terminally ill (defined as score of nine on CFS).
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Receiving palliative care.
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Referral at discharge for condition-specific rehabilitation (e.g. pulmonary rehabilitation, stroke rehabilitation, falls prevention programme).
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Another household member in the study.
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Currently participating in the HERO trial or another contraindicated study.
Who will take informed consent? {26a}
Eligibility assessments
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Timed Up and Go Test (TUGT) [24]: measures time (seconds) to stand from a chair, walk 3 metres, turn, and return and sit down on the chair. Developed as a basic mobility test for older people [24], the original TUGT validation study identified that those who complete the test in ≥30 s are likely to require assistance with walking, climbing the stairs and leaving the house.
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Clinical Frailty Scale (CFS) [25, 26]: a well-established ordinal (nine point) measure of frailty that has been validated for use in the hospital setting, with higher scores indicating more severe frailty [25, 26]. Individual categories range from very fit (category 1), to terminal illness (category 9). The CFS is a simple tool that clinical and research staff can routinely use to categorise frailty based on an older person’s pre-admission health. This is in contrast with most performance-based frailty measures (e.g. gait speed, grip strength), which can conflate illness severity or sudden changes in mobility with frailty, so are unsuitable in the context of acute illness or injury.
Changes in capacity
Additional consent provisions for collection and use of participant data and biological specimens {26b}
Interventions
Explanation for the choice of comparators {6b}
Intervention description {11a}
Criteria for discontinuing or modifying allocated interventions {11b}
Strategies to improve adherence to interventions {11c}
Relevant concomitant care permitted or prohibited during the trial {11d}
Provisions for post-trial care {30}
Outcomes {12}
Primary outcome
Secondary outcomes
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PCS score of SF36 measured at 6 months.
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Mental component summary (MCS) score of SF36: alongside mental health, this incorporates elements of vitality and social functioning. It therefore has face validity for capturing additional potential benefits of rehabilitation.
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Barthel Index of activities of daily living [33] assesses functional status on a 20 point scale by recording ability to complete ten basic activities of daily living, including bathing, dressing, toileting, mobility and stairs.
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Nottingham Extended Activities of Daily Living (NEADL) [34] measures help needed with instrumental activities of daily living, including walking around outside, doing the housework, using the telephone.
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EuroQol5-Dimension Health Questionnaire (5 levels) (EQ-5D-5L) [35]: measures health-related quality of life, comprising five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Scores are combined and converted into a summary health utility index (0 for dead, 1 for perfect health and negative values for states worse than death).
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Hospital readmission rates, mortality and hospitalisation due to falls, collected using routine Hospital Episode Statistics (HES) and linked Office for National Statistics (ONS) mortality data.
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Care home admission status, recorded by local research staff, who review address details ahead of postal follow-up, to identify those participants admitted to a care home.
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Healthcare Resource Use. In addition to routine HES data, we will use an adapted version of the Health Resource Use data collection form developed for the NIHR Prevention of Falls Injury Trial (PreFit; https://www.journalslibrary.nihr.ac.uk/projects/081441/#/). The form will include health, informal care, social care and voluntary sector resource.
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Falls questionnaire: participants will record number of falls in the prior 6 months, and any broken bones that resulted.
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Twelve-month usual care review: data collected by site research teams from electronic databases at sites regarding secondary and, if available, primary care service use for participants in the 12 months since randomisation.
Participant timeline {13}
Sample size {14}
Recruitment {15}
Assignment of interventions: allocation
Sequence generation {16a}
Concealment mechanism {16b}
Implementation {16c}
Assignment of interventions: blinding
Who will be blinded {17a}
Procedure for unblinding if needed {17b}
Data collection and management
Plans for assessment and collection of outcomes {18a}
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Charlson Comorbidity Index [40]: a validated measure used to combine the risk from age, and the risk from comorbid disease into a single variable estimating the risk of death. Higher scores indicate greater comorbidity burden.
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Demographic/descriptive data includes: initials, date of birth, gender, NHS number, ethnicity, living arrangements, employment status, details of hospital admission (reason, date of admission and discharge, discharge from setting), any requirement for researcher supported follow-up at 6 and 12 months.
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Carer contact details and demographics: address, telephone number, age, gender, relationship to participant, care responsibilities.
Plans to promote participant retention and complete follow-up {18b}
Data management {19}
Confidentiality {27}
Statistical methods
Statistical methods for primary and secondary outcomes {20a}
Primary analysis
Secondary outcomes
Intervention implementation
Internal pilot
Interim analyses {21b}
Methods for additional analyses (e.g. subgroup analyses) {20b}
Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c}
Plans to give access to the full protocol, participant level-data and statistical code {31c}
Economic evaluation
Process evaluation
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Observe and monitor intervention therapist training, and their engagement with training.
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Engage in informal discussion with therapy teams in early and late stages of intervention delivery to understand how organisational and professional contexts impact on rehabilitation provision to the participant group.
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Interview therapy service managers to establish what constitutes usual care across trial sites.
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Observe home-based delivery of the HOPE programme in a sample of participants across participating sites and across participants with a range of degrees of frailty. Observations will include the interactions between therapists, participants and family members/carers (where present), and note contextual factors potentially influencing programme delivery, receipt and enactment.
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Interview a purposive sample of intervention delivery staff.
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Interview a purposive sample of intervention participants (including those who did and did not engage with the intervention). Carers will also be invited to participate in the semi-structured interviews where it is apparent they have some involvement in supporting participants with the intervention, and/or usual care.
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Interview a purposive sample of trial participants allocated to usual care arm of the trial. This will establish whether they participated in other programmes post discharge provided by the NHS, social care, voluntary or private sector, which may have included similar structured exercise provision, and whether this was evident in particular regions or sites.
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Evaluate intervention adherence using data from participant exercise diaries and therapy records.
Oversight and monitoring
Composition of the coordinating centre and trial steering committee {5d}
Composition of the data monitoring committee, its role and reporting structure {21a}
Adverse event reporting and harms {22}
Frequency and plans for auditing trial conduct {23}
Plans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees) {25}
Dissemination plans {31a}
Discussion
Screening processes
Intervention training
Potential impact of the HERO trial
Trial status
Acknowledgements
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Bradford Teaching Hospitals NHS Foundation Trust
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Leeds Teaching Hospitals NHS Trust
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Royal Devon and Exeter NHS Trust
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Torbay and South Devon NHS Foundation Trust
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Hull University Teaching Hospitals NHS Trust
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Harrogate and District NHS Foundation Trust
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Livewell Southwest
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Sheffield Teaching Hospitals NHS Foundation Trust
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Cornwall Partnership NHS Foundation Trust and Royal Cornwall Hospitals NHS Trust
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North Devon Healthcare NHS Trust
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Somerset NHS Foundation Trust
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Airedale NHS Foundation Trust
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Mid Yorkshire Hospitals NHS Trust
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Dorset Healthcare University NHS Foundation Trust
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Solent NHS Trust