Objectives and brief methodology
Individually randomised controlled multi-centre study (with internal pilot) 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.
Background:
Frailty is a condition characterised by reduced biological reserves and increased vulnerability to adverse outcomes including falls, disability, hospitalisation and care home admission. It develops as a consequence of an age-related decline in several physiological systems, which collectively results in a vulnerability to sudden health status changes triggered by relatively minor stressor events. The majority of older people (>65 years) in hospital have frailty and are at increased risk of readmission or death following discharge home. Sarcopenia (loss of muscle mass and strength) is a core component of frailty and periods of immobility in older age, such as that experienced during an acute illness or injury, can accelerate loss of skeletal muscle function. Furthermore, the inflammatory response that is commonly associated with acute illness or injury can lead to catabolism of muscle protein for generation of energy and immune proteins, which can further accelerate loss of muscle mass and strength. This is especially problematic in frailty because accelerated loss of skeletal muscle function can compromise the capability to perform activities of daily living (e.g. walking, dressing, toileting, climbing stairs), jeopardising successful functioning in the home environment, which may lead to a requirement for increased home care, or admission to long-term care residence.
Contact with an intermediate care service is recommended as national policy to enhance recovery after hospital admission for an acute illness or injury but people frequently do not feel ready to return home, and are at risk of subsequent readmission. The benefits of rehabilitation in intermediate care are attenuated over time.
Exercise has positive physiological effects on skeletal muscle, the brain/nervous system and the endocrine system. Additionally, observational studies have identified a consistent inverse dose-response relationship between physical activity and inflammation. Systematic reviews of exercise interventions for older people with frailty have reported evidence for improvements in mobility and activities of daily living, but few studies measured effects on quality of life and no studies reported on cost-effectiveness. Exercise programmes based on progressive strength training were important for functional improvement.
In the pilot RCT of the HOPE programme [1] 84 of 474 identified potential participants, community-dwelling frail older people, were recruited and randomised to either the intervention group (the HOPE programme + usual care) or control group (usual care). Feasibility was demonstrated, with potential for a positive clinically important intervention effect on mobility (mean between group difference in timed-up-and-go test (TUGT) 28.6s, 95% CI -8.5 to 65.9s) 14 weeks post-randomisation without adverse outcomes.
Aims & Objectives:
Primary: To establish whether a home-based exercise intervention plus usual care as extended rehabilitation for older people with frailty improves health-related quality of life.
Secondary:
- To establish whether the intervention improves mental health.
- To establish whether the intervention improves activities of daily living.
- To establish whether the intervention reduces hospitalisation rates, care home admission rates, falls and overall health and social care resource use.
- To establish whether the intervention is cost-effective.
- To understand how the intervention is experienced and understood by providers and recipients, and explore the organisational implications of embedding and sustaining the intervention in preparation for wider NHS roll-out.
Methods:
Pragmatic multi-centre individually randomised study with a two level, partially nested hierarchical design, internal pilot with progression criteria and an embedded process evaluation and parallel cost-effectiveness.
Population: Older people (aged >65) with frailty admitted to hospital following acute illness or injury then discharged home directly from hospital or from intermediate care services.
Intervention: 24 week home based exercise intervention (HOPE Programme [1]).
HOPE Programme
The Home-based Older People’s Exercise (HOPE) programme is a home-based exercise intervention for older people with frailty. It is a 12 week graded, progressive exercise intervention aimed at improving strength, endurance and balance that is presented to participants in an exercise manual and delivered by community-based physiotherapists and therapy assistants. Participants will receive weekly support through five face-to-face home visits and seven telephone sessions. The programme will be extended with weekly telephone calls for a further 12 weeks to ensure that participants are well-positioned for ongoing self-management following completion of the intervention.
Timescales
Study period: 01/03/2017 – 31/05/2023
Recruitment of participants from December 2017. Recruitment now closed as at 06/08/2021
Recruitment target: 742
Recruitment at 06/08/2021: 743
Further information
Grant applicants:
Dr Andrew Clegg, Dr David Clarke, Bonnie Cundill, Professor Amanda Farrin, Professor Anne Forster, Dr Vicki Goodwin, Suzanne Hartley, Professor Claire Hulme, Phil Wright, Professor John Young
Collaborators:
Academic Unit of Elderly Care and Rehabilitation, University of Leeds.
Bradford Institute of Health Research, Bradford Royal Infirmary, Bradford Teaching Hospitals NHS Foundation Trust
Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds.
Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds.
University of Exeter Medical School.
For further information please contact Project Lead Dr Andrew Clegg or Trial Manager Matthew Prescott
This summary presents independent research funded by the National Institute for Health and Care Research Health Technology Assessment Programme (NIHR HTA) (Grant Reference Number: 15/43/07). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.
Ethical Approval:
Yorkshire & The Humber – Bradford Leeds Research Ethics Committee (REC Reference 17/YH/0097).
Trial Registry:
ISRCTN Registry: 13927531 https://doi.org/10.1186/ISRCTN13927531
Reference:
- Clegg A, Barber S, Young G, Iliffe S, Forster A. The Home-based Older People’s Exercise (HOPE) trial: a pilot randomised controlled trial of a home-based exercise intervention for older people with frailty. Age and Aging 2014; 43: 687-695. (PDF)
Research outputs
Information for participants
Who is responsible for your data:
The joint data controllers for HERO trial are the sponsor organisation, Bradford Teaching Hospitals NHS Foundation Trust (BTHFT) and the University of Leeds (UoL). This means that both organisations are responsible for how your data is collected, stored, shared and used.
What information do we collect about you:
Staff within the NHS collect information from you and your medical records for this research and send it to the Clinical Trials Research Unit (CTRU) at the University of Leeds. The CTRU will use your name, address, and contact details to contact you about the research study, namely for the purpose of sending questionnaires and providing any study updates.
Your NHS number, gender, initials, date of birth and postcode will be shared with NHS Digital, to obtain information about you from your electronic health care records. We will do this because it is a more efficient way to collect certain data about your health. By using data routinely collected from hospital/health visits, we can reduce the burden (such as the number of researcher contacts) on you and your hospital. When we do this linking, we will only use the data mentioned above to identify you, and we will follow strict rules when working with other organisations to maintain confidentiality and to protect your data. You can read more about NHS Digital here: https://digital.nhs.uk/about-nhs-digital.
The information received from NHS Digital and that from NHS staff will be entered into a database held securely at the Clinical Trials Research Unit.
Individuals from the BTHFT (the study sponsor) and regulatory organisations may look at your medical and research records to make sure the study has been run correctly. The only people at BTHFT and UoL who will have access to information that identifies you are the people involved in study follow-up (e.g. posting questionnaires) or auditing the data. People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead.
How long we keep your data:
Bradford Teaching Hospitals NHS Foundation Trust and the University of Leeds will keep your data for a minimum period of 10 years after the end of the study, after which it will be securely destroyed.
How we protect your data:
We protect your personal data against unauthorised access, unlawful use, accidental loss, corruption or destruction.
We use technical measures such as encryption and password protection to protect your data and the systems they are held in. We also use operational measures to protect the data, for example by limiting the number of people who have access to the databases in which your data is held and using unique reference numbers to identify participants rather than names wherever possible.
We keep these security measures under review and refer to Bradford Teaching Hospitals NHS Foundation Trust and the University of Leeds Information Security Policies to keep up to date with current best practice.
Sharing your data:
Your personal data collected and managed by the University of Leeds will be used to carry out the follow-up of this trial, including linking your personal data with data held by NHS Digital. In order to do this, we will provide your initials, gender, date of birth, NHS number and postcode to NHS Digital. The information we have about you will be linked with the information held by NHS Digital. This will be done in a secure and confidential manner.
It is possible that the information collected about you might be shared with other research teams to answer new research questions in the future. If this happened, the information would be anonymised so that no-one would be able to identify you from it.
Your rights:
Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.
You can find out more about how we use your information:
https://www.hra.nhs.uk/information-about-patients/
https://www.bradfordhospitals.nhs.uk/privacy-statement/
https://ctru.leeds.ac.uk/privacy/
Our legal basis to process your data:
Organisations processing personal data need a legal basis for that processing activity. For public authorities, such as the NHS and Universities, the most appropriate lawful bases when processing personal data and health data (defined as special category data) for the purposes of research are:
Article 6:1(e): Specific task in the ‘public interest’ or task that has a clear basis in law, and
Article 9:2(j): Special category data used for “Archiving in the public interest, scientific or historical research or statistical purposes”, with a basis in law.
To ensure we carry out the research to the highest standards we comply with the UK Policy Framework for Health and Social Care Research. You can learn more about research standards here: https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/uk-policy-framework-health-social-care-research/
Complaints:
If you wish to raise a complaint on how we have handled your personal data, you can contact the Data Protection Officer who will investigate the matter.
University of Leeds Data Protection Officer
• Phone +44 (0) 113 2431751
• Email: dpo@leeds.ac.uk
If you are not satisfied with our response or believe we are processing your personal data in a way that is not lawful you can complain to the Information Commissioner’s Office (ICO) by visiting https://ico.org.uk/make-a-complaint/ or by calling their helpline on 0303 123 1113.
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