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Multicentred randomised controlled trial of an augmented exercise referral scheme using web-based behavioural support in individuals with metabolic, musculoskeletal and mental health conditions: protocol for the e-coachER trial
  1. Wendy Ingram1,
  2. Douglas Webb1,
  3. Rod S Taylor2,
  4. Nana Anokye3,
  5. Lucy Yardley4,5,
  6. Kate Jolly6,
  7. Nanette Mutrie7,
  8. John L Campbell2,
  9. Sarah Gerard Dean2,
  10. Colin Greaves6,
  11. Mary Steele4,
  12. Jeffrey D Lambert2,
  13. Chloe McAdam7,
  14. Ben Jane8,
  15. Jennie King9,
  16. Ray B Jones1,
  17. Paul Little4,
  18. Anthony Woolf10,
  19. Jo Erwin10,
  20. Nigel Charles2,
  21. Rohini H Terry2,
  22. Adrian H Taylor1
    1. 1Faculty of Medicine and Dentistry, Peninsula Medical School, University of Plymouth, Plymouth, UK
    2. 2University of Exeter Medical School, Exeter, UK
    3. 3Department of Clinical Sciences, Brunel University, London, UK
    4. 4Faculty of Medicine, Southampton University, Southampton, UK
    5. 5Nuffield Department of Primary Care Health Sciences, Oxford University, Oxford, UK
    6. 6School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UK
    7. 7Physical Activity for Health Research Centre, University of Edinburgh, Edinburgh, UK
    8. 8Faculty of Sport and Health, University of St Mark and St John, Plymouth, UK
    9. 9Patient & Public Involvement, Plymouth, UK
    10. 10Department of Rheumatology, Royal Cornwall Hospitals NHS Trust, Truro, UK
    1. Correspondence to Dr Wendy Ingram; wendy.ingram{at}plymouth.ac.uk

    Abstract

    Introduction Physical activity is recommended for improving health among people with common chronic conditions such as obesity, diabetes, hypertension, osteoarthritis and low mood. One approach to promote physical activity is via primary care exercise referral schemes (ERS). However, there is limited support for the effectiveness of ERS for increasing long-term physical activity and additional interventions are needed to help patients overcome barriers to ERS uptake and adherence.

    This study aims to determine whether augmenting usual ERS with web-based behavioural support, based on the LifeGuide platform, will increase long-term physical activity for patients with chronic physical and mental health conditions, and is cost-effective.

    Methods and analysis A multicentre parallel two-group randomised controlled trial with 1:1 individual allocation to usual ERS alone (control) or usual ERS plus web-based behavioural support (intervention) with parallel economic and mixed methods process evaluations. Participants are low active adults with obesity, diabetes, hypertension, osteoarthritis or a history of depression, referred to an ERS from primary care in the UK.

    The primary outcome measure is the number of minutes of moderate-to-vigorous physical activity (MVPA) in ≥10 min bouts measured by accelerometer over 1 week at 12 months.

    We plan to recruit 413 participants, with 88% power at a two-sided alpha of 5%, assuming 20% attrition, to demonstrate a between-group difference of 36–39 min of MVPA per week at 12 months. An improvement of this magnitude represents an important change in physical activity, particularly for inactive participants with chronic conditions.

    Ethics and dissemination Approved by North West Preston NHS Research Ethics Committee (15/NW/0347). Dissemination will include publication of findings for the stated outcomes, parallel process evaluation and economic evaluation in peer-reviewed journals.

    Results will be disseminated to ERS services, primary healthcare providers and trial participants.

    Trial registration number ISRCTN15644451; Pre-results.

    • primary care
    • hypertension
    • general diabetes
    • mental health
    • musculoskeletal disorders

    This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

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    Footnotes

    • Contributors AHT conceived the idea for the study with RST, NM, KJ, LY, NA, JLC, CG, SGD, PL, AW/JE, BJ, JLC and RBJ. AHT, RHT, NM, KJ, LY, NA, JLC, CG, JV, SGD, CM, PL, JE, BJ, JLC, AW, RBJ, WI and DW contributed to the final study design and development of the protocol. AHT, JDL, MS and LY developed the web-support and led PPI testing and feedback with JK. NA developed the health economics plan. SGD developed the process evaluation plan with CG, NC and RHT. RHT provided the statistical plan. All authors critically revised successive drafts of the manuscript and approved the final version.

    • Funding This research has been conducted independently by the University of Plymouth, University of Birmingham, Brunel University London, University of Edinburgh, University of Exeter, University of Southampton, Royal Cornwall Hospitals NHS Trust and University of St Mark and St John. It is funded by the Department of Health (DH) as part of the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme (project number 13/25/20).

    • Disclaimer The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.

    • Competing interests SGD reports personal fees from University College London outside the submitted work. CM reports grants from NIHR during the conduct of the study; grants from ESRC Impact Acceleration Award outside the submitted work; is an employee of the Health Improvement Team (NHS Greater Glasgow & Clyde) who fund and manage the Service Level Agreement for the Exercise Referral Scheme. NM reports grants from various research funders including NIHR during the conduct of the study. LY reports grants from NIHR during the conduct of the study.

    • Patient consent Not required.

    • Ethics approval The original study and subsequent amendments were approved by the NHS Research Ethics Committee North West-Preston (REC reference 15/NW/0347).

    • Provenance and peer review Commissioned bid 13/25 Interventions to enhance engagement in exercise referral schemes.

    • Collaborators Trial Steering Committee Full members: Dr Sharon Simpson, Chair (University of Glasgow); Professor Charlie Foster, Independent Member (University of Oxford then University of Bristol); Dr Mark Kelson, Independent Member (Cardiff University then University of Exeter); Professor John Powell, Independent Member (University of Oxford); Mr Chris Cavanagh, Patient and Public Involvement Representative; Professor Adrian Taylor, Chief Investigator (University of Plymouth) Observers; Professor Rod Taylor, Trial Statistician (University of Exeter); Dr Wendy Ingram, Trial Manager (Peninsula Clinical Trials Unit, University of Plymouth); Mrs Pam Baxter, Sponsor Representative (University of Plymouth) Data Monitoring Committee members; Professor Paul Aveyard (University of Oxford); Dr Anne Haase (University of Bristol); Professor Richard Morris (University of Bristol).

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