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  • Can smartphone technology be used to support an effective home exercise intervention to prevent falls amongst community dwelling older adults?: the TOGETHER feasibility RCT study protocol

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Rehabilitation medicine
Protocol
Can smartphone technology be used to support an effective home exercise intervention to prevent falls amongst community dwelling older adults?: the TOGETHER feasibility RCT study protocol
  1. Helen Hawley-Hague1,
  2. Carlo Tacconi2,3,
  3. Sabato Mellone2,3,4,
  4. Ellen Martinez5,
  5. Angela Easdon6,
  6. Fan Bella Yang7,
  7. Ting-Li Su8,
  8. A Stefanie Mikolaizak9,
  9. Lorenzo Chiari2,3,4,
  10. Jorunn L Helbostad10,
  11. Chris Todd1
  1. 1 Division of Nursing, Midwifery and Social Work, School of Health Sciences, Faculty of Biology, Medicine and Health and Manchester Academic Health Sciences Centre, University of Manchester, Manchester, UK
  2. 2 Health Sciences and Technologies-Interdepartmental Center for Industrial Research, University of Bologna, Bologna, Italy
  3. 3 mHealth Technologies srl, Bologna, Italy
  4. 4 Department of Electrical, Electronic and Information Engineering ‘Guglielmo Marconi’, University of Bologna, Bologna, Italy
  5. 5 Central Manchester University Hospitals NHS Foundation Trust, Manchester, UK
  6. 6 Pennine Care NHS Foundation Trust, Ashton-under-Lyne, UK
  7. 7 Centre for Health Economics, University of York, York, UK
  8. 8 Division of Dentistry, School of Medical Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK
  9. 9 Department of Clinical Gerontology, Robert-Bosch-Krankenhaus, Stuttgart, Germany
  10. 10 Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway
  1. Correspondence to Dr Helen Hawley-Hague; helen.hawley-hague{at}manchester.ac.uk

Abstract

Introduction Falls have major implications for quality of life, independence and cost to the health service. Strength and balance training has been found to be effective in reducing the rate/risk of falls, as long as there is adequate fidelity to the evidence-based programme. Health services are often unable to deliver the evidence-based dose of exercise and older adults do not always sufficiently adhere to their programme to gain full outcomes. Smartphone technology based on behaviour-change theory has been used to support healthy lifestyles, but not falls prevention exercise. This feasibility trial will explore whether smartphone technology can support patients to better adhere to an evidence-based rehabilitation programme and test study procedures/outcome measures.

Methods and analysis A two-arm, pragmatic feasibility randomised controlled trial will be conducted with health services in Manchester, UK. Seventy-two patients aged 50+years eligible for a falls rehabilitation exercise programme from two community services will receive: (1) standard service with a smartphone for outcome measurement only or (2) standard service plus a smartphone including the motivational smartphone app. The primary outcome is feasibility of the intervention, study design and procedures. The secondary outcome is to compare standard outcome measures for falls, function and adherence to instrumented versions collected using smartphone. Outcome measures collected include balance, function, falls, strength, fear of falling, health-related quality of life, resource use and adherence. Outcomes are measured at baseline, 3 and 6-month post-randomisation. Interviews/focus groups with health professionals and participants further explore feasibility of the technology and trial procedures. Primarily analyses will be descriptive.

Ethics and dissemination The study protocol is approved by North West Greater Manchester East Research Ethics Committee (Rec ref:18/NW/0457, 9/07/2018). User groups and patient representatives were consulted to inform trial design, and are involved in study recruitment. Results will be reported at conferences and in peer-reviewed publications. A dissemination event will be held in Manchester to present the results of the trial. The protocol adheres to the recommended Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist.

Trial registration number ISRCTN12830220; Pre-results.

  • Rehabilitation
  • older
  • technology

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/.

https://doi.org/10.1136/bmjopen-2018-028100

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    Footnotes

    • Contributors HH-H leads the research project and its design, managing the trial overall and has led the writing of the protocol. CTa and SM give technical support for the study and have advised on outcomes and the manuscript. JLH, LC, ASM, CTo and SM have provided scientific advice around the design of the study and commented on the manuscript. T-LS and FBY have given advice on statistics and health economic part of design and manuscript. AE and EM have given advice on the operationalisation of the study and commented on the manuscript.

    • Funding Dr Helen Hawley-Hague is funded by a National Institute for Health Research (NIHR) (Postdoctoral Research Fellow) for this research project. This publication presents independent research funded by the NIHR. The views expressed are those of the author(s) and not necessarily those of the National Health Service, the NIHR or the Department of Health and Social Care.

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; externally peer reviewed.