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  • Telephone health coaching with exercise monitoring using wearable activity trackers (TeGeCoach) for improving walking impairment in peripheral artery disease: study protocol for a randomised controlled trial and economic evaluation

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Health services research
Protocol
Telephone health coaching with exercise monitoring using wearable activity trackers (TeGeCoach) for improving walking impairment in peripheral artery disease: study protocol for a randomised controlled trial and economic evaluation
  1. Farhad Rezvani1,
  2. Dirk Heider2,
  3. Martin Härter1,
  4. Hans-Helmut König2,
  5. Frank Bienert3,
  6. Julia Brinkmann3,
  7. Lutz Herbarth3,
  8. Edith Kramer3,
  9. Patrick Steinisch3,
  10. Frank Freudenstein3,
  11. René Terhalle3,
  12. Yvonne Grosse3,
  13. Susanne Bock3,
  14. Jacqueline Posselt3,
  15. Corinna Beutel3,
  16. Franziska Reif3,
  17. Florian Kirchhoff4,
  18. Carolin Neuschwander4,
  19. Franziska Löffler4,
  20. Lisa Brunner4,
  21. Patrick Dickmeis5,
  22. Thomas Heidenthal5,
  23. Lara Schmitz6,
  24. Daniela Patricia Chase6,
  25. Claudia Seelenmeyer7,
  26. Mark Dominik Alscher7,
  27. Uwe Tegtbur8,
  28. Jörg Dirmaier1
  1. 1Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Hamburg, Germany
  2. 2Department of Health Economics and Health Services Research, University Medical Center Hamburg-Eppendorf, Hamburg, Hamburg, Germany
  3. 3Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany
  4. 4mhplus Krankenkasse, Nürnberg, Bayern, Germany
  5. 5IEM GmbH, Stolberg, Nordrhein-Westfalen, Germany
  6. 6Philips Germany GmbH, Hamburg, Hamburg, Germany
  7. 7Dr Margarete Fischer Bosch Institute of Clinical Pharmacology, Stuttgart, Baden-Württemberg, Germany
  8. 8Department of Sports Medicine, Hannover Medical School, Hannover, Niedersachsen, Germany
  1. Correspondence to Farhad Rezvani; f.rezvani{at}uke.de

Abstract

Introduction Peripheral artery disease (PAD) is the third most prevalent cardiovascular disease worldwide, with smoking and diabetes being the strongest risk factors. The most prominent symptom is leg pain while walking, known as intermittent claudication. To improve mobility, first-line treatment for intermittent claudication is supervised exercise programmes, but these remain largely unavailable and economically impractical, which has led to the development of structured home-based exercise programmes. This trial aims to determine the effectiveness and cost advantage of TeGeCoach, a 12-month long home-based exercise programme, compared with usual care of PAD. It is hypothesised that TeGeCoach improves walking impairment and lowers the need of health care resources that are spent on patients with PAD.

Methods and analysis The investigators conduct a prospective, pragmatic randomised controlled clinical trial in a health insurance setting. 1760 patients diagnosed with PAD at Fontaine stage II are randomly assigned to either TeGeCoach or care-as-usual. TeGeCoach consists of telemonitored intermittent walking exercise with medical supervision by a physician and telephone health coaching. Participants allocated to the usual care group receive information leaflets and can access supervised exercise programmes, physical therapy and a variety of programmes for promoting a healthy lifestyle. The primary outcome is patient reported walking ability based on the Walking Impairment Questionnaire. Secondary outcome measures include quality of life, health literacy and health behaviour. Claims data are used to collect total health care costs, healthcare resource use and (severe) adverse events. Outcomes are measured at baseline, 12 and 24 months.

Ethics and dissemination Ethical approval has been obtained from the Medical Association Hamburg. Findings are disseminated through peer-reviewed journals, reports to the funding body, conference presentations and media press releases. Data from this trial are made available to the public and researchers upon reasonable request.

NCT03496948 (www.clinicaltrials.gov), Pre-results.

  • health economics
  • health services administration & management
  • clinical trials
  • VASCULAR MEDICINE
  • peripheral artery disease
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2019-032146

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    Footnotes

    • Funding This clinical trial receives funding from the German Innovation Fund (01NVF17013) of the Federal Joint Committee (G-BA), the highest decision-making body of the joint self-government of physicians, dentists, hospitals and health insurance funds in Germany. The use of grant funds is monitored by the German Aerospace Center (Deutsches Zentrum für Luft- und Raumfahrt; DLR). Neither the G-BA nor the DLR is involved in the actual conduct of this work (ie, execution, data analysis, interpretation of data and dissemination).

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Ethics approval Ethical approval has been obtained at the ethics committee of the Medical Association Hamburg (Ärztekammer Hamburg; reference number: PV5708).

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

    • Data availability statement None.