NCT03496948: TeGeCoach

Telephone Health Coaching and Remote Exercise Monitoring for Peripheral Artery Disease

Completed NA Last updated 19 March 2021

What this trial tests

NA trial testing TeGeCoach in Peripheral Artery Disease in 1,982 participants. Completed in 15 February 2021.

Timeline

23 April 2018

Primary endpoint
15 February 2021

15 February 2021

Quick facts

Lead sponsor	Universitätsklinikum Hamburg-Eppendorf
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	1,982
Start date	23 April 2018
Primary completion	15 February 2021
Estimated completion	15 February 2021
Sites	3 locations across Germany

Drugs / interventions tested

• TeGeCoach

Conditions studied

• Peripheral Artery Disease — all drugs for Peripheral Artery Disease →
• Atherosclerosis — all drugs for Atherosclerosis →
• Peripheral Arterial Disease — all drugs for Peripheral Arterial Disease →
• Arterial Occlusive Diseases — all drugs for Arterial Occlusive Diseases →

Sponsor

Universitätsklinikum Hamburg-Eppendorf — full company profile →

Who can join

Adults 35 to 80, any sex, with Peripheral Artery Disease or Atherosclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Peripheral artery disease (PAD) is the third most prevalent cardiovascular disease worldwide, with over 200 million people affected. Most prominent symptom is leg pain while walking known as intermittent claudication. Based on the currently existing gaps in the management of intermittent claudication, the objective of the this study is to explore the clinical effectiveness and cost advantage of TeGeCoach, a 12-month long home-based exercise program, compared to usual care. TeGeCoach consists of telephone health coaching, remote walking exercise monitoring based on wearable activity monitors and intensified primary care. It is hypothesized that TeGeCoach will improve functional outcomes and will reduce total health care costs.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Rezvani F, Heider D, Härter M, König HH, et al · · 2020 · cited 7× · PMID 32503866 · DOI 10.1136/bmjopen-2019-032146
2. Effects of walking impairment on mental health burden, health risk behavior and quality of life in patients with intermittent claudication: A cross-sectional path analysis.
   Rezvani F, Pelt M, Härter M, Dirmaier J. · · 2022 · cited 4× · PMID 36048797 · DOI 10.1371/journal.pone.0273747
3. Mobile health technologies to improve walking distance in people with intermittent claudication.
   Elfghi M, Dunne D, Jones J, Gibson I, et al · · 2024 · cited 3× · PMID 38353263 · DOI 10.1002/14651858.cd014717.pub2
4. Telephone Health Coaching and Remote Exercise Monitoring (TeGeCoach) in Peripheral Arterial Occlusive Disease—a Randomized Controlled Trial.
   Rezvani F, Heider D, König HH, Herbarth L, et al · · 2024 · cited 2× · PMID 38269534 · DOI 10.3238/arztebl.m2024.0008
5. The effect of telephone health coaching and remote exercise monitoring for peripheral artery disease (TeGeCoach) on health care cost and utilization: results of a randomized controlled trial.
   Heider D, Rezvani F, Matschinger H, Dirmaier J, et al · · 2024 · cited 1× · PMID 37428355 · DOI 10.1007/s10198-023-01616-4
6. Measuring walking impairment in patients with intermittent claudication: psychometric properties of the Walking Estimated-Limitation Calculated by History (WELCH) questionnaire.
   Rezvani F, Härter M, Dirmaier J. · · 2021 · PMID 34540365 · DOI 10.7717/peerj.12039