CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,982 enrolled
Drug / intervention
TeGeCoachbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03496948
NCT03496948N/ACompleted

PAD-TeGeCoach: Health Coaching and Telemetry Supported Walking Exercise for Improving Quality of Life

Universitätsklinikum Hamburg-Eppendorf·interventional·Posted Apr 12, 2018·Updated Mar 19, 2021

In Brief

A clinical study evaluating TeGeCoach for Peripheral Artery Disease and 6 related conditions. Completed, enrolled 1,982 participants across 3 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedApr 12, 2018
Enrollment StartApr 23, 2018
Primary CompletionFeb 15, 2021
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 8.2 years ago

Interventions

TeGeCoachbehavioral

12-month long telephone health coaching carried out by specially trained coaches. The health coaching is a patient-centered approach based on motivational interviewing, shared decision-making and active listening techniques. Primary care physicians will be constantly involved receiving regular health reports from the coach. The walking exercise is based on the principle of interval training. Patients will continuously wear an activity monitor device to review their exercise performance and for remote exercise monitoring by the coach. This activity information will be regularly reviewed by the coach to ensure that the patient adheres to the individual walking exercise prescription.