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Telephone Health Coaching and Remote Exercise Monitoring for Peripheral Artery Disease

NCT03496948 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1982

Last updated 2021-03-19

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

TeGeCoach

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.

Sponsors & Collaborators

  • Universitätsklinikum Hamburg-Eppendorf

    lead OTHER

Principal Investigators

  • Jörg Dirmaier, PD Dr. · Universitätsklinikum Hamburg-Eppendorf

  • Frank Bienert · KKH statutory health insurance

  • Lutz Herbarth, Dr. · KKH statutory health insurance

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-23
Primary Completion
2021-02-15
Completion
2021-02-15

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03496948 on ClinicalTrials.gov