Promoting a home-based walking exercise using telephone-based health coaching and activity monitoring for patients with intermittent claudication (TeGeCoach): protocol for a randomized controlled trial

Introduction:

Peripheral artery disease is the third most prevalent cardiovascular disease worldwide, with over 200 million people affected, while smoking and diabetes being the strongest risk factors. The most prominent symptom is leg pain while walking known as intermittent claudication, as the muscles do not get enough blood during exercise to meet the needs. To improve mobility, first line treatment for intermittent claudication are outpatient supervised exercise programs; however, their implementation face manifold challenges: low patient adherence, no reimbursement by insurers, high costs of course implementation, and low course availability. These barriers led to the development of home-based exercise programs, which are similarly effective when combined with a structured approach by setting exercise goals, monitoring exercise activity, and regular follow up with a coach. Therefore, this trial aims to determine the clinical and cost effectiveness of TeGeCoach, a 12-month long structured home-based exercise program, compared to the routine care of intermittent claudication.

Materials & Methods:

A prospective, open-label, multicenter randomized controlled trial to evaluate the effectiveness and safety of TeGeCoach. 4630 patients with peripheral artery disease at Fontaine stage II, identified from three statutory health insurers in Germany, will be randomly assigned either to TeGeCoach or Treatment as Usual (routine care). TeGeCoach consists of a telephone-based health coaching to strengthen health literacy, remote walking exercise monitoring with the use of a wearable activity tracker (telemonitoring), and intensified primary care. Depending on the individual functional status and exercise capacity, participants will be asked to walk up to seven times a week. Primary outcomes are functional capacity measured by the Walking Impairment Questionnaire, alongside with total health care costs based upon routine health insurance data. Secondary outcome measures include quality of life, health literacy and health behavior. Outcomes will be measured at three time points (0, 12, and 24 months). To address dropouts appropriately, an intention-to-treat analysis strategy with multiple imputation of missing values will be employed. Differences between the groups will be identified by means of mixed effects models.

Discussion:

Clearly, the current routine care of intermittent claudication is partly ineffective und insufficient, with the consequence of a poorly served patient population and worsening disease condition. TeGeCoach may provide an effective and feasible alternative in the management of intermittent claudication by improving access to supervised exercise while at the same time potentially reducing health care costs.