gms | German Medical Science

Background: Peripheral artery disease is the third most prevalent cardiovascular disease worldwide and has become a serious public health issue, with over 200 million people affected. Smoking and diabetes are the strongest risk factors for the development of peripheral artery disease, but also high cholesterol, high blood pressure and sedentary lifestyle. 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, while being highly effective in the conservative management of peripheral artery disease, 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.

Research Question: ‘In comparison with the routine care of peripheral artery disease, does TeGeCoach improve walking impairment while simultaneously lower the costs of health care?’

Methods: A prospective, open-label, multicenter randomized controlled clinical trial was designed 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, more clinical trials are needed to build evidence about home-based exercise programs to determine their clinical and cost effectiveness. The current routine care of PAD is partly ineffective und insufficient, with the consequence of a poorly served patient population, worsening disease condition and high mortality rates. 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.

Ethics and dissemination: Ethical approval was given by the ethics committee of the Medical Association Hamburg. The findings from this clinical trial will be disseminated through peer-reviewed publications and at scientific conferences.

Funding: This clinical trial receives funding from the German Innovation Fund (01NVF17013) by the Federal Joint Federal 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 (DLR). Neither the G-BA nor the DLR will be involved in the actual conduct of this work.