gms | German Medical Science

Background: Peripheral artery disease is the third most prevalent cardiovascular disease worldwide, with smoking and diabetes being the strongest risk factors. Most prominent symptom is intermittent claudication, leg pain that is caused by too little blood flow during exertion. To improve mobility, first line treatment for intermittent claudication are supervised exercise programs, yet its use is limited by costs, reimbursements, availability, and patient adherence, and, therefore, difficult to implement in routine care. Given the currently existing health care deficits in the management of intermittent claudication, this study is investigating the clinical and cost effectiveness of TeGeCoach, an innovative home-based exercise program with telemonitoring to improve walking impairment in patients with peripheral artery disease. Our aim is to describe the recruitment process and intervention implementation, and provide baseline characteristics of enrolled patients.

Methods: TeGeCoach is a pragmatic, open-label, parallel-group, multicenter randomized controlled clinical trial embedded within three German statutory health insurances (KKH Kaufmännische Krankenkasse, TK Techniker Krankenkasse, mhplus Krankenkasse). The goal was to recruit 1760 participants with peripheral artery disease at Fontaine stage II, identified from claims data using ICD diagnosis codes, randomized to TeGeCoach on top of care as usual (CAU) or CAU alone. The 12-month TeGeCoach intervention consists of interval training together with motivational interviewing-based health coaching and intensified medical supervision. Participants wear an activity tracker device to track their personal exercise progress and to retrieve feedback about their performance from their health coach. TeGeCoach participants must also attend medical check-ups to ensure patient safety and are referred to a physician by their health coach prior to program start. Primary endpoints are functional capacity (Walking Impairment Questionnaire) and total health care costs (claims data) measured at baseline, 12 and 24 months.

Results: Recruitment lasted from April to December 2018. A total of 63.209 individuals who fulfilled the inclusion criteria were identified and contacted to be recruited, leading to 1981 study enrolments (patient participation rate: 3.1%). Of these, 993 participants were randomized to the TeGeCoach intervention group. Regarding the implementation of TeGeCoach, 627 out of 1165 contacted physicians agreed to participate in the study (physician participation rate: 53.8%). Consequently, 348 receive no intervention (35.0%) as no appropriate physician could be referred close to the participants' home. The majority of included physicians are general practitioners (n=351, 56.0%) and internists (n=187, 29.8%). The response rate of patient questionnaires is 87% (n=1765). Baseline data, including demographics, clinical history, current functional status, will be analyzed in mid-2019, and reported and discussed at the congress.

Discussion: The TeGeCoach study exceeded its questionnaire response rate goal and will shed further light on the (long-term) effectiveness of home-based exercise programs for the management of intermittent claudication as well as its implementation potential in health care settings. The information provided should assist other investigators who are planning and conduct similar pragmatic trials, particularly trials involving physicians. Since the implementation of TeGeCoach depends on the participation of physicians, the unwillingness of many physicians to participate poses a challenge for the intervention implementation and highlights the need for greater engagement in clinical trials.