Telehealth delivered home-based walking for vets with Peripheral Artery Disease (TREK-PAD)

ABSTRACT Over 8 million Americans carry a diagnosis of peripheral artery disease (PAD), which is associated with a significant risk for functional disability, cardiovascular events, and death. Furthermore, the risk of PAD and adverse outcomes related to PAD, including amputations, are greater among minority groups. It is well known that physical activity, such as walking, can reduce the risk of cardiovascular disease (CVD) and all-cause mortality among vascular patients. For patients with PAD who experience claudication (pain with walking), PAD management should include regular exercise such as walking. Despite guideline recommendations for center- based exercise programs, few facilities offer such programs. Among those that offer center-based programs, patients experience significant barriers to attendance. Developing effective and accessible interventions to promote physical activity among patients, including Veterans who have high PAD rates, is warranted. The purpose of this proposed study is to evaluate two delivery methods of home-based walking among Veterans with PAD, using an innovative sequential multiple assignments, randomized trial (SMART) design to compare a web-based delivered walking program, and a video telehealth delivered walking program versus usual care among 225 Veterans with PAD in three sites (Birmingham AL, Palo Alto CA, and Denver CO). Participants will be randomized to 1 of 3 arms; (i) the web-based delivered (WBD) program, (ii) the video telehealth delivered (VTD) program, or (iii) usual care (UC). All participants, irrespective of study assignment, will receive 2 in-person visits with an exercise physiologist prior to randomization. After 12-weeks, participants in the WBD arm who do not respond will be further randomized to receive WBD + VTD or WBD only. At 24- weeks, participants in the VTD arm who do not respond will be further randomized to receive VTD + WBD or VTD only. Nonresponse will be defined as a <15% increase in maximal walk distance compared to baseline (measured with a validated treadmill protocol at 12-weeks). The interventions will then continue for an additional 12-weeks. After the 24-week visit, participants will be followed for an additional 12 weeks to examine longer- term responses for a total participant study duration of 36-weeks. Visits at baseline, 12-, 24- and 36-weeks include maximal and pain-free walking distance and health-related quality of life (HRQOL). The primary outcome of interest will be change in maximal walking distance from baseline to 12-weeks. Secondary outcomes include change in maximal walking distance at 24-, and 36-weeks, and change in pain-free walking distance, and HRQOL at 12-, 24- and 36-weeks. Primary and secondary outcomes will be measured in all participants. Impact: This trial will be the first to use a SMART design to compare two delivery methods for a home-based walking program tailored to Veterans with PAD. With this study, we address a major gap in current knowledge relating to the effective delivery of home-based walking programs. In addition, the proposal is well aligned with the VA’s special emphasis area, mission, and strategic goals, which include the evaluation of nonpharmacologic interventions to promote physical activity and reduce pain.