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