Role of Provider Feedback in Home-based Walking Programs Utilizing Smart Devices

The study design is that of a prospective randomized study of patients presenting to the vascular surgery and cardiology clinics with symptoms of IC and enrolled in 12-week supervised exercise program. Upon enrollment, each patient will undergo a medical and surgical history, ascertainment of smoking status, review of medications, and 6-minute walk test (walking on a flat, pre-defined course(i.e. hallway) for 6 minutes and recording time and distance to claudication onset as well as total distance walked, and total number of steps taken). We will also collect data from the patient's CPRS notes through our institutional cardiac rehab/PAD rehab program, with a dedicated cardiac rehab nurse. Patients with IC who are enrolled in the study will also be asked to complete 2 QOL questionnaires: the VASCUQoL6 and the Walking Impairment Questionnaire (WIQ). Patients will undergo supervised exercise therapy (per cardiac rehab protocol) and will receive the LIVMOR health monitoring system with instructions on how to use it. Randomization and details of exercise therapy are described in the next section. Patients will be followed for up to 12 weeks to collect data regarding change in distance and time of claudication onset.

In the optional exploratory aim, we will analyze plasma from one blood draw at the beginning and at the end of exercise therapy for lipid levels, distribution of LDL particle size, and other biomarkers. We will perform metabolomics, proteomics, and lipidomics assays to examine small circulating molecules that are involved in the development of atherosclerotic plaque in peripheral arterial disease. All blood and plasma analysis performed outside of Pathology and the Clinical Core Lab will be performed in the PI's research laboratory at the Dallas VA Medical Center by members of the research staff, or by members of the PI's collaborating lab at UT Southwestern or in the UT Southwestern research Core Laboratories. Any plasma sent to UT Southwestern will be de-identified.

Data (including name, birth date, social security number, dates of procedures and studies) will be stored in an Excel spreadsheet. Each patient's data will be associated with a study ID and stripped of the 18 identifiers need to de-identify the data. Only study staff will have access to PHI. No PHI will be released outside the North Texas VA Health Care Systems.

For the LIVMOR system, only the patient's study ID will be entered into the system. De-identified health monitoring data (heart rate, steps taken, distance walked) will be transmitted and stored in the LIVMOR cloud server, as was done in the LIVMOR Data Collection Study (IRB# 17-106).

After enrollment, baseline data, including questionnaires, will be collected. Patients who have agreed to optional blood draw will have a fasting blood draw (up to 10 cc) at the next available time within 1 week of study enrollment. At the next supervised exercise therapy visit (occurs 3 times a week according to the cardiac rehab protocol), the patient will have baseline resting heart rate and blood pressure measurements, and will undergo a 6-minute walk test. The patient will be randomized to remote coaching (regular provider feedback based on LIVMOR data) vs. remote health monitoring without provider feedback. Each patient will be sent home with instructions for home-based supplemental exercise and a LIVMOR remote health monitoring system, which includes a wristwatch that records heart rate, steps taken, and distance traveled (pedometer function) and a tablet. Patients will be instructed to check a resting heart rate with the LIVMOR watch for 10 minutes before starting exercise. They will exercise while wearing the watch (heart rate monitor and pedometer), then check heart rate for 10 minutes after completion of the exercise session. Patients will not receive real time feedback from the smart-watch heart rate monitor, however they have the option to review their heart rate and pedometer data by logging into the tablet provided with the watch, after the exercise session. In patients randomized to the remote coaching arm, study staff will provide feedback on home-based supplemental exercise based on heart rate measurements and pedometer measurements from the LIVMOR health monitoring system, as well as heart rate and walking data collected from supervised exercise therapy sessions. Remote coaching will occur by telephone call, but the conversation will mirror conversations that occur during supervised exercise therapy, and will not be based solely on the surrogate measure of heart rate for walking effort. A member of the study team will call the patient 1-3 times a week, depending on the patient's preference, which may change over the course of the study. Therefore the remote coaching is adaptive to patient's needs. In patients randomized to no remote coaching, health monitoring data will be reviewed by study staff, but will not be used to adjust home-based supplemental exercise. Any abnormalities in health monitoring data will be alerted to appropriate clinical staff. All patients will keep a journal of their home-based supplemental exercise, including time of exercise, in order to correlate heart rate readings from the smart-watch.