Telehealth Delivered Home-based Walking for Vets With Peripheral Artery Disease

Summary

Walking is beneficial for adults with peripheral arterial disease. Benefits include the ability to walk for longer periods and general well being (quality of life). This study will look at two types of delivery methods for a home-based walking program. The walking program includes step count goals, information on healthy walking and motivational messages. The two delivery methods include a web-based delivery and an telehealth delivery. Participants are randomized to either one of the delivery methods or usual care. After 12 weeks participants in the web based or telehealth based groups maybe re-randomized to receive a combination of both web-based and telehealth for a second 12 week period. After 24 weeks, everyone is followed for an additional 12 weeks, so the total time a participant is in the study is 36 weeks. At baseline, 12, 24 and 36 weeks the investigators ask participant to walk (slowly) on a treadmill, perform a six-minute walk test, and several questionnaires on quality of life. Vouchers are provided at each study visit. All participants who complete the study also keep their pedometer.

Conditions

• Peripheral Artery Disease

Interventions

BEHAVIORAL

Walking Program: Internet-based

Internet pages allow participants to see step-count goals, progress over time and access to walking tips for 12 weeks. Among participants who do not increase their step counts (\>15%), these non-responders will be rerandomized to received the combination of internet and telehealth or either along for an additional 12-weeks (total intervention time is 24-weeks). A follow-up phase of 12-weeks will be completed for a total participant duration of 36 weeks.

BEHAVIORAL

Walking Program: Telehealth-based

Telehealth sessions allow participants review step-count goals, progress over time and access to walking tips with the study coordinator for 12 weeks. Among participants who do not increase their step counts (\>15%), these non-responders will be rerandomized to received the combination of internet and telehealth or either along for an additional 12-weeks (total intervention time is 24-weeks). A follow-up phase of 12-weeks will be completed for a total participant duration of 36 weeks.

Sponsors & Collaborators

• VA Office of Research and Development

  lead FED

Principal Investigators

• Elizabeth A Jackson, MD · Birmingham VA Medical Center, Birmingham, AL

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-07-01

Primary Completion

2027-10-29

Completion

2027-10-29

Countries

• United States

Study Locations