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

ConditionPeripheral Artery Disease

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age21+

SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men and women

Diagnosis of lower extremity PAD due to atherosclerosis

Claudication with walking defined as stage 1-3 on the Rutherford Scale

Medical clearance from the patient's primary care provider or vascular care provider

Disqualifiers

Life expectancy of less than six months

Comorbidities that limit walking to a severe degree (i.e., wheelchair-bound)

Resident of a nursing home

Recent enrollment in an exercise program or performing 150 minutes per week or more of exercise

Trial design

Design model

Parallel

Treatments tested in this trial

Walking Program: Internet-based
Behavioral
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.
Walking Program: Telehealth-based
Behavioral
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.

Treatment groups

225 Participants

are divided into 2 treatment groups

Group A: Internet-based Walking ProgramExperimental treatment 1 intervention

Group B: Telehealth Counseling Walking ProgramExperimental treatment 1 intervention