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

Conditions

• Peripheral Artery Disease

Eligibility Criteria

Sex

ALL

Age

21 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

Jul 1, 2024

Status verified

Apr 2026

Primary completion

Oct 29, 2027

Completion

Oct 29, 2027

Study Design

Enrollment

225 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: Internet-based Walking Program
  Internet pages allow participants to see step-count goals, progress over time and access to walking tips
• Experimental: Telehealth Counseling Walking Program
  Telehealth sessions allow participants review step-count goals, progress over time and access to walking tips with the study coordinator

Primary Outcome Measure

Change in maximal walking distance [ Time Frame: baseline to 12 weeks ]

Central Contacts

• Elizabeth A Jackson, MD
  (205) 933-8101
  [email protected]
• Megan A Baker, BS
  (205) 240-6552
  [email protected]

Locations (3)

Find similar trials in Birmingham, AL

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