NCT06033924 Telehealth Delivered Home-based Walking for Vets With Peripheral Artery Disease
| NCT ID | NCT06033924 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Peripheral Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 225 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2027-10-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 225 participants in total. It began in 2024-07-01 with a primary completion date of 2027-10-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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 * Ability to walk at least one city block * Self-reported sedentary behaviors defined as \< 150 minutes per week of physical activity * Access to a phone and/or email \& Internet * Competent to provide informed consent Exclusion Criteria: * 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 * Planned revascularization or amputation in the next two months * Recent CVD events (\< 3 months) including stroke/TIA, MI, UA, PCI/CABG * Unstable cardiac conditions (severe valve disease, NYHA class III-IV heart failure, untreated complex congenital heart disease, or complex arrhythmias) * Current substance abuse * Psychiatric disorder which limits the patient's ability to follow the study protocol * Pregnancy * Inability to speak and read English
Contact & Investigator
Elizabeth A Jackson, MD
PRINCIPAL INVESTIGATOR
Birmingham VA Medical Center, Birmingham, AL
Frequently Asked Questions
Who can join the NCT06033924 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Peripheral Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06033924 currently recruiting?
Yes, NCT06033924 is actively recruiting participants. Contact the research team at elizabeth.jackson2@va.gov for enrollment information.
Where is the NCT06033924 trial being conducted?
This trial is being conducted at Birmingham, United States, Palo Alto, United States, Aurora, United States.
Who is sponsoring the NCT06033924 clinical trial?
NCT06033924 is sponsored by VA Office of Research and Development. The principal investigator is Elizabeth A Jackson, MD at Birmingham VA Medical Center, Birmingham, AL. The trial plans to enroll 225 participants.