RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Telehealth Delivered Home-based Walking for Vets With Peripheral Artery Disease (TREK-PAD)

Quick Facts

Study Start:2024-07-01
Study Completion:2027-10-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06033924

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men and women
  2. * Diagnosis of lower extremity PAD due to atherosclerosis
  3. * Claudication with walking defined as stage 1-3 on the Rutherford Scale
  4. * Medical clearance from the patient's primary care provider or vascular care provider
  5. * Ability to walk at least one city block
  6. * Self-reported sedentary behaviors defined as \< 150 minutes per week of physical activity
  7. * Access to a phone and/or email \& Internet
  8. * Competent to provide informed consent
  1. * Life expectancy of less than six months
  2. * Comorbidities that limit walking to a severe degree (i.e., wheelchair-bound)
  3. * Resident of a nursing home
  4. * Recent enrollment in an exercise program or performing 150 minutes per week or more of exercise
  5. * Planned revascularization or amputation in the next two months
  6. * Recent CVD events (\< 3 months) including stroke/TIA, MI, UA, PCI/CABG
  7. * Unstable cardiac conditions (severe valve disease, NYHA class III-IV heart failure, untreated complex congenital heart disease, or complex arrhythmias)
  8. * Current substance abuse
  9. * Psychiatric disorder which limits the patient's ability to follow the study protocol
  10. * Pregnancy
  11. * Inability to speak and read English

Contacts and Locations

Study Contact

Elizabeth A Jackson, MD
CONTACT
(205) 933-8101
elizabeth.jackson2@va.gov

Principal Investigator

Elizabeth A Jackson, MD
PRINCIPAL_INVESTIGATOR
Birmingham VA Medical Center, Birmingham, AL

Study Locations (Sites)

Birmingham VA Medical Center, Birmingham, AL
Birmingham, Alabama, 35233-1927
United States
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1207
United States
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045-7211
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-01
Study Completion Date2027-10-29

Study Record Updates

Study Start Date2024-07-01
Study Completion Date2027-10-29

Terms related to this study

Keywords Provided by Researchers

  • peripheral artery disease
  • physical activity
  • quality of life

Additional Relevant MeSH Terms

  • Peripheral Artery Disease