Telehealth Delivered Home-based Walking for Vets With Peripheral Artery Disease
TREK-PAD
1 other identifier
interventional
225
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2024
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2023
CompletedFirst Posted
Study publicly available on registry
September 13, 2023
CompletedStudy Start
First participant enrolled
July 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 29, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 29, 2027
May 6, 2026
April 1, 2026
3.3 years
September 5, 2023
April 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in maximal walking distance
measured using the Gardener-Sinner protocol treadmill test, a validated protocol for measuring maximal and claudication free walking distance among patients with PAD, used in clinical care
baseline to 12 weeks
Secondary Outcomes (11)
Change in maximal walking distance
baseline to 24 weeks
Change in maximal walking distance
baseline to 36 weeks
Change in claudication free walking distance
baseline to 12 weeks
Change in claudication free walking distance
baseline to 24 weeks
Change in claudication free walking distance
baseline to 36 weeks
- +6 more secondary outcomes
Study Arms (2)
Internet-based Walking Program
EXPERIMENTALInternet pages allow participants to see step-count goals, progress over time and access to walking tips
Telehealth Counseling Walking Program
EXPERIMENTALTelehealth sessions allow participants review step-count goals, progress over time and access to walking tips with the study coordinator
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
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
Related Publications (1)
Jackson EA, Aldama G, Spangler E, Richman J, Henderson K, Dutton G, Dempsey D, Guzman A, Myers J. The telehealth vs. web-based delivered home-based walking for veterans with peripheral artery disease (TREK-PAD) trial. Contemp Clin Trials. 2026 Jan;160:108139. doi: 10.1016/j.cct.2025.108139. Epub 2025 Nov 7.
PMID: 41205861BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth A Jackson, MD
Birmingham VA Medical Center, Birmingham, AL
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2023
First Posted
September 13, 2023
Study Start
July 1, 2024
Primary Completion (Estimated)
October 29, 2027
Study Completion (Estimated)
October 29, 2027
Last Updated
May 6, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share