TREK-PAD: Telehealth Delivered Home-based Walking for Vets With Peripheral Artery Disease
Study Details
Study Description
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 we 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Objectives: The purpose of this proposed study is to evaluate two delivery methods of home-based walking among Veterans with PAD, using an innovative sequential multiple assignments, randomized trial (SMART) design to compare a web-based delivered walking program, and a video telehealth delivered walking program versus usual care among Veterans with PAD.
Design & Outcomes: Using a randomized control trial design with sequential multiple assignments, participants will be randomized to 1 of 3 arms; a web-based delivered (WBD) walking program, (ii) a video telehealth delivered (VTD) walking program, or (iii) usual care (UC) only.
Intervention & Duration: The interventions include i) the web-based delivered (WBD) walking program and (ii) the video telehealth delivered (VTD) walking program. All participants, irrespective of study assignment, will receive two in-person visits with an exercise physiologist prior to randomization. After 12 weeks, participants in the WBD arm who do not respond will be further randomized to receive WBD + VTD or WBD only, and participants in the VTD arm who do not respond will be further randomized to receive VTD + WBD or VTD only. Nonresponse will be defined as a <15% increase in maximal walk distance compared to baseline (measured with a validated treadmill protocol at 12 weeks). The interventions will then continue for an additional 12 weeks (for a total of 24 weeks of the intervention). After the 24-week visit, participants will be followed for an additional 12 weeks to examine longer-term responses for a total participant study duration of 36 weeks.
Outcomes include maximal and pain-free walking distance, and health-related quality of life (HRQOL) will be measured at all visits (i.e., baseline, 12-, 24-, and 36 weeks). The primary outcome of interest is a change in maximal walking distance from baseline to 12 weeks. Secondary outcomes include the change in maximal walking distance at 24 and 36 weeks and a change in pain-free walking distance and HRQOL at 12-, 24- and 36 weeks. Primary and secondary outcomes will be measured in all participants.
Sample Size & Population: A total of 225 Veterans with peripheral artery disease will be enrolled.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Internet-based Walking Program Weekly automated goals are delivered via email to the participant; goals are based on previous week's step count accumulation |
Behavioral: Walking Program
Walking program: is delivered either via an internet-based web site or via telehealth counseling 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.
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| Experimental: Telehealth Counseling Walking Program Weekly telehealth calls to assess compliance to exercise prescription and discuss various topics related to adoption and adherence to the walking program |
Behavioral: Walking Program
Walking program: is delivered either via an internet-based web site or via telehealth counseling 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.
|
Outcome Measures
Primary Outcome Measures
- Change in maximal walking distance [baseline to 12 weeks]
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
Secondary Outcome Measures
- Change in maximal walking distance [baseline to 24 weeks]
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
- Change in maximal walking distance [baseline to 36 weeks]
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
- Change in claudication free walking distance [baseline to 12 weeks]
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
- Change in claudication free walking distance [baseline to 24 weeks]
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
- Change in claudication free walking distance [baseline to 36 weeks]
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
- Change in PAD-specific health-related quality of life [baseline to 12 weeks]
measured using a disease specific validated questionnaire - the Peripheral Artery Questionnaire (PAQ) which uses scale scores of 0 to 100, with high numbers indicating better outcomes.
- Change in PAD-specific health-related quality of life [baseline to 24 weeks]
measured using a disease specific validated questionnaire - the Peripheral Artery Questionnaire (PAQ) which uses scale scores of 0 to 100, with high numbers indicating better outcomes.
- Change in PAD-specific health-related quality of life [baseline to 36 weeks]
measured using a disease specific validated questionnaire - the Peripheral Artery Questionnaire (PAQ) which uses scale scores of 0 to 100, with high numbers indicating better outcomes.
- Change in general health-quality of life [baseline to 12 weeks]
Measuring using the Patient-Reported Outcomes Measurement Information System (PROMIS). The PROMIS 29 include 4 questions form each of 7 domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability's to participate in social roles and activities. The PROMIS-29 yields scores for each of the domains above and a total score.
- Change in general health-quality of life [baseline to 24 weeks]
Measuring using the Patient-Reported Outcomes Measurement Information System (PROMIS). The PROMIS 29 include 4 questions form each of 7 domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability's to participate in social roles and activities. The PROMIS-29 yields scores for each of the domains above and a total score.
- Change in general health-quality of life [baseline to 36 weeks]
Measuring using the Patient-Reported Outcomes Measurement Information System (PROMIS). The PROMIS 29 include 4 questions form each of 7 domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability's to participate in social roles and activities. The PROMIS-29 yields scores for each of the domains above and a total score.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Men and women
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Diagnosis of lower extremity PAD due to atherosclerosis
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Claudication with walking defined as stage 1-3 on the Rutherford Scale
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Medical clearance from the patient's primary care provider or vascular care provider
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Ability to walk at least one city block
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Self-reported sedentary behaviors defined as < 150 minutes per week of physical activity
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Access to a phone and/or email & Internet
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Competent to provide informed consent
Exclusion Criteria:
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Life expectancy of less than six months
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Comorbidities that limit walking to a severe degree (i.e., wheelchair-bound)
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Resident of a nursing home
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Recent enrollment in an exercise program or performing 150 minutes per week or more of exercise
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Planned revascularization or amputation in the next two months
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Recent CVD events (< 3 months) including stroke/TIA, MI, UA, PCI/CABG
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Unstable cardiac conditions (severe valve disease, NYHA class III-IV heart failure, untreated complex congenital heart disease, or complex arrhythmias)
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Current substance abuse
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Psychiatric disorder which limits the patient's ability to follow the study protocol, Pregnancy
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Inability to speak and read English
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Birmingham VA Medical Center, Birmingham, AL | Birmingham | Alabama | United States | 35233-1927 |
| 2 | VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California | United States | 94304-1207 |
| 3 | Rocky Mountain Regional VA Medical Center, Aurora, CO | Aurora | Colorado | United States | 80045 |
Sponsors and Collaborators
- VA Office of Research and Development
Investigators
- Principal Investigator: Elizabeth A Jackson, MD, Birmingham VA Medical Center, Birmingham, AL
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- E3965-R