Telehealth Delivered Home-based Walking for Vets With Peripheral Artery Disease (TREK-PAD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 225
- 试验地点
- 6
- 主要终点
- Change in maximal walking distance
研究概览
简要总结
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.
详细描述
The objective of this study is to evaluate two delivery methods of home-based walking among Veterans with PAD. The investigators will use an innovative sequential multiple assignment, randomized trial (SMART) design to compare a web-based delivered (WBD) walking program and a video telehealth delivered (VTD) walking program versus usual care among 225 Veterans with peripheral arterial disease (PAD) in three sites (Birmingham AL, Palo Alto CA, and Aurora CO).
This trial has two study aims and one exploratory aim. Aim 1 is to evaluate the efficacy of two remote delivery methods to increase maximal walking distance, pain-free walking distance, and health-related quality of life (HRQOL) compared to baseline, among Veterans with PAD. The investigators hypothesize that at 12-weeks, participants initially randomized to the WBD program and the VTD program will have greater improvement in maximal walking distance (primary outcome) compared to usual care (UC). Furthermore, this improvement (for both WBD and VTD) will be sustained at 24-weeks compared to UC, and at 12- and 24-weeks, both the WBD program and the VTD program will produce greater improvement in pain-free walking distance and HRQOL compared to UC.
Study aim 2 is to evaluate the efficacy of the combination of WBD with a VTD walking program among Veterans who do not respond to their initial assignment. The investigators hypothesize that at 24- and 36-weeks, the combination of WBD+VTD will produce greater improvements in maximal walking distance (from second randomization at 12-weeks) compared to either WBD or VTD alone.
The exploratory aim is to compare the efficacy of WBD and VTD and to examine factors associated (age, race/ethnicity, rural residency, engagement, co-morbidities (including CVD risk), and PAD symptoms/severity) with initial response to WBD and VTD to identify the most effective strategy to increase mobility in 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Internet-based Walking Program
Internet pages allow participants to see step-count goals, progress over time and access to walking tips
干预措施: Walking Program: Internet-based (Behavioral)
Telehealth Counseling Walking Program
Telehealth sessions allow participants review step-count goals, progress over time and access to walking tips with the study coordinator
干预措施: Walking Program: Telehealth-based (Behavioral)
结局指标
主要结局
Change in maximal walking distance
时间窗: 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
次要结局
- Change in PAD-specific health-related quality of life(baseline to 36 weeks)
- Change in maximal walking distance(baseline to 36 weeks)
- Change in claudication free walking distance(baseline to 36 weeks)
- Change in general health-quality of life(baseline to 36 weeks)
- Change in maximal walking distance(baseline to 24 weeks)
- Change in claudication free walking distance(baseline to 12 weeks)
- Change in claudication free walking distance(baseline to 24 weeks)
- Change in PAD-specific health-related quality of life(baseline to 12 weeks)
- Change in PAD-specific health-related quality of life(baseline to 24 weeks)
- Change in general health-quality of life(baseline to 12 weeks)
- Change in general health-quality of life(baseline to 24 weeks)