Claudication, Intermittent, Peripheral Artery Disease
Conditions
Brief summary
This is a randomized controlled trial evaluating the impact of the mobile phone delivered SVS SET Program on utilization, functional capacity, symptoms and quality of life.
Detailed description
This is a national randomized controlled study with approximately 10-15 sites enrolling patients with Rutherford II peripheral artery disease (PAD) in total. Patients will be randomized between the SVS SET Program and usual care for each site. The primary outcome will be to study the site-specific effect on utilization of exercise therapy. Secondary outcomes will be the effect on the 6-minute-walk test, passive activity and quality of life.
Interventions
BEHAVIORALExercise Therapy
This is a health coach driven exercise prescription for patients recommending 30 minutes or more of moderate effort walking 3-5 days a week with expected walk-rest-walk-rest intervals.
Sponsors
Society for Vascular Surgery
Palo Alto Veterans Institute for Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Block randomization stratified by site.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of Age * Rutherford Class I-II PAD (claudication) * Ambulatory * Exercise Therapy Naive (\>18 mo) * Primary Owner of an Android or iOS device * Willingness to participate (text, call, fill out surveys) via a mobile phone
Exclusion criteria
* Symptomatic coronary artery disease * Oxygen dependent COPD * Significant osteoarthritis limiting ambulation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Complete a 12-week Exercise Therapy Program | 12 weeks. | Completion of a 12-week program in the treatment group will be completion of the remote SVS SET Program while the usual care group may have an in-person 12-week exercise therapy program. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mobile Phone Delivered 6-Minute Walk Test | Weeks 0, 6 and 12 | Mobile-phone delivered 6-minute walk test result in steps to be reported at three time points. |
| Passive Activity as Measured on Mobile Device | 12 weeks. | Daily passive step count activity as measured by sensors in mobile phone. |
| Quality of Life Survey as measured by the mini-Walking Impairment Questionnaire (mini-WIQ) | Weeks 1, 6, and 12 | QoL questionnaires will be asked on the mobile phone at three time points. |
| Adherence as Measured by Completion of Scheduled Daily Walks | 12 weeks. | Adherence to the recommended exercise therapy frequency (3 walks per week) and duration (for at least 30 minutes or more) will be measured |
| Freedom From Intervention as Measured by Absence of Surgical Intervention at One Year | 1 year. | Freedom from any surgical intervention will be reported at one year by performing a chart review. |
Outcome results
None listed