This pilot study will use mobile-health technology to deliver an intervention designed for lasting physical activity behavior change. The study will assess the feasibility of using the Physical Activity Behavior Change(PABC) intervention for Veterans with lower limb amputation. This intervention will be delivered using wrist-worn wearable activity sensors and a home-based tablet computer to allow real-time physical activity feedback and video interface between the participants and the therapist.
This pilot study will assess the feasibility of using the Physical Activity Behavior Change(PABC) intervention for Veterans with dysvascular lower limb amputation. In addition, preliminary efficacy of the PABC intervention will be assessed using a two-group randomized cross-over design. Testing will occur at baseline (pre-intervention), three months (end of intervention), and six months. The primary aim is to determine feasibility of using the PABC intervention with Veterans who have dysvascular amputation by measuring: 1. participant retention 2. dose goal attainment 3. participant acceptability 4. safety The secondary aim is to preliminary assess efficacy of the PABC intervention by measuring accelerometer-based physical activity and self-report disability effect sizes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
31
Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, United States
Retention Rate
Retention rate will be measured as the percent of participants enrolled in the intervention who complete the intervention.
Time frame: 3 months
Dose Goal Attainment
Dose goal attainment will be measured as the percent of participants in the intervention phase of the study who meet the dose goal of an average 3% increase in daily steps.
Time frame: 3 months
Acceptability
Acceptability will be measured using the mean score of the Intrinsic Motivation Inventory - Interest / Enjoyment Subscale. The scores range from 1 to 7, with higher numbers indicating higher acceptability, and a null value of 5.0.
Time frame: 3 months
Study-Related Adverse Events
Safety will be assessed as differences in rates of study-related adverse events between GROUP 1 and GROUP 2 during the first three months, when GROUP 1 is in the intervention phase and GROUP 2 is in the non-intervention control phase.
Time frame: 3 months
Accelerometer-Based Physical Activity
Physical activity counts will be measured using a waist-mounted accelerometer-based physical activity monitor (Actigraph). The outcome will be average daily physical activity counts.
Time frame: 3 months
Late Life Function and Disability Scale, Frequency
The Late Life Function and Disability Scale (LLFDSI) will be used to assess the participant-reported disability at each test point. Scores range from 0 to 100, with higher scores indicating higher disability.
Time frame: 3 months
Accelerometer-Based Physical Activity
Physical activity counts will be measured using a waist-mounted accelerometer-based physical activity monitor (Actigraph). The outcome will be average daily physical activity counts.
Time frame: 6 months
Late Life Function and Disability Scale, Frequency
The Late Life Function and Disability Scale (LLFDSI) will be used to assess the participant-reported disability at each test point. Scores range from 0 to 100, with higher scores indicating higher disability.
Time frame: 6 months
Late Life Function and Disability Scale, Limitation
The Late Life Function and Disability Scale (LLFDSI) will be used to assess the participant-reported disability at each test point. Scores range from 0 to 100, with higher scores indicating higher disability.
Time frame: 3 months
Late Life Function and Disability Scale, Limitation
The Late Life Function and Disability Scale (LLFDSI) will be used to assess the participant-reported disability at each test point. Scores range from 0 to 100, with higher scores indicating higher disability.
Time frame: 6 months
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