The purpose of this study is to evaluate the feasibility of a digital health platform coupled with walking activity tracking for patients with Peripheral Artery Disease (PAD) and symptoms limited to claudication.
This is a two center, non-blinded, 2 period randomized crossover trial. 50 patient subjects are planned. Patient participants will be identified and recruited from clinical environments (including clinics and diagnostic testing departments) at participating sites. Diagnosis and testing will occur through usual clinical care, and participants will not incur financial costs related to participation. A crossover design will be utilized, where all participants will use the VOICE platform with activity tracking for 35 days and usual care for 30 days. Randomization will determine the order in which participation in the VOICE phase versus the usual care phase occur. Randomization will occur using a closed envelope system. For patients in the VOICE platform group, data collection will occur over a total of 35 days, including an initial 5-day "run in" period during which participants will orient themselves to the system. Each provider participant will receive a single end-user survey evaluating VOICE from their perspective. Screening of patients electronic medical records will be done to determine subject eligibility. Subjects who meet all inclusion criteria will be approached to participate. Total duration of subject participation will be 9 weeks during the control and intervention phases, with a final follow-up survey at 6 months post-enrollment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
28
During the VOICE (intervention) phase, participants will use the digital health platform plus Fitbit walking activity tracking for a total of five weeks (one week run-in phase plus four week study phase)
During usual care, patients will self-report on a daily basis if they met the walking exercise goal consistent with instructions from their clinician. Self-report will be recorded as a daily categorical (yes/no) variable.
University of Michigan - Vascular Surgery Section
Ann Arbor, Michigan, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
Walking adherence (days with walking exercise/total days per study period)
Self-reported walking adherence based on a daily log will be compared with exercise assessed using tracked walking activity during the VOICE/Fitbit phase. Adherence will be evaluated based on number of days during the study period where walking exercise was performed, and will be evaluated as a categorical (yes/no) variable.
Time frame: 2 months
Tracked Walking Activity: Distance (meters)
Distance in kilometers/miles recorded by Fitbit during VOICE intervention phase.
Time frame: 2 months
Tracked Walking Activity: Steps (count)
Number of steps recorded by Fitbit device during VOICE intervention phase.
Time frame: 2 months
Tracked Walking Activity: Time (minutes)
Number of minutes/hours recorded by Fitbit during VOICE intervention phase.
Time frame: 2 months
Tracked Walking Activity: Cadence (steps per minute)
Average steps per minute recorded by Fitbit during VOICE intervention phase.
Time frame: 2 months
Sleep interruption (mean nightly frequency)
While in VOICE/Fitbit phase, user data is collected by the unit for each sleep cycle including sleep duration, schedule, and quality. The data collected also shows insight into the number of sleep disruptions, restless periods, and minutes awake. This will only be tracked and recorded using Fitbit for the duration of the VOICE/Fitbit intervention phase.
Time frame: 2 months
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PROMIS Pain Interference Short Form 6a (raw score, T-score conversion)
Patient-Reported Outcomes Measurement Information System designed to gauge the level to which pain interferes with the participant's social, work, and day-to-day household activities. This six-item assessment yields total values ranging from 4 (low) to 20 (high) based on reported severity of pain interference, within a seven day duration. This measure will be repeated three times across the study and the data will be analyzed to determine consistency, improvement, and/or deterioration of quality.
Time frame: 1 month, 2 months, 6 months
PROMIS Physical Function Short Form 6b (raw score, T-score conversion)
Patient-Reported Outcomes Measurement Information System short form questionnaire designed to gauge the level to which the participant feels their disease limits their ability to perform daily tasks and activities, at the time of the assessment. This six-item questionnaire yields total values ranging from 6 to 30, with a higher score representing a higher level of functional ability. This measure will be repeated three times across the study and the data will be analyzed to determine consistency, improvement, and/or deterioration of quality.
Time frame: 1 month, 2 months, 6 months
PROMIS Sleep Disturbance Short Form 4a (raw score, T-score conversion)
Patient-Reported Outcomes Measurement Information System is a short form questionnaire administered to participants to gauge sleep depth and quality, within a seven day duration. This nine-item assessment is a combination of items in which participants are asked to respond either affirmatively or negatively, and with a subset of questions scored on a numerical scale with a raw score ranging from 4 (low) to 20 (high). This measure will be repeated three times across the study and the data will be analyzed to determine consistency, improvement, and/or deterioration of quality.
Time frame: 1 month, 2 months, 6 months
VascuQol-6
The Vascular Quality of Life Questionnaire, or VascuQoL-6, is a disease-specific instrument in which the participant is asked about their concerns, abilities, and activities, referencing the previous two-week time frame. Overall values can range from 6 to 24 for the VascuQoL-6, with a higher total sum representing better participant health. This measure will be repeated three times across the study and the data will be analyzed to determine consistency, improvement, and/or deterioration of quality.
Time frame: 1 month, 2 months, 6 months