Project VOICE: Vascular Outcomes Improvement Through Collection of PatiEnt Reported Data

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.

Distance in kilometers/miles recorded by Fitbit during VOICE intervention phase.

Number of steps recorded by Fitbit device during VOICE intervention phase.

Number of minutes/hours recorded by Fitbit during VOICE intervention phase.

Average steps per minute recorded by Fitbit during VOICE intervention phase.

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.

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.

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.

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.

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.

Dominant hand grip strength will be measured and recorded by study staff, using a Jamar hand dynamometer. The participant will be directed to squeeze the unit's handle to obtain a "peak-hold" reading, with a potential isometric grip force ranging from 0-200lbs (90kgs). The numerical output will be recorded as part of the participant's chart to be analyzed and compared with the investigator's data set.

Ankle-brachial index (ABI) is a diagnostic measure used by providers to determine the likelihood and severity of blocked arteries, due to peripheral artery disease. ABI is calculated by comparing the ratio of the recorded blood pressure at a participant's ankle to the pressure in the upper arm. Participant's previous ABI values in MiChart will be used to determine eligibility at time of enrollment. Newly ordered ABI studies will then be tracked by study staff and recorded to be analyzed with the data set, for the duration of their participation in the study.

PAD-specific imaging or diagnostic tests (based on electronic medical record)

Any clinical treatment interventions performed during the study period will be captured, including: initiation of symptomatic pharmacotherapy, procedures related to PAD (including lower extremity CTA, MRA, angiography, revascularization procedures, or surgical procedures). This outcome will be assessed using the patient electronic medical record in addition to patient self-report.

Steps per day selected as walking goal at initiation of the VOICE/Fitbit phase

At completion of the VOICE/Fitbit phase, participants will be asked if they changed their daily walking goal from baseline. The updated (new) goals will be recorded for those who respond "yes".