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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Peripheral Artery Disease

Intervention / Treatment
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* Behavioral: VOICE/Fitbit
* Other: Daily self-reported exercise adherence


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of symptomatic PAD with claudication Ankle- brachial index (ABI) ≤ 0.9 or non-compressible leg arteries Walking exercise therapy recommended as treatment for PAD by the healthcare provider Willingness to be randomized to VOICE platform or control group Ability to access the internet Willing to sign an informed consent Exclusion Criteria: Walking exercise therapy not recommended due to contraindication or any other reason Wheelchair dependence or inability to walk unassisted Presence of foot ulcers, wounds, or gangrene History of major extremity amputation Lack of objective physiologic data validating PAD diagnosis Claudication symptoms due to diagnoses other than PAD (i.e., popliteal entrapment syndrome) Inability to speak or read English Severe mental illness Inability to give informed consent

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized, non-blinded crossover study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VOICE/Fitbit<br>VOICE enrollment with Fitbit walking activity tracking. During the VOICE phase, participants will use the digital health platform that integrates PAD-specific educational content, surveys, and Fitbit walking activity tracking for a total of five weeks (one week run-in phase plus four week study phase). | Behavioral: VOICE/Fitbit<br>* 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)<br>* Other names: Digital health platform plus tracked exercise;|
| Other: Daily self-reported exercise adherence<br>Usual care prescribed by physician (walking exercise instructions). During the Usual Care control phase, participants will conduct walking exercise based on instructions received in clinic. Walking exercise will be tracked and self-reported by participants, using a written calendar log. Participants will not have access to the VOICE platform, or use of Fitbit technology during this phase. | Other: Daily self-reported exercise adherence<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tracked Walking Activity: Distance (meters) | Distance in kilometers/miles recorded by Fitbit during VOICE intervention phase. | 2 months | 
| Tracked Walking Activity: Steps (count) | Number of steps recorded by Fitbit device during VOICE intervention phase. | 2 months | 
| Tracked Walking Activity: Time (minutes) | Number of minutes/hours recorded by Fitbit during VOICE intervention phase. | 2 months | 
| Tracked Walking Activity: Cadence (steps per minute) | Average steps per minute recorded by Fitbit during VOICE intervention phase. | 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. | 2 months | 
| 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. | 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. | 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. | 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. | 1 month, 2 months, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peripheral artery disease, claudication, supervised exercise therapy, walking, quality of life