NCT03554564

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Peripheral Artery Disease

Interventions

Type	Name	Description
BEHAVIORAL	VOICE/Fitbit	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)
OTHER	Daily self-reported exercise adherence	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.

Timeline

• Start date: 2018-08-02
• Primary completion: 2019-11-13
• Completion: 2019-11-13
• First posted: 2018-06-13
• Last updated: 2019-11-29

Locations

2 sites across 1 country: United States