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

University of Michigan

Status: Completed

Conditions: Peripheral Artery Disease

Treatments: Other: Daily self-reported exercise adherence; Behavioral: VOICE/Fitbit

Study type: Interventional

Funder types: Other

Identifiers

NCT03554564

HUM00142561 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

VOICE/Fitbit

Experimental group

Description:

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).

Treatment:

Behavioral: VOICE/Fitbit

Daily self-reported exercise adherence

Other group

Description:

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.

Treatment:

Other: Daily self-reported exercise adherence