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

NCT ID: NCT03554564

Last Updated: 2019-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-02
• Study Completion Date: 2019-11-13

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

VOICE/Fitbit

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).

Group Type: EXPERIMENTAL

VOICE/Fitbit

Intervention Type: BEHAVIORAL

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)

Daily self-reported exercise adherence

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.

Group Type: OTHER

Daily self-reported exercise adherence

Intervention Type: OTHER

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.

Interventions

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)

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Other Intervention Names

Digital health platform plus tracked exercise

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wake Forest University

OTHER

Sponsor Role: collaborator

Vascular Cures

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Matthew Corriere

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthew A. Corriere, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan - Vascular Surgery Section

Ann Arbor, Michigan, United States

Wake Forest Baptist Health

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

HUM00142561

Identifier Type: OTHER

Identifier Source: secondary_id

HUM00142561

Identifier Type: -

Identifier Source: org_study_id