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

NCT03554564 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2019-11-29

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • University of Michigan

    lead OTHER

  • Wake Forest University

    collaborator OTHER

  • Vascular Cures

    collaborator OTHER

Principal Investigators

  • Matthew A. Corriere, M.D. · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-02
Primary Completion
2019-11-13
Completion
2019-11-13

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03554564 on ClinicalTrials.gov