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

NCT03554564 | Completed

• 1 other identifier: HUM00142561
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

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.

Conditions

Peripheral Artery Disease

Keywords

peripheral artery disease; claudication; supervised exercise therapy; walking; quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Tracked Walking Activity: Distance (meters)

  2 months

• Tracked Walking Activity: Steps (count)

  2 months

• Tracked Walking Activity: Time (minutes)

  2 months

• Tracked Walking Activity: Cadence (steps per minute)

  2 months

• Sleep interruption (mean nightly frequency)

  2 months

Other Outcomes (6)

• Grip Strength (kg)

  Baseline

• Ankle-Brachial Index

  Baseline

• Diagnostic Tests

  6 months

Study Arms (2)

VOICE/Fitbit

EXPERIMENTAL

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

Daily self-reported exercise adherence

OTHER

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

Interventions

VOICE/Fitbit 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)

Also known as: Digital health platform plus tracked exercise

VOICE/Fitbit

Daily self-reported exercise adherence 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.

Daily self-reported exercise adherence

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• Wake Forest University: collaborator
• Vascular Cures: collaborator

Study Sites (2)

University of Michigan - Vascular Surgery Section

Ann Arbor, Michigan, 48109, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication

Interventions

Voice

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Matthew A. Corriere, M.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized, non-blinded crossover study

Study Record Dates

• First Submitted: May 30, 2018
• First Posted: June 13, 2018
• Study Start: August 2, 2018
• Primary Completion: November 13, 2019
• Study Completion: November 13, 2019
• Last Updated: November 29, 2019

Record last verified: 2019-11

Locations

US (2)