Clinical trial NCT03554564: Project VOICE: Vascular Outcomes Improvement Through Collection of PatiEnt Reported Data
Official title: Project VOICE: Vascular Outcomes Improvement Through Collection of PatiEnt Reported Data
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Artery Disease
Keywords: peripheral artery disease
claudication
supervised exercise therapy
walking
quality of life
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Wake Forest University
name: Vascular Cures
First posted: 2018-06-13
Enrollment: 28
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, non-blinded crossover study
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Walking adherence (days with walking exercise/total days per study period)
timeFrame: 2 months
Secondary outcomes:
measure: Tracked Walking Activity: Distance (meters)
timeFrame: 2 months
measure: Tracked Walking Activity: Steps (count)
timeFrame: 2 months
measure: Tracked Walking Activity: Time (minutes)
timeFrame: 2 months
measure: Tracked Walking Activity: Cadence (steps per minute)
timeFrame: 2 months
measure: Sleep interruption (mean nightly frequency)
timeFrame: 2 months
measure: PROMIS Pain Interference Short Form 6a (raw score, T-score conversion)
timeFrame: 1 month, 2 months, 6 months
measure: PROMIS Physical Function Short Form 6b (raw score, T-score conversion)
timeFrame: 1 month, 2 months, 6 months
measure: PROMIS Sleep Disturbance Short Form 4a (raw score, T-score conversion)
timeFrame: 1 month, 2 months, 6 months
measure: VascuQol-6
timeFrame: 1 month, 2 months, 6 months
Other outcomes:
measure: Grip Strength (kg)
timeFrame: Baseline
measure: Ankle-Brachial Index
timeFrame: Baseline
measure: Diagnostic Tests
timeFrame: 6 months
measure: PAD treatment interventions
timeFrame: 6 months
measure: Walking goal (steps per day)
timeFrame: baseline
measure: Change in walking goal (steps per day)
timeFrame: 2 months
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan - Vascular Surgery Section
state: Michigan
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
Study officials:
affiliation: University of Michigan
name: Matthew A. Corriere, M.D.
role: PRINCIPAL_INVESTIGATOR
References: