Peripheral Artery DiseaseVOICENCT03554564
Project VOICE: Vascular Outcomes Improvement Through Collection of PatiEnt Reported Data
A study testing VOICE/Fitbit and Daily self-reported exercise adherence in people with Peripheral Artery Disease, run by University of Michigan at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- VOICE/Fitbit and Daily self-reported exercise adherence
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Aug 2018to 13 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- Inability to speak or read English
- Severe mental illness
- Inability to give informed consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Michigan - Vascular Surgery Section
Ann Arbor, Michigan, 48109
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
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.
Read the 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
- Being tested
- VOICE/Fitbit, Daily self-reported exercise adherence
- Keywords
- peripheral artery disease, claudication, supervised exercise therapy, walking, quality of life
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VOICE/FitbitBehavioural
Also called Digital health platform plus tracked exercise
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 adherenceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: Daily self-reported exercise adherence |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Secondary outcomes (9)
Tracked Walking Activity: Distance (meters)
Distance in kilometers/miles recorded by Fitbit during VOICE intervention phase.
Measured: 2 months
Tracked Walking Activity: Steps (count)
Number of steps recorded by Fitbit device during VOICE intervention phase.
Measured: 2 months
Tracked Walking Activity: Time (minutes)
Number of minutes/hours recorded by Fitbit during VOICE intervention phase.
Measured: 2 months
Tracked Walking Activity: Cadence (steps per minute)
Average steps per minute recorded by Fitbit during VOICE intervention phase.
Measured: 2 months
Sleep interruption (mean nightly frequency)
While in VOICE/Fitbit phase, user data is collected by the unit for each sleep cycle including sleep duration, schedule, and quality. The data collected also shows insight into the number of sleep disruptions, restless periods, and minutes awake. This will only be tracked and recorded using Fitbit for the duration of the VOICE/Fitbit intervention phase.
Measured: 2 months
PROMIS Pain Interference Short Form 6a (raw score, T-score conversion)
Patient-Reported Outcomes Measurement Information System designed to gauge the level to which pain interferes with the participant's social, work, and day-to-day household activities. This six-item assessment yields total values ranging from 4 (low) to 20 (high) based on reported severity of pain interference, within a seven day duration. This measure will be repeated three times across the study and the data will be analyzed to determine consistency, improvement, and/or deterioration of quality.
Measured: 1 month, 2 months, 6 months
PROMIS Physical Function Short Form 6b (raw score, T-score conversion)
Patient-Reported Outcomes Measurement Information System short form questionnaire designed to gauge the level to which the participant feels their disease limits their ability to perform daily tasks and activities, at the time of the assessment. This six-item questionnaire yields total values ranging from 6 to 30, with a higher score representing a higher level of functional ability. This measure will be repeated three times across the study and the data will be analyzed to determine consistency, improvement, and/or deterioration of quality.
Measured: 1 month, 2 months, 6 months
PROMIS Sleep Disturbance Short Form 4a (raw score, T-score conversion)
Patient-Reported Outcomes Measurement Information System is a short form questionnaire administered to participants to gauge sleep depth and quality, within a seven day duration. This nine-item assessment is a combination of items in which participants are asked to respond either affirmatively or negatively, and with a subset of questions scored on a numerical scale with a raw score ranging from 4 (low) to 20 (high). This measure will be repeated three times across the study and the data will be analyzed to determine consistency, improvement, and/or deterioration of quality.
Measured: 1 month, 2 months, 6 months
VascuQol-6
The Vascular Quality of Life Questionnaire, or VascuQoL-6, is a disease-specific instrument in which the participant is asked about their concerns, abilities, and activities, referencing the previous two-week time frame. Overall values can range from 6 to 24 for the VascuQoL-6, with a higher total sum representing better participant health. This measure will be repeated three times across the study and the data will be analyzed to determine consistency, improvement, and/or deterioration of quality.
Measured: 1 month, 2 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start2 Aug 2018
- Primary completion13 Nov 2019
- Study completion13 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, non-blinded crossover study
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Wake Forest University, Vascular Cures
- Responsible party
- Principal investigator, Matthew Corriere, University of Michigan
- Investigators
- Matthew A. Corriere, M.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03554564
- Sponsor's protocol ID
- HUM00142561
- Other IDs
- HUM00142561
- Acronym
- VOICE
- Status last verified
- Nov 2019
- First submitted
- 30 May 2018
- Last updated
- 29 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project VOICE: Vascular Outcomes Improvement Through Collection of PatiEnt Reported Data
- ClinicalTrials.gov ID
- NCT03554564
- Acronym / sponsor ID
- VOICE / HUM00142561
- Conditions
- Peripheral Artery Disease
- Keywords
- peripheral artery disease, claudication, supervised exercise therapy, walking, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Wake Forest University, Vascular Cures
- Study start
- 2 Aug 2018 (actual)
- Primary completion
- 13 Nov 2019 (actual)
- Study completion
- 13 Nov 2019 (actual)
- First posted
- 13 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, non-blinded crossover study
| Arm | Type | Receives |
|---|---|---|
| VOICE/Fitbit | Experimental | Behavioral: VOICE/FitbitVOICE 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). |
| Daily self-reported exercise adherence | Other | Other: Daily self-reported exercise adherenceUsual 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VOICE/FitbitAlso: Digital health platform plus tracked exerciseDuring 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) | Behavioural | VOICE/Fitbit |
| Daily self-reported exercise adherenceDuring 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. | Other | Daily self-reported exercise adherence |
Primary outcome
Walking adherence (days with walking exercise/total days per study period)
Time frame: 2 months
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.
9 secondary outcomes
Tracked Walking Activity: Distance (meters)
Time frame: 2 months
Tracked Walking Activity: Steps (count)
Time frame: 2 months
Tracked Walking Activity: Time (minutes)
Time frame: 2 months
Tracked Walking Activity: Cadence (steps per minute)
Time frame: 2 months
Sleep interruption (mean nightly frequency)
Time frame: 2 months
PROMIS Pain Interference Short Form 6a (raw score, T-score conversion)
Time frame: 1 month, 2 months, 6 months
PROMIS Physical Function Short Form 6b (raw score, T-score conversion)
Time frame: 1 month, 2 months, 6 months
PROMIS Sleep Disturbance Short Form 4a (raw score, T-score conversion)
Time frame: 1 month, 2 months, 6 months
VascuQol-6
Time frame: 1 month, 2 months, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew A. Corriere, M.D. principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VOICE/Fitbit and Daily self-reported exercise adherence in people with Peripheral Artery Disease, run by University of Michigan at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking adherence (days with walking exercise/total days per study period) (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2019.