Verizon mHealth Solution for Patients With Peripheral Artery Disease (PAD)
NCT ID: NCT02472561
Last Updated: 2018-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2015-07-31
2017-11-07
Brief Summary
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By testing a novel mHealth intervention focused on lifestyle modification, this trial will address a critical evidence gap in the care of PAD patients. PAD patients are not eligible for cardiac rehabilitation and therefore struggle with unhealthy lifestyles, and these patients currently have no lifestyle-based care strategies to help them. The results of this study have the potential to lead to new sustainable and resource-efficient, lifestyle-based preventive care strategies for patients with stable PAD.
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Detailed Description
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The investigators may enroll up to 55 men and women being evaluated for leg pain from Duke PAD cardiovascular clinics or after lower extremity angioplasty in the Duke catheterization laboratory. Of the 55 men and women volunteers who may be initially consented, the investigators anticipate a portion (potentially 20%) may drop out during the study timeline, and approximately 45 are expected to complete this study. Following informed consent and baseline testing, the participants will be randomized (1.25:1.00) into either a mHealth (N=25) or usual care group (N=20) \[for comparison\] for a 12-week period. All patients will be evaluated for walking ability on a treadmill test, quality of life questionnaires, health literacy related to PAD and the most important risk factors specific to PAD (blood glucose if diabetic, daily physical activity and blood pressure).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Mobile Health Application Group 1
Participants will wear a Fitbit Physical Activity Monitor to objectively quantify physical activity patterns. Once a week (± 3 days) during the 12 week mHealth intervention patients will measure and download their blood pressure and blood glucose (if diabetic) by means of a mHealth blood pressure cuff and mHealth glucometer. Medication adherence will be measured at baseline and 12-weeks by the Morisky Medication Adherence Scale-8 (MMAS-8) questionnaire. Each participant will be provided with a electronic version of the book titled, "Your COMPLETE and EASY GUIDE to Understanding Peripheral Artery Disease"; patients will be asked to read approximately one chapter per week for educational purposes.
Fitbit Physical Activity Monitor
Physical Activity: The study team will provide an individualized goal of total number of steps to attain daily and will be monitored using a Fitbit activity tracker. The total daily step goal will be reviewed by study staff and modified at weeks 4 and 8.
mHealth Glucometer
Blood Glucose: The participant will monitor their fasting blood glucose once per week by using an mHealth Glucometer and mobile app.
mHealth Blood Pressure
Blood Pressure: The participant will monitor their blood pressure once per week by using an mHealth Blood Pressure cuff and mobile app.
Usual Care Group 2
Participants will follow standard care as ordered by their individual, treating physician. Each participant will be given a paperback copy of the book, "Your COMPLETE and EASY GUIDE to Understanding Peripheral Artery Disease". All participants will be contacted by study personnel in order to schedule visits at baseline and 12-weeks for the outcome assessments.
No interventions assigned to this group
Interventions
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Fitbit Physical Activity Monitor
Physical Activity: The study team will provide an individualized goal of total number of steps to attain daily and will be monitored using a Fitbit activity tracker. The total daily step goal will be reviewed by study staff and modified at weeks 4 and 8.
mHealth Glucometer
Blood Glucose: The participant will monitor their fasting blood glucose once per week by using an mHealth Glucometer and mobile app.
mHealth Blood Pressure
Blood Pressure: The participant will monitor their blood pressure once per week by using an mHealth Blood Pressure cuff and mobile app.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* A history of stable intermittent claudication for \>2 months, and an ABI \<0.9 at rest
* No contraindications to exercise training
* All subjects will be on the recommended regimen of statin and antiplatelet therapy
* Signed informed consent document indicating that the patient understands the purpose of and procedures required for the study and is willing to participate in the study
Exclusion Criteria
* Severe peripheral neuropathy
* Any condition other than PAD that limits walking for example arthritis or chronic obstructive pulmonary disease (COPD)
* Unstable angina, history of significant left main disease or three vessel coronary artery disease (\>70% stenosis, unprotected by grafts) or recent myocardial infarction (less than eight weeks)
* Chest pain during treadmill exercise which appears before the onset of claudication, or 2 mm ST depression during exercise regardless of the results of tests for myocardial ischemia
* Refusal or inability to give informed consent or inability or unwillingness to comply with the study requirements.
* Dementia that precludes ability to participate in and follow study protocols
* Enrollment in a clinical trial not approved for co-enrollment.
18 Years
ALL
No
Sponsors
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Verizon Wireless
INDUSTRY
Duke University
OTHER
Responsible Party
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Principal Investigators
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Manesh R Patel, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke University Medical Center
Durham, North Carolina, United States
Countries
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Other Identifiers
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Pro00059885
Identifier Type: -
Identifier Source: org_study_id
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