Verizon mHealth Solution for Patients With Peripheral Artery Disease (PAD)
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|ClinicalTrials.gov Identifier: NCT02472561|
Recruitment Status : Completed
First Posted : June 16, 2015
Last Update Posted : February 5, 2018
The purpose of this study is to understand the effects that a three month lifestyle-based mobile health (mHealth) peripheral artery disease (PAD) prevention program will have on improving physical activity, fitness, important PAD risk factors and quality of life (QOL) in patients with PAD.
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.
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Artery Disease||Other: Fitbit Physical Activity Monitor Other: mHealth Glucometer Other: mHealth Blood Pressure||Not Applicable|
This is a single-center, randomized trial designed to examine the hypothesis that a lifestyle-based mHealth peripheral artery disease (PAD) prevention program will improve physical activity, fitness, important PAD risk factors and quality of life (QOL).
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Verizon mHealth Solution for Elderly Underserved Patients With Peripheral Artery Disease|
|Study Start Date :||July 2015|
|Actual Primary Completion Date :||November 7, 2017|
|Actual Study Completion Date :||November 7, 2017|
Experimental: 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.
Other: 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.
Other: mHealth Glucometer
Blood Glucose: The participant will monitor their fasting blood glucose once per week by using an mHealth Glucometer and mobile app.
Other Name: Diabetics Only
Other: 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.
No Intervention: 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.
- Change in cardiovascular fitness level measured by change score analysis of peak Volume of Oxygen (pVO2mL/kg/min) consumption measured during a cardiopulmonary exercise test (CPET). [ Time Frame: Baseline and 12-week ]peak VO2 mL/kg/min
- Feasibility of this novel mobile health treatment strategy, as measured by patient satisfaction survey [ Time Frame: 12-week ]Patient Satisfaction Survey
- Implementation of this novel mobile health treatment strategy, as measured by patient satisfaction [ Time Frame: 12-week ]Patient Satisfaction Survey
- Change in physical activity patterns (steps, time and distance) [ Time Frame: Baseline and 12-week ]Steps, time and distance per week
- Change score analysis in Body Mass Index measurements [ Time Frame: Baseline and 12-week ]Ratio of height to weight
- Change score analysis in Blood Glucose measurements [ Time Frame: Baseline and 12-week ]Fasting Plasma Glucose and Hemoglobin A1-C
- Change in Medication Adherence scores as measured by the Morisky Medication Adherence Scale (MMAS-8) [ Time Frame: Baseline and 12-week ]
- Change in Quality of Life (QOL) scores on the Walking Impairment Questionnaire [ Time Frame: Baseline and 12-week ]
- Change in Peripheral Artery Disease (PAD) Health Aptitude scores on the Health Aptitude Questionnaire [ Time Frame: Baseline and 12-week ]
- Change in Smoking Habits scores on the PAD: Smoking Habit Questionnaire [ Time Frame: Baseline and 12-week ]
- Change score analysis in Systolic and Diastolic Blood Pressure measurements [ Time Frame: Baseline and 12-week ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02472561
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Manesh R Patel, MD||Duke University|