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Verizon mHealth Solution for Patients With Peripheral Artery Disease (PAD)

Primary Purpose

Peripheral Artery Disease

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Fitbit Physical Activity Monitor

mHealth Glucometer

mHealth Blood Pressure

About this trial

This is an interventional prevention trial for Peripheral Artery Disease focused on measuring Cardiology, Vascular, Peripheral Artery Disease, Artery, Mobile Health, Exercise, PAD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adequate clinical stability has been achieved in the judgment of the investigator to allow participation in study assessments and the intervention
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:

Present or a past history of gangrene, impending limb loss or osteomyelitis
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.

Sites / Locations

Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mobile Health Application Group 1

Usual Care Group 2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

peak VO2 mL/kg/min

Secondary Outcome Measures

Feasibility of this novel mobile health treatment strategy, as measured by patient satisfaction survey

Patient Satisfaction Survey

Implementation of this novel mobile health treatment strategy, as measured by patient satisfaction

Patient Satisfaction Survey

Change in physical activity patterns (steps, time and distance)

Steps, time and distance per week

Change score analysis in Body Mass Index measurements

Ratio of height to weight

Change score analysis in Blood Glucose measurements

Fasting Plasma Glucose and Hemoglobin A1-C

Change in Medication Adherence scores as measured by the Morisky Medication Adherence Scale (MMAS-8)

Change in Quality of Life (QOL) scores on the Walking Impairment Questionnaire

Change in Peripheral Artery Disease (PAD) Health Aptitude scores on the Health Aptitude Questionnaire

Change in Smoking Habits scores on the PAD: Smoking Habit Questionnaire

Change score analysis in Systolic and Diastolic Blood Pressure measurements

Full Information

NCT ID

NCT02472561

First Posted

June 10, 2015

Last Updated

January 31, 2018

Sponsor

Duke University

Collaborators

Verizon Wireless

1. Study Identification

Unique Protocol Identification Number

NCT02472561

Brief Title

Verizon mHealth Solution for Patients With Peripheral Artery Disease (PAD)

Official Title

Verizon mHealth Solution for Elderly Underserved Patients With Peripheral Artery Disease

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

July 2015 (undefined)

Primary Completion Date

November 7, 2017 (Actual)

Study Completion Date

November 7, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

Collaborators

Verizon Wireless

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Artery Disease

Keywords

Cardiology, Vascular, Peripheral Artery Disease, Artery, Mobile Health, Exercise, PAD

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mobile Health Application Group 1

Arm Type

Experimental

Arm Description

Arm Title

Usual Care Group 2

Arm Type

No Intervention

Arm Description

Intervention Type

Other

Intervention Name(s)

Fitbit Physical Activity Monitor

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

mHealth Glucometer

Other Intervention Name(s)

Diabetics Only

Intervention Description

Blood Glucose: The participant will monitor their fasting blood glucose once per week by using an mHealth Glucometer and mobile app.

Intervention Type

Other

Intervention Name(s)

mHealth Blood Pressure

Intervention Description

Blood Pressure: The participant will monitor their blood pressure once per week by using an mHealth Blood Pressure cuff and mobile app.

Primary Outcome Measure Information:

Title

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).

Description

peak VO2 mL/kg/min

Time Frame

Baseline and 12-week

Secondary Outcome Measure Information:

Title

Feasibility of this novel mobile health treatment strategy, as measured by patient satisfaction survey

Description

Patient Satisfaction Survey

Time Frame

12-week

Title

Implementation of this novel mobile health treatment strategy, as measured by patient satisfaction

Description

Patient Satisfaction Survey

Time Frame

12-week

Title

Change in physical activity patterns (steps, time and distance)

Description

Steps, time and distance per week

Time Frame

Baseline and 12-week

Title

Change score analysis in Body Mass Index measurements

Description

Ratio of height to weight

Time Frame

Baseline and 12-week

Title

Change score analysis in Blood Glucose measurements

Description

Fasting Plasma Glucose and Hemoglobin A1-C

Time Frame

Baseline and 12-week

Title

Change in Medication Adherence scores as measured by the Morisky Medication Adherence Scale (MMAS-8)

Time Frame

Baseline and 12-week

Title

Change in Quality of Life (QOL) scores on the Walking Impairment Questionnaire

Time Frame

Baseline and 12-week

Title

Change in Peripheral Artery Disease (PAD) Health Aptitude scores on the Health Aptitude Questionnaire

Time Frame

Baseline and 12-week

Title

Change in Smoking Habits scores on the PAD: Smoking Habit Questionnaire

Time Frame

Baseline and 12-week

Title

Change score analysis in Systolic and Diastolic Blood Pressure measurements

Time Frame

Baseline and 12-week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adequate clinical stability has been achieved in the judgment of the investigator to allow participation in study assessments and the intervention 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: Present or a past history of gangrene, impending limb loss or osteomyelitis 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Manesh R Patel, MD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27705

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Verizon mHealth Solution for Patients With Peripheral Artery Disease (PAD)

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