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

Duke University

Status: Completed

Conditions: Peripheral Artery Disease

Treatments: Other: mHealth Glucometer; Other: Fitbit Physical Activity Monitor; Other: mHealth Blood Pressure

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02472561

Pro00059885

Details and patient eligibility

About

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.

Full 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).

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

Mobile Health Application Group 1

Experimental group

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.

Treatment:

Other: Fitbit Physical Activity Monitor

Other: mHealth Blood Pressure

Other: mHealth Glucometer

Usual Care Group 2

No Intervention group

Description:

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.