Clinical trial NCT02472561: 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
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Artery Disease
Keywords: Cardiology
Vascular
Peripheral Artery Disease
Artery
Mobile Health
Exercise
PAD
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Verizon Wireless
First posted: 2015-06-16
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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.

Primary outcomes:
measure: 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).
timeFrame: Baseline and 12-week
Secondary outcomes:
measure: Feasibility of this novel mobile health treatment strategy, as measured by patient satisfaction survey
timeFrame: 12-week
measure: Implementation of this novel mobile health treatment strategy, as measured by patient satisfaction
timeFrame: 12-week
measure: Change in physical activity patterns (steps, time and distance)
timeFrame: Baseline and 12-week
measure: Change score analysis in Body Mass Index measurements
timeFrame: Baseline and 12-week
measure: Change score analysis in Blood Glucose measurements
timeFrame: Baseline and 12-week
measure: Change in Medication Adherence scores as measured by the Morisky Medication Adherence Scale (MMAS-8)
timeFrame: Baseline and 12-week
measure: Change in Quality of Life (QOL) scores on the Walking Impairment Questionnaire
timeFrame: Baseline and 12-week
measure: Change in Peripheral Artery Disease (PAD) Health Aptitude scores on the Health Aptitude Questionnaire
timeFrame: Baseline and 12-week
measure: Change in Smoking Habits scores on the PAD: Smoking Habit Questionnaire
timeFrame: Baseline and 12-week
measure: Change score analysis in Systolic and Diastolic Blood Pressure measurements
timeFrame: Baseline and 12-week
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Manesh R Patel, MD
role: PRINCIPAL_INVESTIGATOR
References: