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

Completed · Not applicable

Conditions studied: Peripheral Artery Disease

In brief

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.

Key facts

Study ID

NCT02472561

Run by

Duke University

People needed

22

Starts

2015-07-01

Expected to finish

2017-11-07

Last updated by the study team

2018-02-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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