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

NCT02472561 | Completed DMC

• 1 other identifier: Pro00059885
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Artery Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline and 12-week

Secondary Outcomes (10)

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

  12-week

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

  12-week

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

  Baseline and 12-week

• Change score analysis in Body Mass Index measurements

  Baseline and 12-week

• Change score analysis in Blood Glucose measurements

  Baseline and 12-week

Study Arms (2)

Mobile Health Application Group 1

EXPERIMENTAL

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; Other: mHealth Glucometer; Other: mHealth Blood Pressure

Usual Care Group 2

NO INTERVENTION

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.

Interventions

Fitbit Physical Activity Monitor OTHER

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.

Mobile Health Application Group 1

mHealth Glucometer OTHER

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

Also known as: Diabetics Only

Mobile Health Application Group 1

mHealth Blood Pressure OTHER

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

Mobile Health Application Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Duke University: lead
• Verizon Wireless: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Motor Activity

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Behavior

Study Officials

• Manesh R Patel, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2015
• First Posted: June 16, 2015
• Study Start: July 1, 2015
• Primary Completion: November 7, 2017
• Study Completion: November 7, 2017
• Last Updated: February 5, 2018

Record last verified: 2018-01

Locations

US (1)