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

Peripheral Artery Disease Clinical Trial

Official title:

Verizon mHealth Solution for Elderly Underserved Patients With Peripheral Artery Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02472561
• Other study ID #: Pro00059885
• Status: Completed
• Phase: N/A
• First received: June 10, 2015
• Last updated: January 31, 2018
• Start date: July 2015
• Est. completion date: November 7, 2017

Study information

• Verified date: January 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 7, 2017
• Est. primary completion date: November 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Other:
• Fitbit Physical Activity Monitor
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.
• mHealth Glucometer
Blood Glucose: The participant will monitor their fasting blood glucose once per week by using an mHealth Glucometer and mobile app.
• mHealth Blood Pressure
Blood Pressure: The participant will monitor their blood pressure once per week by using an mHealth Blood Pressure cuff and mobile app.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Verizon Wireless

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Feasibility of this novel mobile health treatment strategy, as measured by patient satisfaction survey	Patient Satisfaction Survey	12-week
Secondary	Implementation of this novel mobile health treatment strategy, as measured by patient satisfaction	Patient Satisfaction Survey	12-week
Secondary	Change in physical activity patterns (steps, time and distance)	Steps, time and distance per week	Baseline and 12-week
Secondary	Change score analysis in Body Mass Index measurements	Ratio of height to weight	Baseline and 12-week
Secondary	Change score analysis in Blood Glucose measurements	Fasting Plasma Glucose and Hemoglobin A1-C	Baseline and 12-week
Secondary	Change in Medication Adherence scores as measured by the Morisky Medication Adherence Scale (MMAS-8)		Baseline and 12-week
Secondary	Change in Quality of Life (QOL) scores on the Walking Impairment Questionnaire		Baseline and 12-week
Secondary	Change in Peripheral Artery Disease (PAD) Health Aptitude scores on the Health Aptitude Questionnaire		Baseline and 12-week
Secondary	Change in Smoking Habits scores on the PAD: Smoking Habit Questionnaire		Baseline and 12-week
Secondary	Change score analysis in Systolic and Diastolic Blood Pressure measurements		Baseline and 12-week