Peripheral Artery Disease Clinical Trial
Official title:
Verizon mHealth Solution for Elderly Underserved Patients With Peripheral Artery Disease
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.
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).
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05712395 -
The Effects of a Novel, Non-ischemic and Pain-free Exercise Intervention in Peripheral Artery Disease
|
N/A | |
Active, not recruiting |
NCT04534257 -
Prospective Registry to Investigate the Safety and Efficacy of the Treatment With the Selution Sirolimus Drug Coated Balloon in TASC C and D Atheroma-occlusive Infra-Inguinal Disease in Patients With Chronic Limb Threatening Ischemia From Singapore
|
N/A | |
Recruiting |
NCT04511234 -
Sirolimus Coated Balloon Versus Standard Balloon for SFA and Popliteal Artery Disease
|
N/A | |
Recruiting |
NCT03506633 -
Impacts of Mitochondrial-targeted Antioxidant on Peripheral Artery Disease Patients
|
N/A | |
Active, not recruiting |
NCT03506646 -
Dietary Nitrate Supplementation and Thermoregulation
|
N/A | |
Completed |
NCT02554266 -
Registry Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon for Treatment of BTK Arteries
|
||
Completed |
NCT03921905 -
Peripheral Artery Disease in Patients With Stable Coronary Artery Disease in General Practice: Prevalence, Management and Clinical Outcomes.
|
||
Not yet recruiting |
NCT06369350 -
Vitamin B6 on Exercise Pressor Reflex on Leg Ischemia-reperfusion
|
Early Phase 1 | |
Recruiting |
NCT04545268 -
Prehabilitation for Cardiac Surgery in Patients With Reduced Exercise Tolerance
|
N/A | |
Recruiting |
NCT02389023 -
Comparison of Prevena Negative Pressure Incision Management System vs. Standard Dressing After Vascular Surgery
|
N/A | |
Completed |
NCT02542267 -
In-Stent Restenosis Post-Approval Study
|
N/A | |
Completed |
NCT02539940 -
Elutax-SV Drug-eluting Balloons for Below-the-knee Treatment
|
||
Completed |
NCT02522884 -
Tack Optimized Balloon Angioplasty Study of the Tack Endovascular Systemâ„¢ in Femoropoliteal Arteries
|
N/A | |
Completed |
NCT02563535 -
Evaluation of the Use of ACOTEC Drug-Eluting Balloon Litos ® in Below-The-Knee Arteries to Treat Critical Limb Ischemia
|
Phase 4 | |
Completed |
NCT02145065 -
First-in-man Evaluation of a Novel, Microcrystalline Paclitaxel Coated Balloon for Treatment of Femoropopliteal Artery Disease (PAX-r)
|
N/A | |
Completed |
NCT02262949 -
A Prospective Study of the Bard® LifeStent® Solo Vascular Stent System
|
N/A | |
Completed |
NCT02228564 -
BARD® Study of LIFESTREAMâ„¢ Balloon Expandable Covered Stent Treating Iliac Arterial Occlusive Disease
|
N/A | |
Completed |
NCT01743872 -
Optical Imaging Measurement of Intravascular Solution Efficacy Trial
|
N/A | |
Recruiting |
NCT01424020 -
Walking Estimated Limitation Calculated by History - Study 2
|
Phase 4 | |
Active, not recruiting |
NCT01597453 -
NOR-SYS: The Norwegian Stroke in the Young Study
|
N/A |