Verizon mHealth Solution for Elderly Underserved Patients With Peripheral Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- 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).
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Mobile Health Application Group 1
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.
干预措施: Fitbit Physical Activity Monitor (Other)
Mobile Health Application Group 1
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.
干预措施: mHealth Glucometer (Other)
Mobile Health Application Group 1
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.
干预措施: mHealth Blood Pressure (Other)
Usual Care Group 2
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.
结局指标
主要结局
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).
时间窗: Baseline and 12-week
peak VO2 mL/kg/min
次要结局
- Change in Medication Adherence scores as measured by the Morisky Medication Adherence Scale (MMAS-8)(Baseline and 12-week)
- Change in Peripheral Artery Disease (PAD) Health Aptitude scores on the Health Aptitude Questionnaire(Baseline and 12-week)
- Change in Smoking Habits scores on the PAD: Smoking Habit Questionnaire(Baseline and 12-week)
- Change in physical activity patterns (steps, time and distance)(Baseline and 12-week)
- Change score analysis in Blood Glucose measurements(Baseline and 12-week)
- Change in Quality of Life (QOL) scores on the Walking Impairment Questionnaire(Baseline and 12-week)
- Change score analysis in Systolic and Diastolic Blood Pressure measurements(Baseline and 12-week)
- Feasibility of this novel mobile health treatment strategy, as measured by patient satisfaction survey(12-week)
- Change score analysis in Body Mass Index measurements(Baseline and 12-week)
- Implementation of this novel mobile health treatment strategy, as measured by patient satisfaction(12-week)