A Mobile Health Intervention in Pulmonary Arterial Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Daily Step Count
研究概览
简要总结
This study proposes the use of a mobile health intervention (utilizing a smart phone app) to encourage increased exercise in PAH patients. The study will be a randomized trial to examine feasibility of an mHealth (mobile device) Fitbit Charge HR and cell phone application intervention to improve step counts and increase participants activity level as compared to no intervention. The Fitbit Charge Heart Rate (HR) monitors activity and the cell phone application provides encouragement notifications to half the subjects while the other half do not receive encouragements.
详细描述
Patients with pulmonary arterial hypertension (PAH) have severely reduced exercise capacity and reduced quality of life. At diagnosis, most PAH patients are New York Heart Association (NYHA) functional class III with symptoms of fatigue and shortness of breath with less than ordinary activity. Physical activity confers multiple benefits relevant to PAH pathophysiology including improvements in endothelial function, energy metabolism, and right ventricular (RV) function. Increasing physical activity is highly efficacious in PAH, resulting in six-minute walk distance (6MWD) improvement that exceeds the effect of medications.
The goal of this proposal is to adapt and test the feasibility of our mHealth intervention to increase physical activity in a geographically diverse PAH population. In secondary aims, we will assess conventional PAH trial outcomes (6MWD, quality of life) and physiologic mechanisms by which increasing activity may improve exercise capacity.
The investigator hypothesizes that an mHealth intervention is feasible and will increase physical activity in subjects with PAH. This study proposes a randomized trial of unblinded step tracking with smart texts tracking for 12 weeks. Participants will wear a display-free triaxial accelerometer, which will continuously transmit data to a compatible smartphone (owned by 75% of our PAH population). Efficacy endpoints have been selected to mirror FDA criteria for drug approval in PAH. The following aims will be tested:
Aim 1: To test the feasibility of an mHealth intervention to increase step counts in patients with PAH. Fifty PAH patients will be randomized to the mHealth intervention or usual activity for 12 weeks. The primary endpoint will be daily step count during Week 12. Secondary endpoints will assess step target achievement, daily activity time, and aerobic time. The fidelity of data collection and text transmission will also be assessed.
Aim 2: To examine the effect of an mHealth intervention on exercise capacity and quality of life. Participants will complete a six minute walk test and the emPHasis-10 questionnaire at baseline and 12 weeks. The primary endpoint will be six minute walk distance. Secondary endpoints will be emPHasis-10 quality of life scale score, Borg dyspnea score, and resting heart rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Investigators are blinded.
Study personnel conducting 6MWT and echo will be blinded.
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
- •Aged 18 or older.
- •Diagnosed with idiopathic, heritable, or associated (connective tissue disease, drugs, or toxins) pulmonary arterial hypertension (PAH) according to World Health Organization consensus recommendations.
- •Stable PAH-specific medication regimen for three months prior to enrollment. Subjects with only a single diuretic adjustment in the prior three months will be included.
- •Subjects must own a Bluetooth capable modern smartphone capable of receiving and sending text messages and an active data plan.
排除标准
- •Prohibited from normal activity due to wheelchair bound status, bed bound status, reliance on a cane/walker, activity-limiting angina, activity-limiting osteoarthritis, or other condition.
- •Diagnosis of PAH etiology other than idiopathic, heritable, or associated.
- •Forced vital capacity <70% predicted.
- •Functional class IV heart failure.
- •Requirement of > 1 diuretic adjustment in the prior three months.
- •Preferred form of activity is not measured by an activity tracker (swimming, yoga, ice skating, stair master, or activities on wheels such as bicycling or rollerblading).
结局指标
主要结局
Daily Step Count
时间窗: Baseline to 12 weeks
Change from baseline mean daily step count at week 12.
次要结局
- Total Lean Mass(Baseline to 12 weeks)
- Six Minute Walk Test Distance(Baseline to 12 weeks)
- Change From Baseline on the SF-36 Mental Component Summary (MCS) Score(Baseline to 12 weeks)
- Percentage of Days Participants Met Their Daily Step Count Goal(Baseline to 12 weeks)
- Change From Baseline at Week 12 in emPHasis-10 Questionnaire Score(Baseline to 12 weeks)
- Right Ventricle (RV) Strain(Baseline to 12 weeks)
- Change From Baseline to Week 12 in Borg Dyspnea Score(Baseline to 12 weeks)
- Resting Heart Rate(Baseline to 12 weeks)
- Minutes of Moderate-vigorous Activity(Baseline to 12 Weeks)
- Visceral Fat Volume(Baseline to Week 12)
- Daily Aerobic Time(Baseline to 12 weeks)
- Insulin Resistance(Baseline to 12 weeks)
- BNP(Baseline to 12 weeks)
- Change From Baseline on the SF-36 Physical Component Summary (PCS) Score(Baseline to 12 weeks)
研究者
Evan Brittain
Assistant Professor of Medicine
Vanderbilt University Medical Center