The MObile Health InterVEntion in Pulmonary Arterial Hypertension (MOVE PAH) Study

肺动脉高压的移动健康干预 (MOVE PAH) 研究

基本信息

批准号：
10525960
负责人：
Evan L Brittain
金额：
$ 77.31万
依托单位：
VANDERBILT UNIVERSITY MEDICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-09-01 至 2023-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10525960
关键词：
Activities of Daily Living Adipose tissue Adverse event Age Agreement Behavioral Cardiopulmonary rehabilitation Cellular Phone Cessation of life Clinical Collection Data Data Collection Databases Devices Dropout Effectiveness Enrollment Event Exercise Funding Goals Home Hospitalization Impairment Individual Inpatients Institutional Review Boards Insurance Intervention Link Measures Monitor Outcome Outcome Measure Participant Patient Outcomes Assessments Patients Pharmaceutical Preparations Physical Fitness Physical activity Population Process Psychology Publishing Pulmonary Hypertension Quality of life Questionnaires Randomized Rare Diseases Registries Rehabilitation therapy Reproducibility Right Ventricular Function Risk Secondary to Supervision Testing Text Text Messaging Theory of Change Time United States United States National Institutes of Health Visceral Walking arm base cohort cost exercise capacity experience feasibility trial fitbit health related quality of life home test improved innovation intervention effect mHealth novel pilot trial primary endpoint pulmonary arterial hypertension randomized trial safety and feasibility secondary endpoint sex text messaging intervention treatment arm treatment as usual

项目摘要

ABSTRACT Patients with pulmonary arterial hypertension (PAH) have reduced health related quality of life (HRQOL) and impaired exercise capacity. Despite fourteen approved therapies, most patients die within ten years. This grim fact underscores the need to develop interventions that improve HRQOL, particularly targeting mechanisms that are non-redundant to existing PAH therapies. Increasing physical activity is highly efficacious in PAH, resulting in six-minute walk distance (6MWD) and HRQOL improvement that often exceeds the effect of medications. Prior activity studies required inpatient rehabilitation, which is impractical, hard to sustain, and poorly scalable to a rare disease. Moreover, rehabilitation for PAH is not typically reimbursed by insurance in the United States, highlighting the need for alternatives to promote physical activity. This application builds on a recently-completed, NIH-funded pilot and feasibility trial of a mobile health (mHealth) intervention in PAH. In the pilot, subjects wore a Fitbit device and were randomized to either usual care or a fully automated “smart text” intervention. Text content was based on behavioral change theory and personalized to each subject. Texts were sent to the intervention arm 3 times/day with encouraging messages based on real-time activity data. Each subject had a personalized step count target which increased by 20% every 4 weeks. At the end of 12 weeks, the intervention arm took 1019 more steps per day than the control arm, an increase of 20% over baseline. We now hypothesize that increasing step counts will improve HRQOL in patients with PAH. We propose a randomized trial of smart texts versus usual care for 6 months. We will randomize 100 PAH patients to the mHealth intervention or usual care. All enrollment, monitoring, and data collection will occur remotely at Vanderbilt. We will enroll subjects across the United States, increasing generalizability. Our enrollment targets are feasible because we are supported by two large, existing PAH cohorts – the NIH-funded PVDOMICS Consortium and the Pulmonary Hypertension Association Registry. R61 Milestones (Year 1): IRB approval; establish DSMB; create REDCap database; Data Use Agreements; programming of text intervention; enrollment of first 10 subjects. In Aim 1 (primary endpoint), we will test the effect of a text-based mHealth intervention on HRQOL in PAH using the PAH-specific emPHasis-10 questionnaire. In Aim 2 (secondary endpoint), we will test the effect of an mHealth intervention on exercise capacity, measured by a highly feasible and reproducible supervised home-based 6MWD test. In an exploratory aim, we will examine the effect of the intervention on time to clinical worsening (composite of PAH therapy escalation, PAH hospitalization, and death) one year after randomization. This proposal will test a novel, highly scalable, and affordable mHealth intervention to improve clinically meaningful outcomes in patients with PAH.

抽象的肺动脉高压 (PAH) 患者的健康相关生活质量 (HRQOL) 降低，并且尽管有十四种已获批准的治疗方法，但大多数患者都会在十年内死亡。事实强调需要制定改善 HRQOL 的干预措施，特别是针对性机制与现有的 PAH 疗法无关，增加体力活动对 PAH 非常有效，导致六分钟步行距离 (6MWD) 和 HRQOL 的改善往往超过了先前的活动研究需要住院康复，这是不切实际的、难以维持的，并且此外，PAH 的康复通常无法通过保险报销。美国，强调需要替代品来促进身体活动。最近完成的一项由 NIH 资助的移动健康 (mHealth) 干预肺动脉高压的试点和可行性试验。在飞行员中，受试者佩戴了 Fitbit 设备，并被随机分配到常规护理组或全自动“智能设备”组。文本”干预。文本内容基于行为改变理论并针对每个主题进行个性化。每天向干预组发送 3 次短信，其中包含基于实时活动的鼓励信息每个受试者都有一个个性化的步数目标，每 4 周增加 20%。 12 周后，干预组每天比对照组多走 1019 步，比对照组增加了 20% 我们现在正在寻求增加步数将改善 PAH 患者的 HRQOL。提出一项为期 6 个月的智能文本与常规护理的随机试验我们将随机抽取 100 名 PAH 患者。移动医疗干预或常规护理的所有登记、监测和数据收集都将远程进行。范德比尔特。我们将在美国各地招收科目，提高我们的招收目标的普遍性。是可行的，因为我们得到了两个现有的大型 PAH 群体的支持——NIH 资助的 PVDOMICS 联盟和肺动脉高压协会登记处 R61 里程碑（第一年）：IRB 批准；建立DSMB；创建文本干预数据使用协议；在目标 1（主要终点）中，我们将测试基于文本的移动医疗的效果。使用 PAH 特异性 emPHasi-10 问卷对 PAH 进行 HRQOL 干预（目标 2）（次要）。终点），我们将测试移动健康干预对运动能力的影响，通过高度可行的方法来衡量和可重复的监督家庭 6MWD 测试在探索性目标中，我们将检查 6MWD 的效果。对临床恶化及时进行干预（包括 PAH 治疗升级、PAH 住院治疗和死亡）随机化一年后该提案将测试一种新颖的、高度可扩展且负担得起的移动医疗。干预以改善 PAH 患者的临床有意义的结果。