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

• 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
• 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

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）患者的生活质量降低（HRQOL）和 运动能力受损。尽管有14种批准的疗法，但大多数患者在十年内死亡。这个严峻的 事实强调了开发改善HRQOL的干预措施的需求，尤其是针对机制 对于现有的PAH疗法而言是非冗余的。体育锻炼的增加在PAH中高效， 导致步行六分钟的距离（6MWD）和HRQOL改善通常超过 药物。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 对罕见疾病的可扩展性不佳。此外，PAH的康复通常不会由保险偿还 美国强调需要促进体育锻炼的替代方案。此应用程序建立在 最近完成的NIH资助的飞行员和移动健康（MHealth）干预PAH的可行性试验。在 飞行员，受试者戴了Fitbit设备，并随机分配给通常的护理或全自动的“智能 文本干预。文本内容基于行为改变理论，并对每个主题进行个性化。 根据实时活动，文本被发送3次，每天3次，令人鼓舞的消息 数据。每个受试者的个性化步骤计数目标每4周增加20％。在 12周，干预臂每天的步骤比控制臂多1019个，增加了20％ 基线。现在，我们假设增加的步骤计数将改善PAH患者的HRQOL。我们 提议智能文本的随机试验与通常的护理6个月。我们将随机分别100名PAH患者 进行MHealth干预或通常的护理。所有注册，监控和数据收集都将在 范德比尔特。我们将在美国各地注册受试者，从而提高普遍性。我们的入学目标 之所以可行，是因为我们得到了两个大型现有的PAH队列的支持 - NIH资助的Pvdomics 财团和肺动脉高压协会注册中心。 R61里程碑（1年）：IRB批准； 建立DSMB；创建REDCAP数据库；数据使用协议；文本干预的编程； 入学前10名受试者。在AIM 1（主要终点）中，我们将测试基于文本的MHealth的效果 使用PAH特异性重点10调查表对PAH中HRQOL的干预。在AIM 2（次级 终点），我们将测试MHealth干预对运动能力的影响，该锻炼能力是由高度可行的 以及可重现的基于家庭的6MWD测试。为了探索目的，我们将研究 临床担心的时间干预（PAH治疗升级，PAH住院和 随机化一年后死亡）。该建议将测试一部小说，高度扩展且负担得起的MHealth 干预措施以改善PAH患者的临床有意义的结果。