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.

摘要 肺动脉高压（PAH）患者的健康相关生活质量（HRQOL）降低， 运动能力受损。尽管有14种被批准的治疗方法，但大多数患者在10年内死亡。这种严峻 这一事实强调了开发改善HRQOL的干预措施的必要性，特别是针对机制 对现有PAH治疗来说是非冗余的。增加体力活动对PAH非常有效， 导致六分钟步行距离（6 MWD）和HRQOL的改善，通常超过 药物治疗以前的活动研究需要住院康复，这是不切实际的，难以维持， 很难扩展到一种罕见疾病。此外，PAH的康复通常不会得到保险的补偿， 美国，强调需要替代品来促进身体活动。此应用程序构建于 最近完成的一项由NIH资助的针对PAH的移动的健康（mHealth）干预的试点和可行性试验。在 受试者戴上Fitbit设备，随机接受常规护理或全自动“智能”护理。 文本”干预。文本内容是基于行为改变理论和个性化的每个主题。 每天3次向干预组发送文本，并根据实时活动发送鼓励信息 数据每名受试者都有一个个性化的步数目标，每4周增加20%。结束时 12周后，干预组每天比对照组多走1019步，比对照组增加20%。 基线。我们现在假设增加步数将改善PAH患者的HRQOL。我们 建议进行一项为期6个月的智能文本与常规护理的随机试验。我们将随机分配100例PAH患者 移动健康干预或常规护理。所有入组、监查和数据收集将在以下地点远程进行： 范德比尔特。我们将在美国各地招募受试者，增加普遍性。我们的招生目标 是可行的，因为我们得到了两个大型的现有PAH队列的支持-NIH资助的PVDOMICS 联盟和肺动脉高压协会登记处。R61 Milestone（第1年）：IRB批准; 建立DSMB;创建REDCap数据库;数据使用协议;文本干预编程; 入选前10名受试者。在目标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emPHasis-10问卷对PAH患者的HRQOL进行干预。在目标2（中学） 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 和可重复的监督家庭6 MWD测试。在一个探索性的目标，我们将研究的影响， 对至临床恶化时间的干预（PAH治疗递增、PAH住院和 死亡）。这项提案将测试一种新颖的、高度可扩展的、负担得起的移动医疗 改善PAH患者临床有意义结局的干预。