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:10723261
- 负责人:
- 金额:$ 76.87万
- 依托单位:
- 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 2027-08-31
- 项目状态:未结题
- 来源:
- 关键词:
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.
摘要
患有肺动脉高压(PAH)的患者健康相关生活质量(HRQOL)和
运动能力受损。尽管已经批准了14种治疗方法,但大多数患者都会在十年内死亡。这可怕的一面
事实突出表明,有必要制定干预措施,改善高危人群的生活质量,特别是针对性机制
对现有的PAH疗法来说不是多余的。增加体力活动对PAH非常有效,
导致6分钟步行距离(6MWD)和HRQOL的改善通常超过
药物。以前的活动研究需要住院康复,这是不切实际的,很难维持,而且
对一种罕见疾病的可伸缩性很差。此外,帕金森病的康复通常不会得到保险的补偿
美国,强调需要替代方案来促进体力活动。此应用程序构建在
最近完成的,由美国国立卫生研究院资助的移动健康(MHealth)干预PAH的试点和可行性试验。在……里面
在飞行员中,受试者佩戴Fitbit设备,并被随机分成两组,一组是常规护理,另一组是全自动的智能护理
Text“干预。文本内容以行为改变理论为基础,针对每个受试者进行个性化。
每天向干预臂发送3次短信,并基于实时活动发送鼓励信息
数据。每个受试者都有一个个性化的步数目标,每4周增加20%。在…的末尾
12周后,干预组比对照组每天多走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个月的智能短信与常规护理的随机试验。我们将随机选择100名PAH患者
接受mHealth干预或常规护理。所有注册、监控和数据收集都将在以下位置远程进行
范德比尔特。我们将在全美范围内招收受试者,增加普适性。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
财团和肺动脉高压协会登记处。R61里程碑(第1年):IRB批准;
建立数据仓库;创建红帽数据库;数据使用协议;文本干预编程;
前10个科目招生。在目标1(主端点)中,我们将测试基于文本的mHealth的效果
使用PAH特定强调-10问卷对PAH患者的HRQOL进行干预。目标2(次要目标
终点),我们将测试mHealth干预对运动能力的影响,通过高度可行的
和可重复性的有监督的家庭6MWD测试。在一个探索性的目标中,我们将检查
及时对临床恶化进行干预(PAH治疗升级、PAH住院和
死亡)随机分组一年后。该提案将测试一种新的、高度可扩展且负担得起的mHealth
干预以改善PAH患者的临床有意义的结果。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Evan L Brittain其他文献
Aortic insufficiency following transcatheter aortic valve replacement is underestimated by echocardiography compared with cardiac MRI
- DOI:
10.1186/1532-429x-16-s1-o101 - 发表时间:
2014-01-16 - 期刊:
- 影响因子:
- 作者:
Wissam M Abdallah;Chris A Semder;Evan L Brittain;Michael T Baker;Lisa A Mendes;Marshall H Crenshaw;Joseph L Fredi;Mark A Robbins;Sonia L Scalf;William S Bradham;Sean G Hughes;Mark A Lawson;David X Zhao - 通讯作者:
David X Zhao
Evan L Brittain的其他文献
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{{ truncateString('Evan L Brittain', 18)}}的其他基金
Impact of Physical Activity, Sleep, and Genetic Background on Cardiovascular Risk in the All of Us Program
“我们所有人”计划中体力活动、睡眠和遗传背景对心血管风险的影响
- 批准号:
10795533 - 财政年份:2023
- 资助金额:
$ 76.87万 - 项目类别:
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 - 财政年份:2022
- 资助金额:
$ 76.87万 - 项目类别:
Network Medicine and Systems Pharmacology to Advance Precision Medicine in Combined Pulmonary Hypertension
网络医学和系统药理学推进联合肺动脉高压的精准医学
- 批准号:
10625481 - 财政年份:2022
- 资助金额:
$ 76.87万 - 项目类别:
Network Medicine and Systems Pharmacology to Advance Precision Medicine in Combined Pulmonary Hypertension
网络医学和系统药理学推进联合肺动脉高压的精准医学
- 批准号:
10467751 - 财政年份:2022
- 资助金额:
$ 76.87万 - 项目类别:
Effect of PDE5 Inhibition on Adipose Metabolism in Humans
PDE5 抑制对人体脂肪代谢的影响
- 批准号:
10557112 - 财政年份:2021
- 资助金额:
$ 76.87万 - 项目类别:
Effect of PDE5 Inhibition on Adipose Metabolism in Humans
PDE5 抑制对人体脂肪代谢的影响
- 批准号:
10333359 - 财政年份:2021
- 资助金额:
$ 76.87万 - 项目类别:
Clinical, Genetic, and Proteomic Risk Factors for Pulmonary Hypertension in Heart Failure
心力衰竭肺动脉高压的临床、遗传和蛋白质组学危险因素
- 批准号:
10163899 - 财政年份:2019
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Clinical, Genetic, and Proteomic Risk Factors for Pulmonary Hypertension in Heart Failure
心力衰竭肺动脉高压的临床、遗传和蛋白质组学危险因素
- 批准号:
9913572 - 财政年份:2019
- 资助金额:
$ 76.87万 - 项目类别:
Clinical, Genetic, and Proteomic Risk Factors for Pulmonary Hypertension in Heart Failure
心力衰竭肺动脉高压的临床、遗传和蛋白质组学危险因素
- 批准号:
10394320 - 财政年份:2019
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$ 76.87万 - 项目类别:
PDE5 Inhibition for Obesity-Related Cardiometabolic Dysfunction
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