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
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
- 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:
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
- 资助金额:
$ 76.87万 - 项目类别:
PDE5 Inhibition for Obesity-Related Cardiometabolic Dysfunction
PDE5 抑制治疗肥胖相关的心脏代谢功能障碍
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9113813 - 财政年份:2016
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$ 76.87万 - 项目类别:
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