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临床试验/NCT02881398
NCT02881398已完成2 期

A Randomized Trial of Pocket-Echocardiography Integrated Mobile Health Device Assessments in Modern Structural Heart Disease Clinics

Sri Sathya Sai Institute of Higher Medical Sciences0 个研究点目标入组 253 人开始时间: 2014年8月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
253
主要终点
Time to definitive treatment with Valvuloplasty or Valve Replacement

研究概览

简要总结

The primary objective of this investigation was to assess the impact of new mobile health devices on health outcomes among patients with rheumatic and structural heart disease in a resource limited area. To achieve this aim the investigators utilized smartphone-connected devices such as the smartphone-ECG, activity monitors, connected blood pressure devices and pocket-sized and handheld ultrasound. The main question asked in this investigation is if mobile health assessments accelerates medical-decision-making and if it shortens the time to definitive therapy.

详细描述

A recent paradigm-shift in the global burden of cardiovascular diseases has been observed with a decreasing prevalence in industrialized nations and an increasing prevalence in resource limited areas. This problem is further compounded with resource-limited areas receiving a disproportionately low allocation of global resources including diagnostic tests and trained healthcare professionals. Such cardiovascular conditions include heart failure, coronary artery disease, atrial arrhythmias and hypertensive heart disease. Coupled with a rising epidemic of rheumatic and structural heart disease affecting over 15- million individuals in these regions creates an urgent need that requires innovative and scalable methods to improve population- health, methods that reduce the cost of care, and simultaneously improves outcomes.

The World Health Organization's Millennium Developmental Goals has recently reported a rise in cellular phone technologies with 7-Billion devices in active circulation. Parallel developments with the globalization of Internet-based communication and the emergence of new smartphone-connected mobile health (mHealth) devices are providing new methods for patients to remotely monitor their chronic conditions and for providers to improve healthcare delivery. These technologies include smartphone 'apps', wearable and wireless devices such as the smartphone-ECG, sensor-based technologies, pocket-sized ultrasound and miniaturized lab-on-a-chip technologies. Several design features of mHealth are well suited for use in resource-limited areas and used as a practitioner-based diagnostic tool including portability, lower cost, and simple to use form factors. Although an attractive method for new technology utilization, the impact of mHealth used as a practitioner-based clinical-decision-support tool on subsequent management and outcomes has not been previously evaluated.

Several barriers to effective healthcare exist in resource-limited areas that requires multidisciplinary collaborations between the community, medical centers, health workers and patients. Developing new digital programs with healthcare innovations in these regions brings together a collaboration of industry, researchers, engineers and information technology partners. In the aggregate, a cumulative effort across several disciplines is necessary in order to assess the feasibility, utility, and impact of new devices in resource constrained areas. The investigators describe a multidisciplinary and global effort across institutions in India and the United States. The investigators received support from international medical societies and device manufacturers to advance our knowledge for technology utilization and to improve healthcare access and outcomes for patients in resource limited areas.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
1 Year 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Symptomatic outpatients with a new or an established diagnosis of rheumatic and structural heart disease and included valvular disease, left/right ventricular failure, rheumatic valvular disease, congenital heart defects and included adult, pediatric, and pregnant patients. Patients with a prior valvuloplasty or valve replacement for structural heart disease were also included

排除标准

  • Exclusions included neonatal patients and those with an unstable hemodynamic status

结局指标

主要结局

Time to definitive treatment with Valvuloplasty or Valve Replacement

时间窗: Upto 12 months after enrollment

次要结局

  • Cardiovascular Hospitalization and/or Death(Upto 12 months after enrollment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Srikanth Sola

Additional Senior Consultant

Sri Sathya Sai Institute of Higher Medical Sciences

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