Heart Diseases Clinical Trial
Official title:
A Randomized Trial of Pocket-Echocardiography Integrated Mobile Health Device Assessments in Modern Structural Heart Disease Clinics
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
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