Ignite Creation Date:
2024-05-06 @ 9:02 AM
Last Modification Date:
2024-10-26 @ 12:08 PM
Study NCT ID:
NCT02881398
Status:
COMPLETED
Last Update Posted:
2016-08-29
First Post:
2016-08-18
Brief Title:
Mobile Health in Structural Heart Disease
Sponsor:
Sri Sathya Sai Institute of Higher Medical Sciences
Organization:
Sri Sathya Sai Institute of Higher Medical Sciences
Study Overview
Official Title:
A Randomized Trial of Pocket-Echocardiography Integrated Mobile Health Device Assessments in Modern Structural Heart Disease Clinics
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ASEF-VALUES
Brief Summary:
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
Detailed Description:
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 Organizations 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
The World Health Organizations 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None