Heart Diseases, Rheumatic Heart Disease
Conditions
Keywords
Mobile Health, Telemedicine, Pocket-Echocardiography
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 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.
Interventions
DEVICEmHealth
After randomization and at the time of the initial encounter, study subjects are assessed at the point-of-care with mHealth devices that measure symptoms, functional status, and for structural abnormalities. These devices include activity monitoring for an assessment of a 6-minute walk test, smartphone connected blood pressure, oxymetry and ECG for functional assessments, and structural assessments with handheld-echocardiography and point-of-care BNP. Treatment decisions for an intervention with percutaneous valvuloplasty or valve replacement were performed based on the aggregate of these mHealth findings. Confirmation of the severity of structural heart disease on transthoracic echocardiography was performed on all participants.
OTHERStandard-Care
After randomization and at the time of the initial encounter, study subjects randomized to standard-care underwent a physical examination, 12-lead ECG, radiographic and laboratory tests as warranted and clinically required. Treatment decisions for percutaneous valvuloplasty or valve replacement were based on the aggregate of the standard-care findings. Confirmation of the severity of structural heart disease on transthoracic echocardiography was performed on all participants.
Sponsors
Sri Sathya Sai Institute of Higher Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Exclusions included neonatal patients and those with an unstable hemodynamic status
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to definitive treatment with Valvuloplasty or Valve Replacement | Upto 12 months after enrollment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular Hospitalization and/or Death | Upto 12 months after enrollment | Secondary outcomes included the occurrence of a cardiovascular hospitalization and/or death over 12-months |
Outcome results
None listed