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Trial record 1 of 1 for:    NCT02881398
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Mobile Health in Structural Heart Disease (ASEF-VALUES)

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ClinicalTrials.gov Identifier: NCT02881398
Recruitment Status : Completed
First Posted : August 29, 2016
Last Update Posted : August 29, 2016
Sponsor:
Information provided by (Responsible Party):
Srikanth Sola, Sri Sathya Sai Institute of Higher Medical Sciences

Tracking Information
First Submitted Date  ICMJE August 18, 2016
First Posted Date  ICMJE August 29, 2016
Last Update Posted Date August 29, 2016
Study Start Date  ICMJE August 2014
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 23, 2016)
Time to definitive treatment with Valvuloplasty or Valve Replacement [ Time Frame: Upto 12 months after enrollment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2016)
Cardiovascular Hospitalization and/or Death [ Time Frame: Upto 12 months after enrollment ]
Secondary outcomes included the occurrence of a cardiovascular hospitalization and/or death over 12-months
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mobile Health in Structural Heart Disease
Official Title  ICMJE A Randomized Trial of Pocket-Echocardiography Integrated Mobile Health Device Assessments in Modern Structural Heart Disease Clinics
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Rheumatic Heart Disease
  • Heart Diseases
Intervention  ICMJE
  • Device: mHealth
    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.
  • Other: Standard-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.
Study Arms  ICMJE
  • Experimental: mHealth
    Each participant randomized to a mHealth assessment were evaluated with: (1) structural abnormalities with handheld-echocardiography (Vscan®, General Electric Healthcare); (2) vital signs with smartphone-connected oxymetry and blood pressure monitors (iHealthLabs®); (3) functional assessments on a 6-minute walk test with a trial-axial activity monitor (Ozeri®); (4) cardiac rhythm abnormalities with smartphone-connected- iECG (AliveCor®) and; (5)point-of-care testing with fingerstick B-type natriuretic peptide (Alere). All study participants then underwent a comprehensive transthoracic echocardiogram for anatomical assessments of the severity of rheumatic and structural heart disease prior to percutaneous valvuloplasty or a surgical valve replacement.
    Intervention: Device: mHealth
  • Active Comparator: Standard-Care
    Each participant randomized to a standard-assessment were evaluated with the resource available at the institution including a physical examination,12 lead-ECG, radiographic, laboratory testing as clinically required. All study participants underwent a comprehensive transthoracic echocardiogram for anatomical assessments of the severity of rheumatic and structural heart disease prior to percutaneous valvuloplasty or a surgical valve replacement.
    Intervention: Other: Standard-Care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 23, 2016)
253
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02881398
Other Study ID Numbers  ICMJE ASEF-VALUES
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Data will be made available to requesting investigators and 6 months after publication
Responsible Party Srikanth Sola, Sri Sathya Sai Institute of Higher Medical Sciences
Study Sponsor  ICMJE Sri Sathya Sai Institute of Higher Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Srikanth Sola, MD Sri Sathya Sai Institute of Higher Medical Sciences
Study Director: Sanjeev Bhavnani, MD Scripps Clinic and Reseach Institute
Principal Investigator: Partho Sengupta, MD Icahn School of Medicine at Mt. Sinai
PRS Account Sri Sathya Sai Institute of Higher Medical Sciences
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP