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Mobile Health in Structural Heart Disease

NCT02881398 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 253

Last updated 2016-08-29

No results posted yet for this study

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.

Conditions

  • Rheumatic Heart Disease
  • Heart Diseases

Interventions

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.

Sponsors & Collaborators

  • Sri Sathya Sai Institute of Higher Medical Sciences

    lead OTHER

Principal Investigators

  • Srikanth Sola, MD · Sri Sathya Sai Institute of Higher Medical Sciences

  • Sanjeev Bhavnani, MD · Scripps Clinic and Reseach Institute

  • Partho Sengupta, MD · Icahn School of Medicine at Mt. Sinai

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-10-31
Completion
2016-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02881398 on ClinicalTrials.gov