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Assessing the impact of mobile health technologies in resource limited areas

A Randomized Trial of Mobile Health Device Assessments in Structural Heart Disease Clinics

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN61479659
Enrollment
286
Registered
2016-08-29
Start date
2014-08-10
Completion date
Unknown
Last updated
2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

1. Rheumatic Heart Disease 2. Structural Heart Disease Circulatory System 1. Rheumatic Heart Disease 2. Structural Heart Disease

Interventions

Consecutive subjects are randomly assigned to an initial evaluation with mHealth or to standard-care. Study subjects are evaluated in either one of 5-mHealth or 5-standard-care sites.

Sponsors

American Society of Echocardiography
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Symptomatic outpatients with a new or an established diagnosis of rheumatic and structural heart disease, including valvular disease, left/right ventricular failure, rheumatic valvular disease, congenital heart defects 2. Adult, pediatric, and pregnant patients 3. Patients with a prior valvuloplasty or valve replacement for structural heart disease can also be included

Exclusion criteria

Exclusion criteria: 1. Neonatal patients 2. Those with an unstable hemodynamic status

Design outcomes

Primary

MeasureTime frame
Time to definitive treatment with valvuloplasty or valve replacement over 12-months is determined at the time of a healthcare encounter for valvuloplasty or valve replacement through monthly medical record review.

Secondary

MeasureTime frame
Occurrence of a cardiovascular hospitalization and/or death over 12-months is determined via monthly medical record review, community health worker visitation to the home, and text message follow up with the patient and care giver inquiring about a hospitalization and/or death.

Countries

India

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026