A Randomized Trial of Pocket-Echocardiography Integrated Mobile Health Device Assessments in Modern Structural Heart Disease Clinics

Abstract

Objectives: This study sought to determine whether mobile health (mHealth) device assessments used as clinical decision support tools at the point-of-care can reduce the time to treatment and improve long-term outcomes among patients with rheumatic and structural heart diseases (SHD).

Background: Newly developed smartphone-connected mHealth devices represent promising methods to diagnose common diseases in resource-limited areas; however, the impact of technology-based care on long-term outcomes has not been rigorously evaluated.

Methods: A total of 253 patients with SHD were randomized to an initial diagnostic assessment with wireless devices in mHealth clinics (n = 139) or to standard-care (n = 114) in India. mHealth clinics were equipped with point-of-care devices including pocket-echocardiography, smartphone-connected-electrocardiogram blood pressure and oxygen measurements, activity monitoring, and portable brain natriuretic peptide laboratory testing. All individuals underwent comprehensive transthoracic echocardiography to assess the severity of SHD. The primary endpoint was the time to referral for therapy with percutaneous valvuloplasty or surgical valve replacement. Secondary endpoints included the probability of a cardiovascular hospitalization and/or death over 1 year.

Results: An initial mHealth assessment was associated with a shorter time to referral for valvuloplasty and/or valve replacement (83 ± 79 days vs. 180 ± 101 days; p <0.001) and was associated with an increased probability for valvuloplasty/valve replacement compared to standard-care (34% vs. 32%; adjusted hazard ratio: 1.54; 95% CI: 0.96 to 2.47; p = 0.07). Patients randomized to mHealth were associated with a lower risk of a hospitalization and/or death on follow-up (15% vs. 28%, adjusted hazard ratio: 0.41; 95% CI: 0.21 to 0.83; p = 0.013).

Conclusions: An initial mHealth diagnostic strategy was associated with a shorter time to definitive therapy among patients with SHD in a resource-limited area and was associated with improved outcomes. (A Randomized Trial of Pocket-Echocardiography Integrated Mobile Health Device Assessments in Modern Structural Heart Disease Clinics; NCT02881398).

Keywords: clinical trial; devices; mobile health; outcomes; pocket-echocardiography; structural heart diseases.