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

ASEF-VALUES Investigators

Research output: Contribution to journalArticle

10 Citations (Scopus)

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)

Original languageEnglish (US)
Pages (from-to)546-557
Number of pages12
JournalJACC: Cardiovascular Imaging
Volume11
Issue number4
DOIs
StatePublished - Apr 1 2018

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Telemedicine
Echocardiography
Heart Diseases
Equipment and Supplies
Point-of-Care Systems
Mobile Health Units
Hospitalization
Referral and Consultation
Clinical Decision Support Systems
Rheumatic Heart Disease
Brain Natriuretic Peptide
Long-Term Care
Surgical Instruments
India
Electrocardiography
Therapeutics
Oxygen
Blood Pressure
Technology

Keywords

  • clinical trial
  • devices
  • mobile health
  • outcomes
  • pocket-echocardiography
  • structural heart diseases

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

Cite this

A Randomized Trial of Pocket-Echocardiography Integrated Mobile Health Device Assessments in Modern Structural Heart Disease Clinics. / ASEF-VALUES Investigators.

In: JACC: Cardiovascular Imaging, Vol. 11, No. 4, 01.04.2018, p. 546-557.

Research output: Contribution to journalArticle

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title = "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",
author = "{ASEF-VALUES Investigators} and Bhavnani, {Sanjeev P.} and Srikanth Sola and David Adams and Ashwin Venkateshvaran and Dash, {P. K.} and Sengupta, {Partho P.} and Sanjeev Bhavnani and Srikanth Sola and Ashwin Venkateshvaran and David Adams and Dash, {P. K.} and Sengupta, {Partho P.} and Thomas Ryan and Jagat Narula and James Thomas and Roberto Lang and Patricia Pellikka and Voleti Choudhary and Iyer, {V. Ramnath} and Dash, {P. K.} and Banajit Barooah and Srikanth Sola and Reeta Varyani and Anand Lingan and Venkatesh Murugan and Prayaag Kini and Ashwin Venkateshvaran and N. Srinivas and Barooah, {Asha C.} and Subbarao, {G. V.R.} and C. Shivakumar and M. Subramaniyan and Sengupta, {Shantanu P.} and Manish Bansal and Abdul Rahaman and Patil, {Vijaysinh N.} and Kumar, {Narayana R.} and Gahlot, {Mohammad Y.} and Damani, {Imran M.} and Rahul Gulati and Joshi, {Shreedhar S.} and Sanjay Dubey and Jesu Krupa and Sara Irfan and Vidhyakar, {R. B.} and Narendra Bidarkar and Shantesh, {B. K.} and Chavan, {Swapna S.} and R. Chandramohan and Vijaya Kumar",
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TY - JOUR

T1 - A Randomized Trial of Pocket-Echocardiography Integrated Mobile Health Device Assessments in Modern Structural Heart Disease Clinics

AU - ASEF-VALUES Investigators

AU - Bhavnani, Sanjeev P.

AU - Sola, Srikanth

AU - Adams, David

AU - Venkateshvaran, Ashwin

AU - Dash, P. K.

AU - Sengupta, Partho P.

AU - Bhavnani, Sanjeev

AU - Sola, Srikanth

AU - Venkateshvaran, Ashwin

AU - Adams, David

AU - Dash, P. K.

AU - Sengupta, Partho P.

AU - Ryan, Thomas

AU - Narula, Jagat

AU - Thomas, James

AU - Lang, Roberto

AU - Pellikka, Patricia

AU - Choudhary, Voleti

AU - Iyer, V. Ramnath

AU - Dash, P. K.

AU - Barooah, Banajit

AU - Sola, Srikanth

AU - Varyani, Reeta

AU - Lingan, Anand

AU - Murugan, Venkatesh

AU - Kini, Prayaag

AU - Venkateshvaran, Ashwin

AU - Srinivas, N.

AU - Barooah, Asha C.

AU - Subbarao, G. V.R.

AU - Shivakumar, C.

AU - Subramaniyan, M.

AU - Sengupta, Shantanu P.

AU - Bansal, Manish

AU - Rahaman, Abdul

AU - Patil, Vijaysinh N.

AU - Kumar, Narayana R.

AU - Gahlot, Mohammad Y.

AU - Damani, Imran M.

AU - Gulati, Rahul

AU - Joshi, Shreedhar S.

AU - Dubey, Sanjay

AU - Krupa, Jesu

AU - Irfan, Sara

AU - Vidhyakar, R. B.

AU - Bidarkar, Narendra

AU - Shantesh, B. K.

AU - Chavan, Swapna S.

AU - Chandramohan, R.

AU - Kumar, Vijaya

PY - 2018/4/1

Y1 - 2018/4/1

N2 - 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)

AB - 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)

KW - clinical trial

KW - devices

KW - mobile health

KW - outcomes

KW - pocket-echocardiography

KW - structural heart diseases

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