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Using mHealth tools to improve access, coverage and treatment of uninsured people with high cardiovascular disease risk in Argentina: a study protocol for a pragmatic cluster randomised trial
  1. Shafika Abrahams-Gessel1,
  2. Andrea Beratarrechea2,
  3. Vilma Irazola2,
  4. Laura Gutierrez2,
  5. Daniela Moyano2,
  6. Ariel Fernandez2,
  7. Alvaro Ciganda2,
  8. Leo Anthony Celis3,
  9. Eric Winkler3,
  10. Adolfo Rubinstein4,
  11. Thomas A Gaziano1,5
  1. 1 Center for Health Decision Science, Harvard University T.H. Chan School of Public Health, Boston, Massachusetts, USA
  2. 2 Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina
  3. 3 Institute for Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA
  4. 4 Ministry of Health of Argentina, Buenos Aires, Argentina
  5. 5 Department of Cardiovascular Medicine, Brigham and Women’s Hospital, Boston, Massachusetts, USA
  1. Correspondence to Dr Shafika Abrahams-Gessel, Center for Health Decision Science, Harvard TH Chan School of Public Health, Boston, MA 02115, USA; sabraham{at}hsph.harvard.edu and Dr Thomas A Gaziano, Department of Cardiovascular Medicine, Brigham and Women’s Hospital, Boston, MA 02115, USA; tgaziano{at}bwh.harvard.edu

Abstract

Introduction Cardiovascular disease (CVD) accounts for approximately one-third of Argentina’s deaths. Despite government provision of free primary care health services to the uninsured population, with a focus on non-communicable diseases, screening and management of those with high CVD risk at primary care clinics (PCCs) remain low.

Methods and analysis This pragmatic cluster randomised trial will take place in two provinces of Argentina and will recruit 740 participants. Eight PCCs will be randomised to either the intervention or current practice arm. Community health workers (CHWs) in the intervention arm will be trained to use a set of integrated mHealth tools (a validated risk screening tool mobile application; electronic scheduling system using wireless access to PCCs; and educational text messages) to screen for CVD and to schedule appointments with primary care providers for persons with high CVD risk (≥10%). The primary aims of this study are to determine if the use of mHealth tools will (1) increase attendance of first appointments scheduled by CHWs for persons determined to have high risk for CVD during screening and, (2) lead to an increase in follow-up visits at PCCs by high risk patients. Secondary outcomes include assessing the proportion of high-risk patients receiving appropriate medications and a cost-effective analysis of the intervention.

Ethics and dissemination This study has been approved by the Institutional Review Boards at Partners/Brigham and Women’s Hospital (USA) and the Hospital Italiano de Buenos Aires (Argentina). The open-source software for the mHealth tools will be made publicly available at the end of the study.

Trial registration number NCT02913339.

  • mhealth
  • cardiovascular
  • primary care
  • prevention

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Footnotes

  • Contributors TAG, AR, AB, SA-G and VI created the concept for the study and the protocol. AF, AC, LAC and EW developed the mHealth tools. AB, LG, DM, AH and AC were responsible for the design, collection and implementation of data collection. SA-G wrote the primary draft of the manuscript with input from AB and DM. TAG, AB, VI, AF, AC, LAC, EW and LG all reviewed and provided feedback on the final manuscript.

  • Funding This study was funded in full by the National Institutes of Health/Fogarty International Center (5R21TW01073).

  • Disclaimer The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

  • Competing interests None declared.

  • Patient consent Obtained.

  • Ethics approval This trial has been registered with ClinicalTrials.Gov (NCT02913339). A CONSORT checklist for reporting randomised trials has been completed for this study. The protocol complies with the requirements of the Ethics Committee (IRB) of the Hospital Italiano de Buenos Aires and the IRB at the Brigham & Women’s Hospital, Boston.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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