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Protocol for the mWellcare trial: a multicentre, cluster randomised, 12-month, controlled trial to compare the effectiveness of mWellcare, an mHealth system for an integrated management of patients with hypertension and diabetes, versus enhanced usual care in India
  1. Dilip Jha1,
  2. Priti Gupta1,
  3. Vamadevan S Ajay1,
  4. Devraj Jindal1,
  5. Pablo Perel2,
  6. David Prieto-Merino2,3,
  7. Pramod Jacob1,
  8. Jonathan Nyong2,
  9. Vidya Venugopal1,4,
  10. Kavita Singh1,5,
  11. Shifalika Goenka1,
  12. Ambuj Roy6,
  13. Nikhil Tandon5,
  14. Vikram Patel2,7,
  15. Dorairaj Prabhakaran1,2
  1. 1 Centre for Control of Chronic Conditions, Public Health Foundation of India, Gurgaon, India
  2. 2 Centre for Control of Chronic Conditions, London School of Hygiene and Tropical Medicine, London, UK
  3. 3 Applied Statistical Methods in Medical Research Group, Universidad Catolica San Antonio de Murcia, Murcia, Spain
  4. 4 Department of Epidemiology, University of Pittsburgh,Graduate School of Public Health, Pittsburgh, USA
  5. 5 Department of Endocrinology and Metabolism, Centre for Control of Chronic Conditions, All India Institute of Medical Sciences, New Delhi, India
  6. 6 Department of Cardiology, Centre for Control of Chronic Conditions, All India Institute of Medical Sciences, New Delhi, India
  7. 7 Department of Global Health and Social Medicine, Harvard Medical School, Boston, USA
  1. Correspondence to Dr Dorairaj Prabhakaran; dprabhakaran{at}ccdcindia.org

Abstract

Introduction Rising burden of cardiovascular disease (CVD) and diabetes is a major challenge to the health system in India. Innovative approaches such as mobile phone technology (mHealth) for electronic decision support in delivering evidence-based and integrated care for hypertension, diabetes and comorbid depression have potential to transform the primary healthcare system.

Methods and analysis mWellcare trial is a multicentre, cluster randomised controlled trial evaluating the clinical and cost-effectiveness of a mHealth system and nurse managed care for people with hypertension and diabetes in rural India. mWellcare system is an Android-based mobile application designed to generate algorithm-based clinical management prompts for treating hypertension and diabetes and also capable of storing health records, sending alerts and reminders for follow-up and adherence to medication. We recruited a total of 3702 participants from 40 Community Health Centres (CHCs), with ≥90 at each of the CHCs in the intervention and control (enhanced care) arms. The primary outcome is the difference in mean change (from baseline to 1 year) in systolic blood pressure and glycated haemoglobin (HbA1c) between the two treatment arms. The secondary outcomes are difference in mean change from baseline to 1 year in fasting plasma glucose, total cholesterol, predicted 10-year risk of CVD, depression, smoking behaviour, body mass index and alcohol use between the two treatment arms and cost-effectiveness.

Ethics and dissemination The study has been approved by the institutional Ethics Committees at Public Health Foundation of India and the London School of Hygiene and Tropical Medicine. Findings will be disseminated widely through peer-reviewed publications, conference presentations and other mechanisms.

Trial registration mWellcare trial is registered with Clinicaltrial.gov (Registration number NCT02480062; Pre-results) and Clinical Trial Registry of India (Registration number CTRI/2016/02/006641). The current version of the protocol is Version 2 dated 19 October 2015 and the study sponsor is Public Health Foundation of India, Gurgaon, India (www.phfi.org).

  • hypertension
  • diabetes
  • mHealth
  • decision support system
  • integrated management of chronic conditions

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

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Footnotes

  • Contributors DJ coordinated the study, developed the first draft and subsequent revision of manuscript. PG: technical coordination of the study and helped in development and revision of manuscript. VSA designed the study, providing overall supervision, reviewed of manuscript. DrJ contributed to development of mHealth solution and reviewed manuscript. PP contributed to development of intervention and reviewed manuscript. DP-M developed statistical analysis plan and reviewed manuscript. JN contributed to development of cost-effectiveness analysis plan, process indicators and reviewed manuscript. VV contributed to development of statistical analysis plan and reviewed manuscript. PJ contributed to development of information technology component of intervention and reviewed manuscript. KS developed of cost-effectiveness analysis plan and reviewed manuscript. SG developed process indicators and analysis plan and reviewed manuscript. AR contributed to development of intervention and reviewed manuscript. NT contributed to the design of the study, development of intervention and reviewed manuscript. VP contributed to the design of the study, development of intervention and reviewed manuscript. DP provided overall supervision, contributed to the design of the study, development of intervention and finalisation of manuscript.

  • Funding This work was supported by the Wellcome Trust (Grant Number 096735/A/11/Z). The funding source had no role in the design of this study and will not have any role during its execution, analyses, interpretation of the data or decision to submit results. However, if the mWellcare intervention is found to be effective in improving patient outcomes, the involving institutions – LSHTM, Wellcome Trust and PHFI – will commercialise the mWellcare system in a sustainable business model.

  • Competing interests None declared.

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

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