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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

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...

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Autores principales: Jha, Dilip, Gupta, Priti, Ajay, Vamadevan S, Jindal, Devraj, Perel, Pablo, Prieto-Merino, David, Jacob, Pramod, Nyong, Jonathan, Venugopal, Vidya, Singh, Kavita, Goenka, Shifalika, Roy, Ambuj, Tandon, Nikhil, Patel, Vikram, Prabhakaran, Dorairaj
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5724108/
https://www.ncbi.nlm.nih.gov/pubmed/28801393
http://dx.doi.org/10.1136/bmjopen-2016-014851
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author Jha, Dilip
Gupta, Priti
Ajay, Vamadevan S
Jindal, Devraj
Perel, Pablo
Prieto-Merino, David
Jacob, Pramod
Nyong, Jonathan
Venugopal, Vidya
Singh, Kavita
Goenka, Shifalika
Roy, Ambuj
Tandon, Nikhil
Patel, Vikram
Prabhakaran, Dorairaj
author_facet Jha, Dilip
Gupta, Priti
Ajay, Vamadevan S
Jindal, Devraj
Perel, Pablo
Prieto-Merino, David
Jacob, Pramod
Nyong, Jonathan
Venugopal, Vidya
Singh, Kavita
Goenka, Shifalika
Roy, Ambuj
Tandon, Nikhil
Patel, Vikram
Prabhakaran, Dorairaj
author_sort Jha, Dilip
collection PubMed
description 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).
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spelling pubmed-57241082017-12-19 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 Jha, Dilip Gupta, Priti Ajay, Vamadevan S Jindal, Devraj Perel, Pablo Prieto-Merino, David Jacob, Pramod Nyong, Jonathan Venugopal, Vidya Singh, Kavita Goenka, Shifalika Roy, Ambuj Tandon, Nikhil Patel, Vikram Prabhakaran, Dorairaj BMJ Open Cardiovascular Medicine 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). BMJ Publishing Group 2017-08-11 /pmc/articles/PMC5724108/ /pubmed/28801393 http://dx.doi.org/10.1136/bmjopen-2016-014851 Text en © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted. 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/
spellingShingle Cardiovascular Medicine
Jha, Dilip
Gupta, Priti
Ajay, Vamadevan S
Jindal, Devraj
Perel, Pablo
Prieto-Merino, David
Jacob, Pramod
Nyong, Jonathan
Venugopal, Vidya
Singh, Kavita
Goenka, Shifalika
Roy, Ambuj
Tandon, Nikhil
Patel, Vikram
Prabhakaran, Dorairaj
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Cardiovascular Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5724108/
https://www.ncbi.nlm.nih.gov/pubmed/28801393
http://dx.doi.org/10.1136/bmjopen-2016-014851
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