Cargando…
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...
Autores principales: | , , , , , , , , , , , , , , |
---|---|
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 |
_version_ | 1783285299532529664 |
---|---|
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). |
format | Online Article Text |
id | pubmed-5724108 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
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 |
work_keys_str_mv | AT jhadilip protocolforthemwellcaretrialamulticentreclusterrandomised12monthcontrolledtrialtocomparetheeffectivenessofmwellcareanmhealthsystemforanintegratedmanagementofpatientswithhypertensionanddiabetesversusenhancedusualcareinindia AT guptapriti protocolforthemwellcaretrialamulticentreclusterrandomised12monthcontrolledtrialtocomparetheeffectivenessofmwellcareanmhealthsystemforanintegratedmanagementofpatientswithhypertensionanddiabetesversusenhancedusualcareinindia AT ajayvamadevans protocolforthemwellcaretrialamulticentreclusterrandomised12monthcontrolledtrialtocomparetheeffectivenessofmwellcareanmhealthsystemforanintegratedmanagementofpatientswithhypertensionanddiabetesversusenhancedusualcareinindia AT jindaldevraj protocolforthemwellcaretrialamulticentreclusterrandomised12monthcontrolledtrialtocomparetheeffectivenessofmwellcareanmhealthsystemforanintegratedmanagementofpatientswithhypertensionanddiabetesversusenhancedusualcareinindia AT perelpablo protocolforthemwellcaretrialamulticentreclusterrandomised12monthcontrolledtrialtocomparetheeffectivenessofmwellcareanmhealthsystemforanintegratedmanagementofpatientswithhypertensionanddiabetesversusenhancedusualcareinindia AT prietomerinodavid protocolforthemwellcaretrialamulticentreclusterrandomised12monthcontrolledtrialtocomparetheeffectivenessofmwellcareanmhealthsystemforanintegratedmanagementofpatientswithhypertensionanddiabetesversusenhancedusualcareinindia AT jacobpramod protocolforthemwellcaretrialamulticentreclusterrandomised12monthcontrolledtrialtocomparetheeffectivenessofmwellcareanmhealthsystemforanintegratedmanagementofpatientswithhypertensionanddiabetesversusenhancedusualcareinindia AT nyongjonathan protocolforthemwellcaretrialamulticentreclusterrandomised12monthcontrolledtrialtocomparetheeffectivenessofmwellcareanmhealthsystemforanintegratedmanagementofpatientswithhypertensionanddiabetesversusenhancedusualcareinindia AT venugopalvidya protocolforthemwellcaretrialamulticentreclusterrandomised12monthcontrolledtrialtocomparetheeffectivenessofmwellcareanmhealthsystemforanintegratedmanagementofpatientswithhypertensionanddiabetesversusenhancedusualcareinindia AT singhkavita protocolforthemwellcaretrialamulticentreclusterrandomised12monthcontrolledtrialtocomparetheeffectivenessofmwellcareanmhealthsystemforanintegratedmanagementofpatientswithhypertensionanddiabetesversusenhancedusualcareinindia AT goenkashifalika protocolforthemwellcaretrialamulticentreclusterrandomised12monthcontrolledtrialtocomparetheeffectivenessofmwellcareanmhealthsystemforanintegratedmanagementofpatientswithhypertensionanddiabetesversusenhancedusualcareinindia AT royambuj protocolforthemwellcaretrialamulticentreclusterrandomised12monthcontrolledtrialtocomparetheeffectivenessofmwellcareanmhealthsystemforanintegratedmanagementofpatientswithhypertensionanddiabetesversusenhancedusualcareinindia AT tandonnikhil protocolforthemwellcaretrialamulticentreclusterrandomised12monthcontrolledtrialtocomparetheeffectivenessofmwellcareanmhealthsystemforanintegratedmanagementofpatientswithhypertensionanddiabetesversusenhancedusualcareinindia AT patelvikram protocolforthemwellcaretrialamulticentreclusterrandomised12monthcontrolledtrialtocomparetheeffectivenessofmwellcareanmhealthsystemforanintegratedmanagementofpatientswithhypertensionanddiabetesversusenhancedusualcareinindia AT prabhakarandorairaj protocolforthemwellcaretrialamulticentreclusterrandomised12monthcontrolledtrialtocomparetheeffectivenessofmwellcareanmhealthsystemforanintegratedmanagementofpatientswithhypertensionanddiabetesversusenhancedusualcareinindia |