Evidence map›Paper›PMID 28801393›Full record

Trial reportBMJ open2017

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.

Dilip Jha, Priti Gupta, Vamadevan S Ajay, Devraj Jindal, Pablo Perel, David Prieto-Merino, Pramod Jacob, Jonathan Nyong, Vidya Venugopal, Kavita Singh and 5 more

Registry-linked trialOpen access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02480062 (mWELLCARE), which is not on this map. Cited by 15 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 5 pooled it
7.4field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02480062 nacompletednot on this map

mWELLCARE:An Integrated mHealth System for the Prevention and Care of Chronic Disease

TypeinterventionalSponsorPublic Health Foundation of IndiaRan2016 to 2017Enrolled3,702ConditionsHypertension, Diabetes, Depression, Alcohol Use DisorderArmsmWELLCARE, Usual Care
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 5 syntheses or guidelines pooled it, 28 citations in OpenAlex.

  1. Pooled it
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  6. Trial
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  14. Cardiovascular Diseases in India Compared With the United States.Journal of the American College of Cardiology · 2018
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 4 institutions in 4 countries.

Dilip JhaCentre for Control of Chronic Conditions, Public Health Foundation of India, Gurgaon, India.
Priti GuptaCentre for Control of Chronic Conditions, Public Health Foundation of India, Gurgaon, India.
Vamadevan S AjayCentre for Control of Chronic Conditions, Public Health Foundation of India, Gurgaon, India.
Devraj JindalCentre for Control of Chronic Conditions, Public Health Foundation of India, Gurgaon, India.
Pablo PerelCentre for Control of Chronic Conditions, London School of Hygiene and Tropical Medicine, London, UK.
David Prieto-MerinoCentre for Control of Chronic Conditions, London School of Hygiene and Tropical Medicine, London, UK.
Pramod JacobCentre for Control of Chronic Conditions, Public Health Foundation of India, Gurgaon, India.
Jonathan NyongCentre for Control of Chronic Conditions, London School of Hygiene and Tropical Medicine, London, UK.
Vidya VenugopalCentre for Control of Chronic Conditions, Public Health Foundation of India, Gurgaon, India.
Kavita SinghCentre for Control of Chronic Conditions, Public Health Foundation of India, Gurgaon, India.
Shifalika GoenkaCentre for Control of Chronic Conditions, Public Health Foundation of India, Gurgaon, India.
Ambuj RoyDepartment of Cardiology, Centre for Control of Chronic Conditions, All India Institute of Medical Sciences, New Delhi, India.
Nikhil TandonDepartment of Endocrinology and Metabolism, Centre for Control of Chronic Conditions, All India Institute of Medical Sciences, New Delhi, India.
Vikram PatelCentre for Control of Chronic Conditions, London School of Hygiene and Tropical Medicine, London, UK.
Dorairaj PrabhakaranCentre for Control of Chronic Conditions, Public Health Foundation of India, Gurgaon, India.
Public Health Foundation of India · INLondon School of Hygiene & Tropical Medicine · GBAll India Institute of Medical Sciences · INUniversity of Pittsburgh · US

Funding

Wellcome TrustWellcome Trust 096735/A/11/Z
6 · The paper itself

Abstract

introductionRising 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 registrationmWellcare 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).

Indexed as

Primary Health CareRural PopulationTelemedicineBlood GlucoseCardiovascular DiseasesCell PhoneCluster AnalysisCost-Benefit AnalysisDecision Support Systems, ClinicalDiabetes MellitusEvidence-Based MedicineGlycated HemoglobinGuideline AdherenceHumansHypertensionIndiaBlood GlucoseGlycated Hemoglobinhemoglobin A1c protein, humandecision support systemdiabeteshypertensionintegrated management of chronic conditionsmHealth

Identifiers

PMID28801393
PMCPMC5724108
OpenAlexW2743562460

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.