NCT02480062: mWELLCARE

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

Completed NA Last updated 28 September 2017

What this trial tests

NA trial testing mWELLCARE in Hypertension in 3,702 participants. Completed in 1 September 2017.

Timeline

1 April 2016

Primary endpoint
1 September 2017

1 September 2017

Quick facts

Lead sponsor	Public Health Foundation of India
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	3,702
Start date	1 April 2016
Primary completion	1 September 2017
Estimated completion	1 September 2017
Sites	40 locations across India

Drugs / interventions tested

• mWELLCARE
• Usual Care

Conditions studied

• Hypertension — all drugs for Hypertension →
• Diabetes — all drugs for Diabetes →
• Depression — all drugs for Depression →
• Alcohol Use Disorder — all drugs for Alcohol Use Disorder →

Sponsor

Public Health Foundation of India

Who can join

30 and older, any sex, with Hypertension or Diabetes. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Systolic blood Pressure
  Time frame: Baseline and 12 months
  Difference in mean change in systolic blood pressure between the two treatment arms
• Glycated haemoglobin (HbA1c)
  Time frame: Baseline and 12 months
  Difference in mean change in glycated haemoglobin(HbA1c) between the two treatment arms

Sponsor's own description

Major barriers to controlling cardiovascular diseases (CVDs) in India and elsewhere are: low detection rates, inadequate use of evidence based interventions and low adherence with these interventions. Primary health care is the appropriate setting for improving the prevention and management of these chronic conditions. The investigators will develop and evaluate an innovative mobile health (mHealth) software application -'m-WELLCARE'- which provides a patient health profile, decision support for clinical care, monitoring and feedback for use in Indian Community Health Centers (CHCs). The investigators will conduct this research following the steps proposed by the medical research council (MRC) for evaluation of complex interventions. Technical development of m-WELLCARE will be conducted, user acceptability appraised and potential barriers overcome. m-WELLCARE will be evaluated in CHCs of two states, Haryana and Karnataka. The use made of m-WELLCARE, its impact on patterns of health care received and changes in risk factors achieved will be evaluated.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Beyond the Randomized Controlled Trial: A Review of Alternatives in mHealth Clinical Trial Methods.
   Pham Q, Wiljer D, Cafazzo JA. · · 2016 · cited 113× · PMID 27613084 · DOI 10.2196/mhealth.5720
2. Effectiveness of an mHealth-Based Electronic Decision Support System for Integrated Management of Chronic Conditions in Primary Care: The mWellcare Cluster-Randomized Controlled Trial.
   Prabhakaran D, Jha D, Prieto-Merino D, Roy A, et al · · 2019 · cited 84× · PMID 30586732 · DOI 10.1161/circulationaha.118.038192
3. Mobile phone-based interventions for improving adherence to medication prescribed for the primary prevention of cardiovascular disease in adults.
   Palmer MJ, Barnard S, Perel P, Free C. · · 2018 · cited 53× · PMID 29932455 · DOI 10.1002/14651858.cd012675.pub2
4. Development of mWellcare: an mHealth intervention for integrated management of hypertension and diabetes in low-resource settings.
   Jindal D, Gupta P, Jha D, Ajay VS, et al · · 2018 · cited 37× · PMID 30253691 · DOI 10.1080/16549716.2018.1517930
5. Mobile phone-based interventions for improving adherence to medication prescribed for the primary prevention of cardiovascular disease in adults.
   Palmer MJ, Machiyama K, Woodd S, Gubijev A, et al · · 2021 · cited 25× · PMID 33769555 · DOI 10.1002/14651858.cd012675.pub3
6. 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 D, Gupta P, Ajay VS, Jindal D, et al · · 2017 · cited 20× · PMID 28801393 · DOI 10.1136/bmjopen-2016-014851
7. Primary-level and community worker interventions for the prevention of mental disorders and the promotion of well-being in low- and middle-income countries.
   Purgato M, Prina E, Ceccarelli C, Cadorin C, et al · · 2023 · cited 17× · PMID 37873968 · DOI 10.1002/14651858.cd014722.pub2
8. Digital tracking, provider decision support systems, and targeted client communication via mobile devices to improve primary health care.
   Agarwal S, Chin WY, Vasudevan L, Henschke N, et al · · 2025 · cited 9× · PMID 40193137 · DOI 10.1002/14651858.cd012925.pub2