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HypertensionmWELLCARENCT02480062

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

A study testing mWELLCARE in people with Hypertension and Diabetes, run by Public Health Foundation of India at 40 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Hypertension, Diabetes, Depression
What is being tested?
mWELLCARE
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,702 participants
Where
40 sitesIndia
Study dates
Apr 2016to Sep 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults aged 30 yrs+ diagnosed with hypertension and /or diabetes who are able to give written consent (or verbal witnessed consent for illiterate patients).

Who cannot join

  • Patient requiring immediate referral to tertiary care due to accelerated hypertension, diabetic complications.
  • Patients with learning difficulties or vision/ hearing impairments but without a care giver making it impossible to use mobile phone.
  • Pregnant and lactating women.

Trial locations and contacts

40 sites in 1 country.

40 sites in 1 country

India40 sites

  • CHC Anandapuram

    Anantapur, Karnataka, 577412

  • CHC Anavatti

    Ānavatti, Karnataka, 577413

  • CHC Assandh

    Āsandh, Haryana, 132039

  • CHC Aynur

    Aynur, Karnataka, 577221

  • CHC Ballah

    Ballah, Haryana, 132040

  • Taluk Hospital Bhadravathi

    Bhadravathi, Karnataka, 577301

  • CHC Brara

    Brara, Haryana, 133201

  • CHC Chauramastpur

    Chauramastpur, Haryana, 134003

  • CHC CN Halli

    CN Halli, Karnataka, 572214

  • CHC Gharaunda

    Gharaunda, Haryana, 132114

  • CHC Gubbi

    Gubbi, Karnataka, 572216

  • CHC Holehonnuru

    Holehonnuru, Karnataka, 577227

  • Taluk Hospital Hosanagara

    Hosanagara, Karnataka, 577418

  • CHC Indri

    Indri, Haryana, 132041

  • CHC Jhansa

    Jhānsa, Haryana, 136130

  • CHC Kannangi

    Kannangi, Karnataka, 577226

  • General Hospital Koratagere

    Koratagere, Karnataka, 572129

  • General Hospital Kunigal

    Kunigal, Karnataka, 572130

  • CHC Ladwa

    Lādwa, Haryana, 136132

  • CHC M.N.Kote

    M.N.Kote, Karnataka, 572222

  • General Hospital Madhugiri

    Madhugiri, Karnataka, 572132

  • CHC Mathana

    Mathāna, Haryana, 136131

  • CHC Mullana

    Mullana, Haryana, 133207

  • CHC Mustafabad

    Mustafābād, Haryana, 133103

  • CHC Naharpur

    Nāharpur, Haryana, 135001

  • CHC Nilokheri

    Nīlokheri, Haryana, 132116

  • CHC Nissing

    Nīsang, Haryana, 132024

  • General Hospital Pavagada

    Pāvugada, Karnataka, 561202

  • CHC Pehowa

    Pehowa, Haryana, 136128

  • CHC Radaur

    Radaur, Haryana

  • CHC Sadhaura

    Sādhaura, Haryana, 133204

  • Taluk Hospital Sagar

    Sāgar, Karnataka, 577401

  • CHC Shahbad

    Shāhābād, Haryana, 136135

  • CHC Shahzadpur

    Shahzādpur, Haryana, 134202

  • CHC Shiralkoppa

    Shiralkoppa, Karnataka, 577428

  • General Hospital Sira

    Sīra, Karnataka, 572137

  • CHC Kannangi

    Thirthahalli, Karnataka, 577432

  • General Hospital Tiptur

    Tiptūr, Karnataka, 572201

  • CHC Taraori

    Tirāwari, Haryana, 132116

  • CHC Turuvekere

    Turuvekere, Karnataka, 572227

Other trials in India

About this study

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.

Read the detailed description

Cardiovascular disease (CVD) and diabetes are the leading causes of premature (<60 years) adult deaths in India with projections indicating an almost 3-fold increase to 18 million premature years of life lost by 2030. CVD and diabetes will result in $336.6 billion in lost national income in India over the next decade. The major barriers to the control of these conditions in India are the low detection rates early in the course of the condition, inadequate use of evidence based interventions and low adherence with these interventions. After detection of these conditions, the long-term health outcomes of persons affected is heavily dependent on adherence with care guidelines and is a major priority.

Harnessing the potential of Smartphone technology would be a solution for addressing these challenges at the community level by improving the quality of care. There are several advantages for Smartphone technology that makes it an ideal tool for improving the quality care at the government facilities. Smartphones/tablet computers are low-cost, requires less investment in infrastructure and are ubiquitous used by the masses.

Primary health care settings are best suited to address the prevention and management of hypertension/diabetes and its risk factors. Given these reasons, the Government of India, is planning to scale-up the National Program on prevention and control of cancer, diabetes, cardiovascular diseases and stroke (NPCDCS) giving a major thrust to screening, diagnosis and management of hypertension and diabetes at community level by starting NCD clinics at the Community Health Centres and assigning new roles to the Health Workers at the sub-centers.

In the above context, the investigators plan to develop a tablet computer application for the Medical Officers and Nurse enabling them to deliver high quality care at Community Health Centres (CHCs). The tablet computer application will be capable of running clinical risk scores for identifying people at high risk of diabetes, cardiovascular disease, and computing personalized management plan using evidence-based clinical management guidelines. The feasibility and effectiveness of such a novel application is to be formally evaluated in order to develop a robust clinical decision support system for the Nurses and Medical Officers at the public health facilities.

In brief, the investigators plan to implement the research project in the 20 CHCs each in 2 states in India i.e.Haryana and Karnataka. Out of these, 10 CHCs will receive the mWellcare interventions. In the intervention arm, the NPCDCS Nurses will register 30 years+ patient diagnosed with hypertension and diabetes using tablet computer based Decision Support Software (DSS). For the patients identified with hypertension/diabetes or at high risk, the software will provide individual tailored management plan that would include treatment plan, lifestyle advice and follow up schedule. Thus, Medical Officers at CHCs will be able to prescribe a guideline based management plan for these patients with the help of DSS. The software will store relevant health parameters of patients at local database (tablet computer) and central server that could be accessed during the follow-up visits of the patients or whenever required.

To make meaningful comparison on the impact of the new technology enabled services in improving the quality of care of diabetes and hypertension at the CHCs, the investigators will collect data from 10 more CHCs that provide routine/usual care to the patients. A structured training will be conducted for Medical Officers and Nurse at CHCs (both from the intervention \& usual care arm) on evidence based management of hypertension and diabetes prior to the start of the project.

The intervention will be carried out for a period of 1 year that would include regular follow up. The effect of the intervention will be assessed at six and twelve month comparing the blood pressure and blood glucose values of the patients in two groups.

This project has considerable importance because of the fact that the utility of tablet computer based clinical decision support systems in the management of hypertension and diabetes at the public health facilities has not been evaluated in developing countries so far. If found successful, the technology has the potential to be upscale not only in Haryana and Karnataka but across the country in government and private healthcare settings.

Being tested
mWELLCARE, Usual Care
Keywords
Decision Support System, mHealth, Primary Health Care, Non-communicable diseases
Medical subject headings
Hypertension, Diabetes Mellitus, Depression, Alcoholism, Noncommunicable Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mWELLCAREOther

    Also called Software application loaded on a tablet computer

    mWELLCARE intervention arm will include a software application loaded on a tablet computer that will be used by Nurse Care Coordinators (posted in community health centers) in the course of their jobs to register patients with hypertension or diabetes, to generate clinical decision support recommendations, to track these patients over time and to improve follow-up care. Decision support recommendations will be printed and given to a doctor, who will make the final call on the management plan that will be used for the patient. Registered patients will also receive customized messages on their mobile phone. In addition, at sites where network connectivity permits, the doctor may also be equipped with a doctor's app on a tablet that will be largely the same as the NCC app.

  • Usual CareOther

    Usual care at the community health centers

Study groups in NCT02480062
Study groupRoleWhat they receive
mWELLCARE software armExperimentalThe doctor and nurse care coordinators (NCCs) in the mWELLCARE intervention arm will be trained on the use of mWELLCARE software loaded on a tablet computer. Patients diagnosed with hypertension and/or diabetes will be registered by the nurse using mWellcare application. The nurse will record patient parameters, medical history, medication etc and generate a management plan (including drug recommendation, lifestyle advise) using the mWellcare application based on standard treatment guidelines. The doctor will review the recommendation and agree or disagree giving reasons. Patient will be followed up using SMS.
Receives: Other: mWELLCARE
Usual care armActive comparatorIn the control arm or the usual care arm CHCs, the doctor and Nurse will get "refresher" training in the detection, management and follow up of hypertension and diabetes patients based on standard guidelines. They will be provided with charts for quick reference to standard treatment guidelines. Patients diagnosed with hypertension and/or diabetes will be managed by the doctor at the CHC. The nurse will assist in recording blood pressure, height, weight etc, providing lifestyle advise and follow up advice to patients.
Receives: Other: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Systolic blood Pressure

    Difference in mean change in systolic blood pressure between the two treatment arms

    Measured: Baseline and 12 months

  2. Glycated haemoglobin (HbA1c)

    Difference in mean change in glycated haemoglobin(HbA1c) between the two treatment arms

    Measured: Baseline and 12 months

Secondary outcomes (8)

  1. Depression

    Proportion of patients with moderate and severe depression measured using PHQ-9 score

    Measured: Baseline and 12 months

  2. Smoking

    proportion of smokers

    Measured: Baseline and 12 months

  3. Body Mass Index (BMI)

    Difference in BMI

    Measured: Baseline and 12 months

  4. Alcohol use

    Change in alcohol use to be measured using WHO- AUDIT questionnaire

    Measured: Baseline and 12 months

  5. Fasting blood sugar

    Difference in mean change in fasting blood sugar

    Measured: Baseline and 12 months

  6. Total cholesterol

    Difference in mean change in total cholesterol

    Measured: Baseline and 12 months

  7. CVD risk

    Difference in mean change in predicted 10 year risk of cardiovascular disease using re-caliberated Framingham Risk Score

    Measured: Baseline and 12 months

  8. Cost

    Costs associated with delivering intervention compared to usual care

    Measured: Baseline and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2015 (estimated)
  2. Study startApr 2016
  3. Primary completionSep 2017
  4. Study completionSep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3,702 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02480062
Sponsor's protocol ID
mWELLCARE 107/11
Acronym
mWELLCARE
Status last verified
Sep 2017
First submitted
26 May 2015
Last updated
2 Oct 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Krishna S, Boren SA, Balas EA. Healthcare via cell phones: a systematic review. Telemed J E Health. 2009 Apr;15(3):231-40. doi: 10.1089/tmj.2008.0099.

    PubMed 19382860

  • D'Agostino RB Sr, Vasan RS, Pencina MJ, Wolf PA, Cobain M, Massaro JM, Kannel WB. General cardiovascular risk profile for use in primary care: the Framingham Heart Study. Circulation. 2008 Feb 12;117(6):743-53. doi: 10.1161/CIRCULATIONAHA.107.699579. Epub 2008 Jan 22.

    PubMed 18212285

  • Chalkidou K, Levine R, Dillon A. Helping poorer countries make locally informed health decisions. BMJ. 2010 Jul 16;341:c3651. doi: 10.1136/bmj.c3651. No abstract available.

    PubMed 20639295

  • Wee HL, Loke WC, Li SC, Fong KY, Cheung YB, Machin D, Luo N, Thumboo J. Cross-cultural adaptation and validation of Singapore Malay and Tamil versions of the EQ-5D. Ann Acad Med Singap. 2007 Jun;36(6):403-8.

    PubMed 17597964

  • Prabhakaran D, Jha D, Prieto-Merino D, Roy A, Singh K, Ajay VS, Jindal D, Gupta P, Kondal D, Goenka S, Jacob P, Singh R, Kumar BGP, Perel P, Tandon N, Patel V; Members of the Research Steering Committee,Investigators,Members of the Data Safety and Monitoring Board. Effectiveness of an mHealth-Based Electronic Decision Support System for Integrated Management of Chronic Conditions in Primary Care: The mWellcare Cluster-Randomized Controlled Trial. Circulation. 2019 Jan 15;139(3):380-391. doi: 10.1161/CIRCULATIONAHA.118.038192. Epub 2018 Nov 10.

    PubMed 30586732

  • Jindal D, Gupta P, Jha D, Ajay VS, Goenka S, Jacob P, Mehrotra K, Perel P, Nyong J, Roy A, Tandon N, Prabhakaran D, Patel V. Development of mWellcare: an mHealth intervention for integrated management of hypertension and diabetes in low-resource settings. Glob Health Action. 2018;11(1):1517930. doi: 10.1080/16549716.2018.1517930.

    PubMed 30253691

  • Jha D, Gupta P, Ajay VS, Jindal D, Perel P, Prieto-Merino D, Jacob P, Nyong J, Venugopal V, Singh K, Goenka S, Roy A, Tandon N, Patel V, Prabhakaran D. 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. BMJ Open. 2017 Aug 11;7(8):e014851. doi: 10.1136/bmjopen-2016-014851.

    PubMed 28801393

Questions about this trial

What is this clinical trial studying?

A study testing mWELLCARE in people with Hypertension and Diabetes, run by Public Health Foundation of India at 40 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Systolic blood Pressure (time frame: Baseline and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02480062, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2017.

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