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

NCT02480062 | Completed DMC

• 1 other identifier: mWELLCARE 107/11
• Study Type: interventional
• Target: 3,702
• Locations: 1 country
• Sites: 40

Brief 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. 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.

Conditions

Hypertension; Diabetes; Depression; Alcohol Use Disorder

Keywords

Decision Support System; mHealth; Primary Health Care; Non-communicable diseases

Outcome Measures

Primary Outcomes (2)

• Systolic blood Pressure

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

  Baseline and 12 months

• Glycated haemoglobin (HbA1c)

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

  Baseline and 12 months

Secondary Outcomes (8)

• Depression

  Baseline and 12 months

• Smoking

  Baseline and 12 months

• Body Mass Index (BMI)

  Baseline and 12 months

• Alcohol use

  Baseline and 12 months

• Fasting blood sugar

  Baseline and 12 months

Study Arms (2)

mWELLCARE software arm

EXPERIMENTAL

The 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.

Other: mWELLCARE

Usual care arm

ACTIVE COMPARATOR

In 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.

Other: Usual Care

Interventions

mWELLCARE OTHER

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.

Also known as: Software application loaded on a tablet computer

mWELLCARE software arm

Usual Care OTHER

Usual care at the community health centers

Usual care arm

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Public Health Foundation of India: lead
• Wellcome Trust: collaborator
• London School of Hygiene and Tropical Medicine: collaborator

Study Sites (40)

CHC Assandh

Āsandh, Haryana, 132039, India

Location

CHC Ballah

Ballah, Haryana, 132040, India

Location

CHC Brara

Brara, Haryana, 133201, India

Location

CHC Chauramastpur

Chauramastpur, Haryana, 134003, India

Location

CHC Gharaunda

Gharaunda, Haryana, 132114, India

Location

CHC Indri

Indri, Haryana, 132041, India

Location

CHC Jhansa

Jhānsa, Haryana, 136130, India

Location

CHC Ladwa

Lādwa, Haryana, 136132, India

Location

CHC Mathana

Mathāna, Haryana, 136131, India

Location

CHC Mullana

Mullana, Haryana, 133207, India

Location

CHC Mustafabad

Mustafābād, Haryana, 133103, India

Location

CHC Naharpur

Nāharpur, Haryana, 135001, India

Location

CHC Nilokheri

Nīlokheri, Haryana, 132116, India

Location

CHC Nissing

Nīsang, Haryana, 132024, India

Location

CHC Pehowa

Pehowa, Haryana, 136128, India

Location

CHC Radaur

Radaur, Haryana, India

Location

CHC Sadhaura

Sādhaura, Haryana, 133204, India

Location

CHC Shahzadpur

Shahzādpur, Haryana, 134202, India

Location

CHC Shahbad

Shāhābād, Haryana, 136135, India

Location

CHC Taraori

Tirāwari, Haryana, 132116, India

Location

CHC Anandapuram

Anantapur, Karnataka, 577412, India

Location

CHC Aynur

Aynur, Karnataka, 577221, India

Location

CHC Anavatti

Ānavatti, Karnataka, 577413, India

Location

Taluk Hospital Bhadravathi

Bhadravathi, Karnataka, 577301, India

Location

CHC CN Halli

CN Halli, Karnataka, 572214, India

Location

CHC Gubbi

Gubbi, Karnataka, 572216, India

Location

CHC Holehonnuru

Holehonnuru, Karnataka, 577227, India

Location

Taluk Hospital Hosanagara

Hosanagara, Karnataka, 577418, India

Location

CHC Kannangi

Kannangi, Karnataka, 577226, India

Location

General Hospital Koratagere

Koratagere, Karnataka, 572129, India

Location

General Hospital Kunigal

Kunigal, Karnataka, 572130, India

Location

CHC M.N.Kote

M.N.Kote, Karnataka, 572222, India

Location

General Hospital Madhugiri

Madhugiri, Karnataka, 572132, India

Location

General Hospital Pavagada

Pāvugada, Karnataka, 561202, India

Location

Taluk Hospital Sagar

Sāgar, Karnataka, 577401, India

Location

CHC Shiralkoppa

Shiralkoppa, Karnataka, 577428, India

Location

General Hospital Sira

Sīra, Karnataka, 572137, India

Location

CHC Kannangi

Thirthahalli, Karnataka, 577432, India

Location

General Hospital Tiptur

Tiptūr, Karnataka, 572201, India

Location

CHC Turuvekere

Turuvekere, Karnataka, 572227, India

Location

Related Publications (7)

• 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.

  PMID: 19382860 BACKGROUND

• 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.

  PMID: 18212285 BACKGROUND

• 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.

  PMID: 20639295 BACKGROUND

• 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.

  PMID: 17597964 BACKGROUND

• 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.

  PMID: 30586732 DERIVED

• 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.

  PMID: 30253691 DERIVED

• 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.

  PMID: 28801393 DERIVED

Related Links

• Curioso, W., New technologies and public health in developing countries: the Cell PREVEN project, in The Internet and health care: theory, research and practice, M. Murero and R. Rice, Editors. 2006, Lawrence Erlbaum Associates: Mahwah (NJ).
• Curioso, W. and P. Mechael, Enhancing 'M-Health' With South-To-South Collaborations. Health Affairs, 2010(29): p. 264-267.
• Vital Wave Consulting, mHealth for Development: The Opportunity of Mobile Technology for Healthcare in the Developing World. . 2009, UN Foundation-Vodafone Foundation Partnership: Washington, D.C. and Berkshire, UK.
• Hanson, K., et al., Expanding access to priority health interventions: a framework for understanding the constraints to scaling-up. J of International Development, 2003. 15(1): p. 1-14.
• Kaplan, W., Can the ubiquitous power of mobile phones be used to improve health outcomes in developing countries? . Global Health, 2006(2): p. 9.
• Rigby, M., Impact of telemedicine must be defined in developing countries. bmj, 2002. 324(7328): p. 47.
• Prince M, Patel V, Saxena S, Maj M, Maselko J, Phillips MR, et al. No health without mental health. Lancet. 2007; 370:859-77
• http://www.whoindia.org/LinkFiles/NMH\_Resources\_CVD\_RISK\_MANAGEMENT\_BOOKLET.pdf
• mhGAP Intervention Guide for mental, neurological and substance use disorders in non-specialist health settings. ver 1.0. World Health Organisation Geneva, 2010.
• Free C, Phillips G, Watson L, Gallo L, Lambert F, Patel V, Edwards P. The Effectiveness Of Mobile Health Technologies for Improving Health and Health Services: A Systematic Review. Report for Department of Health, England (in preparation)

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus; Depression; Alcoholism; Noncommunicable Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavioral Symptoms; Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dorairaj Prabhakaran

  Public Health Foundation of India

  PRINCIPAL INVESTIGATOR

• Vikram Patel

  London School of Hygeine and Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2015
• First Posted: June 24, 2015
• Study Start: April 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: October 2, 2017

Record last verified: 2017-09

Locations

IN (40)