mWELLCARE:An Integrated mHealth System for the Prevention and Care of Chronic Disease
NCT ID: NCT02480062
Last Updated: 2017-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
3702 participants
INTERVENTIONAL
2016-04-30
2017-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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mWELLCARE software arm
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.
mWELLCARE
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 care arm
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.
Usual Care
Usual care at the community health centers
Interventions
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mWELLCARE
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 Care
Usual care at the community health centers
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Patients with learning difficulties or vision/ hearing impairments but without a care giver making it impossible to use mobile phone.
3. Pregnant and lactating women.
30 Years
ALL
No
Sponsors
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Wellcome Trust
OTHER
London School of Hygiene and Tropical Medicine
OTHER
Public Health Foundation of India
OTHER
Responsible Party
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Principal Investigators
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Dorairaj Prabhakaran
Role: PRINCIPAL_INVESTIGATOR
Public Health Foundation of India
Vikram Patel
Role: PRINCIPAL_INVESTIGATOR
London School of Hygeine and Tropical Medicine
Locations
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CHC Assandh
Āsandh, Haryana, India
CHC Ballah
Ballah, Haryana, India
CHC Brara
Brara, Haryana, India
CHC Chauramastpur
Chauramastpur, Haryana, India
CHC Gharaunda
Gharaunda, Haryana, India
CHC Indri
Indri, Haryana, India
CHC Jhansa
Jhānsa, Haryana, India
CHC Ladwa
Lādwa, Haryana, India
CHC Mathana
Mathāna, Haryana, India
CHC Mullana
Mullana, Haryana, India
CHC Mustafabad
Mustafābād, Haryana, India
CHC Naharpur
Nāharpur, Haryana, India
CHC Nilokheri
Nīlokheri, Haryana, India
CHC Nissing
Nīsang, Haryana, India
CHC Pehowa
Pehowa, Haryana, India
CHC Radaur
Radaur, Haryana, India
CHC Sadhaura
Sādhaura, Haryana, India
CHC Shahzadpur
Shahzādpur, Haryana, India
CHC Shahbad
Shāhābād, Haryana, India
CHC Taraori
Tirāwari, Haryana, India
CHC Anandapuram
Anantapur, Karnataka, India
CHC Aynur
Aynur, Karnataka, India
CHC Anavatti
Ānavatti, Karnataka, India
Taluk Hospital Bhadravathi
Bhadravathi, Karnataka, India
CHC CN Halli
CN Halli, Karnataka, India
CHC Gubbi
Gubbi, Karnataka, India
CHC Holehonnuru
Holehonnuru, Karnataka, India
Taluk Hospital Hosanagara
Hosanagara, Karnataka, India
CHC Kannangi
Kannangi, Karnataka, India
General Hospital Koratagere
Koratagere, Karnataka, India
General Hospital Kunigal
Kunigal, Karnataka, India
CHC M.N.Kote
M.N.Kote, Karnataka, India
General Hospital Madhugiri
Madhugiri, Karnataka, India
General Hospital Pavagada
Pāvugada, Karnataka, India
Taluk Hospital Sagar
Sāgar, Karnataka, India
CHC Shiralkoppa
Shiralkoppa, Karnataka, India
General Hospital Sira
Sīra, Karnataka, India
CHC Kannangi
Thirthahalli, Karnataka, India
General Hospital Tiptur
Tiptūr, Karnataka, India
CHC Turuvekere
Turuvekere, Karnataka, India
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Related Links
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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.
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)
Other Identifiers
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mWELLCARE 107/11
Identifier Type: -
Identifier Source: org_study_id