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

Hypertension Clinical Trial

— mWELLCARE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02480062
• Other study ID #: mWELLCARE 107/11
• Status: Completed
• Phase: N/A
• First received: May 26, 2015
• Last updated: September 28, 2017
• Start date: April 2016
• Est. completion date: September 2017

Study information

• Verified date: September 2017
• Source: Public Health Foundation of India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3702
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

1. Patient requiring immediate referral to tertiary care due to accelerated hypertension, diabetic complications.

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.

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Chronic Disease
• Depression
• Diabetes
• Hypertension

Intervention

Other:
• 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

Locations

Country	Name	City	State
India	CHC Anandapuram	Anandapuram	Karnataka
India	CHC Anavatti	Anavatti	Karnataka
India	CHC Assandh	Assandh	Haryana
India	CHC Aynur	Aynur	Karnataka
India	CHC Ballah	Ballah	Haryana
India	Taluk Hospital Bhadravathi	Bhadravathi	Karnataka
India	CHC Brara	Brara	Haryana
India	CHC Chauramastpur	Chauramastpur	Haryana
India	CHC CN Halli	CN Halli	Karnataka
India	CHC Gharaunda	Gharaunda	Haryana
India	CHC Gubbi	Gubbi	Karnataka
India	CHC Holehonnuru	Holehonnuru	Karnataka
India	Taluk Hospital Hosanagara	Hosanagara	Karnataka
India	CHC Indri	Indri	Haryana
India	CHC Jhansa	Jhansa	Haryana
India	CHC Kannangi	Kannangi	Karnataka
India	General Hospital Koratagere	Koratagere	Karnataka
India	General Hospital Kunigal	Kunigal	Karnataka
India	CHC Ladwa	Ladwa	Haryana
India	CHC M.N.Kote	M.N.Kote	Karnataka
India	General Hospital Madhugiri	Madhugiri	Karnataka
India	CHC Mathana	Mathana	Haryana
India	CHC Mullana	Mullana	Haryana
India	CHC Mustafabad	Mustafabad	Haryana
India	CHC Naharpur	Naharpur	Haryana
India	CHC Nilokheri	Nilokheri	Haryana
India	CHC Nissing	Nissing	Haryana
India	General Hospital Pavagada	Pavagada	Karnataka
India	CHC Pehowa	Pehowa	Haryana
India	CHC Radaur	Radaur	Haryana
India	CHC Sadhaura	Sadhaura	Haryana
India	Taluk Hospital Sagar	Sagar	Karnataka
India	CHC Shahbad	Shahbad	Haryana
India	CHC Shahzadpur	Shahzadpur	Haryana
India	CHC Shiralkoppa	Shiralkoppa	Karnataka
India	General Hospital Sira	Sira	Karnataka
India	CHC Taraori	Taraori	Haryana
India	CHC Kannangi	Thirthahalli	Karnataka
India	General Hospital Tiptur	Tiptur	Karnataka
India	CHC Turuvekere	Turuvekere	Karnataka

Sponsors (3)

Lead Sponsor	Collaborator
Public Health Foundation of India	London School of Hygiene and Tropical Medicine, Wellcome Trust

Country where clinical trial is conducted

India, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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 Singapore. 2007 Jun;36(6):403-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic blood Pressure	Difference in mean change in systolic blood pressure between the two treatment arms	Baseline and 12 months
Primary	Glycated haemoglobin (HbA1c)	Difference in mean change in glycated haemoglobin(HbA1c) between the two treatment arms	Baseline and 12 months
Secondary	Depression	Proportion of patients with moderate and severe depression measured using PHQ-9 score	Baseline and 12 months
Secondary	Smoking	proportion of smokers	Baseline and 12 months
Secondary	Body Mass Index (BMI)	Difference in BMI	Baseline and 12 months
Secondary	Alcohol use	Change in alcohol use to be measured using WHO- AUDIT questionnaire	Baseline and 12 months
Secondary	Fasting blood sugar	Difference in mean change in fasting blood sugar	Baseline and 12 months
Secondary	Total cholesterol	Difference in mean change in total cholesterol	Baseline and 12 months
Secondary	CVD risk	Difference in mean change in predicted 10 year risk of cardiovascular disease using re-caliberated Framingham Risk Score	Baseline and 12 months
Secondary	Cost	Costs associated with delivering intervention compared to usual care	Baseline and 12 months

External Links

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•   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.
•   World Health Organization, Prevention of cardiovascular disease : guidelines for assessment and management of total cardiovascular risk. 2007: Geneva.
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