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

Study Overview
=================
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.

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.

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

Conditions
-----------------
Hypertension, Diabetes, Depression, Alcohol Use Disorder

Intervention / Treatment
-----------------
* Other: mWELLCARE
* Other: Usual Care


Participation Criteria
=================
Eligibility Criteria
-----------------
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: 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.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mWELLCARE software arm<br>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<br>* 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.<br>* Other names: Software application loaded on a tablet computer;|
| Active Comparator: Usual care arm<br>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<br>* Usual care at the community health centers<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression | Proportion of patients with moderate and severe depression measured using PHQ-9 score | Baseline and 12 months | 
| Smoking | proportion of smokers | Baseline and 12 months | 
| Body Mass Index (BMI) | Difference in BMI | Baseline and 12 months | 
| Alcohol use | Change in alcohol use to be measured using WHO- AUDIT questionnaire | Baseline and 12 months | 
| Fasting blood sugar | Difference in mean change in fasting blood sugar | Baseline and 12 months | 
| Total cholesterol | Difference in mean change in total cholesterol | Baseline and 12 months | 
| CVD risk | Difference in mean change in predicted 10 year risk of cardiovascular disease using re-caliberated Framingham Risk Score | Baseline and 12 months | 
| Cost | Costs associated with delivering intervention compared to usual care | Baseline and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Decision Support System, mHealth, Primary Health Care, Non-communicable diseases