mWELLCARE:An Integrated mHealth System for the Prevention and Care of Chronic Disease
- Conditions
- HypertensionDepressionDiabetesAlcohol Use Disorder
- Registration Number
- NCT02480062
- Lead Sponsor
- Public Health Foundation of India
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3702
- Adults aged 30 yrs+ diagnosed with hypertension and /or diabetes who are able to give written consent (or verbal witnessed consent for illiterate patients).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Glycated haemoglobin (HbA1c) Baseline and 12 months Difference in mean change in glycated haemoglobin(HbA1c) between the two treatment arms
Systolic blood Pressure Baseline and 12 months Difference in mean change in systolic blood pressure between the two treatment arms
- Secondary Outcome Measures
Name Time Method Depression Baseline and 12 months Proportion of patients with moderate and severe depression measured using PHQ-9 score
Total cholesterol Baseline and 12 months Difference in mean change in total cholesterol
Body Mass Index (BMI) Baseline and 12 months Difference in BMI
Cost Baseline and 12 months Costs associated with delivering intervention compared to usual care
Smoking Baseline and 12 months proportion of smokers
Fasting blood sugar Baseline and 12 months Difference in mean change in fasting blood sugar
CVD risk Baseline and 12 months Difference in mean change in predicted 10 year risk of cardiovascular disease using re-caliberated Framingham Risk Score
Alcohol use Baseline and 12 months Change in alcohol use to be measured using WHO- AUDIT questionnaire
Trial Locations
- Locations (39)
CHC Assandh
🇮🇳Assandh, 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
🇮🇳Jhansa, Haryana, India
CHC Ladwa
🇮🇳Ladwa, Haryana, India
CHC Mathana
🇮🇳Mathana, Haryana, India
CHC Mullana
🇮🇳Mullana, Haryana, India
Scroll for more (29 remaining)CHC Assandh🇮🇳Assandh, Haryana, India