Clinical trial NCT02480062: mWELLCARE:An Integrated mHealth System for the Prevention and Care of Chronic Disease
Official title: mWELLCARE:An Integrated mHealth System for the Prevention and Care of Chronic Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Diabetes
Depression
Alcohol Use Disorder
Keywords: Decision Support System
mHealth
Primary Health Care
Non-communicable diseases
Lead sponsor: Public Health Foundation of India
Sponsor class: OTHER
Collaborators: name: Wellcome Trust
name: London School of Hygiene and Tropical Medicine
First posted: 2015-06-24
Enrollment: 3702
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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:

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.

Primary outcomes:
measure: Systolic blood Pressure
timeFrame: Baseline and 12 months
measure: Glycated haemoglobin (HbA1c)
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Depression
timeFrame: Baseline and 12 months
measure: Smoking
timeFrame: Baseline and 12 months
measure: Body Mass Index (BMI)
timeFrame: Baseline and 12 months
measure: Alcohol use
timeFrame: Baseline and 12 months
measure: Fasting blood sugar
timeFrame: Baseline and 12 months
measure: Total cholesterol
timeFrame: Baseline and 12 months
measure: CVD risk
timeFrame: Baseline and 12 months
measure: Cost
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Assandh
country: India
facility: CHC Assandh
state: Haryana
city: Ballah
country: India
facility: CHC Ballah
state: Haryana
city: Brara
country: India
facility: CHC Brara
state: Haryana
city: Chauramastpur
country: India
facility: CHC Chauramastpur
state: Haryana
city: Gharaunda
country: India
facility: CHC Gharaunda
state: Haryana
city: Indri
country: India
facility: CHC Indri
state: Haryana
city: Jhansa
country: India
facility: CHC Jhansa
state: Haryana
city: Ladwa
country: India
facility: CHC Ladwa
state: Haryana
city: Mathana
country: India
facility: CHC Mathana
state: Haryana
city: Mullana
country: India
facility: CHC Mullana
state: Haryana
city: Mustafabad
country: India
facility: CHC Mustafabad
state: Haryana
city: Naharpur
country: India
facility: CHC Naharpur
state: Haryana
city: Nilokheri
country: India
facility: CHC Nilokheri
state: Haryana
city: Nissing
country: India
facility: CHC Nissing
state: Haryana
city: Pehowa
country: India
facility: CHC Pehowa
state: Haryana
city: Radaur
country: India
facility: CHC Radaur
state: Haryana
city: Sadhaura
country: India
facility: CHC Sadhaura
state: Haryana
city: Shahbad
country: India
facility: CHC Shahbad
state: Haryana
city: Shahzadpur
country: India
facility: CHC Shahzadpur
state: Haryana
city: Taraori
country: India
facility: CHC Taraori
state: Haryana
city: Anandapuram
country: India
facility: CHC Anandapuram
state: Karnataka
city: Anavatti
country: India
facility: CHC Anavatti
state: Karnataka
city: Aynur
country: India
facility: CHC Aynur
state: Karnataka
city: Bhadravathi
country: India
facility: Taluk Hospital Bhadravathi
state: Karnataka
city: CN Halli
country: India
facility: CHC CN Halli
state: Karnataka
city: Gubbi
country: India
facility: CHC Gubbi
state: Karnataka
city: Holehonnuru
country: India
facility: CHC Holehonnuru
state: Karnataka
city: Hosanagara
country: India
facility: Taluk Hospital Hosanagara
state: Karnataka
city: Kannangi
country: India
facility: CHC Kannangi
state: Karnataka
city: Koratagere
country: India
facility: General Hospital Koratagere
state: Karnataka
city: Kunigal
country: India
facility: General Hospital Kunigal
state: Karnataka
city: M.N.Kote
country: India
facility: CHC M.N.Kote
state: Karnataka
city: Madhugiri
country: India
facility: General Hospital Madhugiri
state: Karnataka
city: Pavagada
country: India
facility: General Hospital Pavagada
state: Karnataka
city: Sagar
country: India
facility: Taluk Hospital Sagar
state: Karnataka
city: Shiralkoppa
country: India
facility: CHC Shiralkoppa
state: Karnataka
city: Sira
country: India
facility: General Hospital Sira
state: Karnataka
city: Thirthahalli
country: India
facility: CHC Kannangi
state: Karnataka
city: Tiptur
country: India
facility: General Hospital Tiptur
state: Karnataka
city: Turuvekere
country: India
facility: CHC Turuvekere
state: Karnataka
Study officials:
affiliation: Public Health Foundation of India
name: Dorairaj Prabhakaran
role: PRINCIPAL_INVESTIGATOR
affiliation: London School of Hygeine and Tropical Medicine
name: Vikram Patel
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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 Singap. 2007 Jun;36(6):403-8.
citation: 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.
citation: 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.
citation: 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.