Innovative Mhealth led Participatory Approach to Comprehensive Screening and Treatment of Diabetes (IMPACT-Diabetes)
Diabetes mellitus is one of the most important causes of death and disability contributing to a significant proportion of healthcare expenditure in India. Primary health centres (PHCs) are the first level of contact for management of patients with Diabetes, but guidelines-based care is usually not a part of the clinical routine. The distances required to travel, uncertainty regarding the availability of the doctors and cost in terms of loss of wages, make PHCs not the preferred choice for availing health services by the community.
Aim and Objective:
Project aims to develop and pilot-test a bespoke diabetes management programme designed for implementation within existing healthcare systems in rural India. IMPACT Diabetes study proposes the development and evaluation (the feasibility, acceptability and preliminary effectiveness) of a novel diabetes management program that utilizes the existing non-physician healthcare workers and uses technology (clinical decision support system (CDSS)) for early detection of diabetes, management and prevention of its complications in individuals aged ≥30 years with diabetes. Specific objectives are:
1. To develop and validate a CDSS for diabetes care.
2. To field test this system with two different approaches of care to demonstrate the feasibility, acceptability and preliminary effectiveness of these approaches through a feasibility study.
Study Duration and Design:
The entire duration of the study is fifteen months. The community based intervention will be conducted for nine months. The study proposes to follow a quasi-experimental, pre-post implementation trial design to compare the preliminary effectiveness of the two approaches of care. The qualitative component of the study will observe the delivery, acceptability and feasibility of implementing these two different approaches in community setting during the trial itself.
Study Algorithm Development and Testing:
A plain language algorithm for screening and management for diabetes will be generated based on the latest Indian guidelines. This algorithm will be further developed into a statistical and a programming code. The algorithm will further undergo an iterative testing, refinement and validation before it is deployed on a technological platform. A diabetes training programme will be developed and provided to NPHWs and primary care physicians.
This study will be conducted in two sites including the West Godavari District of Andhra Pradesh and Rohtak district of Haryana. A total of 8 PHCs will be selected across both the study sites. Within each PHC, 2 villages -one big (~6000 population) and other small (~3000 population) will be randomly selected from all the villages being served by the PHCs. Within each village, one Accredited Social Health Activist (ASHA) – frontline health worker in the community will be randomly selected.
George Institute India, University College of Medical Sciences, Delhi
Regulatory approvals obtained, Trial related training at the sites
An evaluation of the study will be conducted using both quantitative and qualitative components. For the quantitative outcome an independent team will be responsible for conducting an end of the study evaluation. A set of 3 tests namely capillary RBS, capillary FBG and HBA1c will be performed on the people who were found to have an elevated blood sugar level in their initial screening (both capillary RBS and capillary FBG). This testing will be performed on individuals from both the approaches of care and the results of this testing will be used to compare the two approaches for their preliminary effectiveness. Some of the quantitative outcomes to be measured in this study include prevalence of suspected diabetes and confirmed cases of diabetes, proportion of individuals visiting a doctor and adherence to medication. The qualitative outcomes of the study will assess the acceptability, implementation feasibility and preliminary effectiveness of the intervention. In addition, detailed process indicators will also be collected and analysed.