A Stepped Wedge Cluster Randomized Trial to evaluate the effectiveness of a Community leader-driven kit-based Diabetes-Self-Management-Education approach in improving diabetes control and care: A study protocol for The DElhi Diabetes INTervention Trial (DEDINTT)

Abstract

Abstract Introduction: Diabetes self-management education (DSME) helps patients self-manage their condition and improve outcomes/quality of life. However, access to DSME is limited, particularly in low-income areas. This study aims to develop a DSME training kit (EK-DIN), understand barriers to implementation and evaluate the effectiveness and sustainability of Community Leader (CL) based rollout using a stepped wedge cluster randomised trial format. Methods and Analysis: The mixed methods study will begin with a qualitative study to evaluate the facilitators and barriers towards CL-based DSME. The in-depth interview notes will be transcribed for thematic analysis. These results will be utilized for a stakeholder’s workshop to develop the EK-DIN kit, a patient-interfacing app, and an implementation plan. Roll-out will be conducted in 30 clusters in Delhi preselected by the DEDICOM-II survey in 5 steps (6 clusters every three months:2 each from each socio-economic category; randomly selected per sequence). A CL from each cluster will be trained in using the EK-DIN kit /app over one month. The trained CL will conduct DSME sessions amongst the cluster residents using the EK-DIN kits provided fortnightly for three months. Compliance and blood parameters data will be collected at baseline, three months after the intervention and every quarter thereafter till completion. Change in HbA1c before and after the intervention will be evaluated as the primary outcome using the swCRTdesign package for R version 4.0.2 and the swSummary function. The sustainability of the effects will be evaluated using the change in quarterly parameters after intervention completion. Discussion: A positive result will set the template for a generalisable public health intervention with proven community effectiveness, sustainability, cost-effectiveness and positive quality of life impact. While a negative result will require the testing of alternative approaches it would still add substantially to existing knowledge on the subject. Given the diverse socio-cultural setting in which the trial is being proposed and the high power of the study, the results (positive or negative) should be widely applicable and have policy implications. Trial Registration Number:CTRI/2023/07/054963