Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-25 @ 2:50 AM
NCT ID:
NCT03938233
Brief Summary:
Type 2 diabetes is amongst the foremost challenges facing policy makers in Thailand, accounting for considerable death, disability and healthcare expenditure. Under Thailand's strong primary health system, medical management of diabetes is widely available. However, control of blood glucose and other cardiovascular disease risk factors, and regular screening for early detection of complications remain low due to a lack of services for education and counselling to support behavioural changes necessary for good self-management of the condition. A substantial literature documents the effectiveness of Diabetes Self-Management Education (DSME) programs for improving diabetes outcomes, although little high-quality data are available in Thailand, and traditional delivery models (health-professional led one-to-one or small-group sessions) are unlikely to be scalable in Thailand given current human resource and budgetary constraints. Thus, a low-cost DSME program will be developed with a scalable delivery model for roll-out within the Thai primary care system. The intervention will be based on behaviour-change and social support theories, delivered in monthly group meetings by lay health workers or nurses, and aided by a suite of short films to introduce key topics and stimulate discussion. 21 primary care units will be randomised to offer to those with diabetes diagnosed within the first three years. DSME will be delivered by lay health workers, nurses (for comparative effectiveness), or usual care. After 12 months, glycaemic control and cardiovascular risk scores will be compared between the three arms. Cost-effectiveness will be assessed, also process and policy evaluations to produce best-buy recommendations for the Thai Ministry of Public Health.
Detailed Description:
The health and economic consequences of Type 2 diabetes mellitus are largely attributable to its complications, which can be prevented or delayed by good disease control, achieved through medical care and self-management. Diabetes Self- Management Education (DSME) programs are effective and cost-effective, and part of standard care in high-income countries, but are unavailable in Thai healthcare system, despite universal coverage of medical aspects of diabetes care. Negative perceptions of educational programs, sustained by a lack of high-quality local data, and concerns about burden on existing staff time and costs are thought to be responsible.
Given the focus on community-based education for chronic diseases in recent primary healthcare reforms, it is timely to scale-up DSME in Thailand, if an affordable model of delivery for a locally-tailored intervention can be found. The aim is to work in close collaboration with the Thai Ministry of Public Health to develop, pilot and evaluate a peer-based DSME program and delivery model. A final list of policy recommendations for optimal integration into the Thai healthcare system will be produced.
The aim is to identify a scalable model for delivery of DSME across Thailand.
Specific project objectives are:
1. To design a prototype of the DSME intervention
2. To refine the intervention prototype and trial design
3. To evaluate the effectiveness and cost-effectiveness of the intervention under two alternative modes of delivery (nurse-led and peer-led)
4. To identify the 'best buy' model for scale-up of DSME delivery in the Thai health system.
The primary hypothesis is that either model of DSME delivery will be effective and cost-effective, but the peer-led model will be a more scalable option for the Thai health system.
The two key research gaps in scientific literature that will be addressed are:
1. Clinical and cost-effectiveness of DSME programs in low- and middle-income countries, specifically Thailand
2. Role of peer programs in supporting complex behaviour change generally, and its implementation in low- and middle-income settings specifically.
The main expected outcomes are:
1. Development of a fully worked-up rapidly scalable model for DSME delivery in Thailand;
2. Capacity building of emerging Thai researchers and practitioners (nurses, village health volunteers) in the science and delivery of complex behavioural interventions, which could be expanded to other chronic conditions;
3. Long-term collaborative research links between UK and Thai researchers.
Study:
NCT03938233
Study Brief:
Protocol Section:
NCT03938233