A Scalable Solution for Delivery of Diabetes Self-Management Education in Thailand
试验速览
- 阶段
- 不适用
- 入组人数
- 693
- 主要终点
- Hemoglobin A1c levels (HbA1c)
研究概览
简要总结
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.
详细描述
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:
- To design a prototype of the DSME intervention
- To refine the intervention prototype and trial design
- To evaluate the effectiveness and cost-effectiveness of the intervention under two alternative modes of delivery (nurse-led and peer-led)
- To identify the 'best buy' model for scale-up of DSME delivery in the Thai health system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •People aged over 18 years with a new referral for type-2 diabetes management at the 15 hospitals
- •People aged over 18 years with difficulties managing type-2 diabetes up to three years of diagnosis at the 15 hospitals
- •Willingness to attend educational group meetings
- •Available for 12-month follow-up
排除标准
- •Advanced diabetes complications such as receiving dialysis, registered blind, above ankle amputations.
- •Co-morbid learning difficulties, dementia or severe mental illness
- •Lacking the capacity to consent
- •Those aged under 18 years.
结局指标
主要结局
Hemoglobin A1c levels (HbA1c)
时间窗: 12 months
HbA1c will measures the average blood glucose (sugar) levels months
Total cardiovascular risk
时间窗: 12 months
The cardiovascular risk will be estimated by Systemic Coronary Risk Evaluation. (SCORE) model. This is a range from 120 to 180 measuring systolic blood pressure (mmHq).
次要结局
- EQ-5D(12 months)
- Hospital Anxiety and Depression scale (HADS)(12 months)
- Perceived Stress Questionnaire (PSQ)(12 months)
- Summary of Diabetes Self-Care Activities Assessment (SDSCA)(12 months)
- International Physical Activity Questionnaire(12 months)
- Body mass index (BMI)(12 months)