The Effectiveness of Diabetes Self-Management Intervention on Glycemic Control, Self-management and Psychological Distress for Ethnic Minority Elderly in Rural Areas in Thailand: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
研究概览
简要总结
Type 2 diabetes is a serious health condition that affects many older adults from ethnic minority communities in Northern Thailand. These populations, often referred to as hill tribes, include groups such as Akha, Lahu, Hmong, and Lisu who live in remote mountainous areas of Chiang Rai Province. Previous research has found that the prevalence of type 2 diabetes among ethnic minority elderly in Thailand is 16.8%, which is higher than the general Thai population. Many of these individuals have difficulty managing their diabetes because of low literacy, limited access to healthcare, language barriers, and poverty.
The purpose of this study was to test whether a structured Diabetes Self-Management (DSM) program could help ethnic minority older adults (aged 60 years or older) improve their blood sugar control, increase their ability to manage diabetes on their own, and reduce emotional distress related to diabetes.
This study used a cluster randomized controlled trial design. Villages in Chiang Rai Province were randomly assigned to either the DSM intervention group or the usual care group. A total of 108 participants (54 per group) were enrolled. Participants in the intervention group attended a 6-week education program with weekly interactive sessions covering diabetes knowledge, healthy eating, physical activity, medication management, problem solving, risk reduction, and emotional coping. Two home visits were also provided at Weeks 8 and 10. Participants in the usual care group received standard brief discharge education and routine follow-up visits.
The main outcome measured was the change in HbA1c (a blood test that shows average blood sugar levels over the past 2 to 3 months) from the start of the study to 12 weeks later. Additional outcomes included changes in diabetes self-management behaviors and diabetes-related psychological distress, measured using validated questionnaires.
详细描述
This study employed a cluster randomized controlled trial (cRCT) design to evaluate the effectiveness of a culturally tailored Diabetes Self-Management (DSM) intervention among ethnic minority elderly (EME) aged 60 years or older with type 2 diabetes mellitus (T2DM) in rural Chiang Rai Province, Northern Thailand.
BACKGROUND AND RATIONALE:
Ethnic minority populations in Northern Thailand, commonly referred to as hill tribes, experience disproportionately high rates of T2DM compared to the general Thai population. These communities face multiple barriers to effective diabetes management, including geographic isolation, low health literacy, limited Thai language proficiency, cultural differences in health beliefs, and restricted access to healthcare services. Despite the well-established evidence supporting diabetes self-management education for improving glycemic outcomes, few interventions have been designed specifically for low-literacy, culturally diverse elderly populations in low-resource rural settings.
THEORETICAL FRAMEWORK:
The DSM intervention was developed based on the Chronic Care Model (CCM), which emphasizes patient-centered care through self-management support, community resource linkage, health system integration, clinical information systems, and decision support. The intervention content was informed by the seven core self-management skills defined by the American Association of Diabetes Educators (AADE7): healthy eating, being active, monitoring, taking medications, problem solving, reducing risks, and healthy coping.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors who collected HbA1c blood samples and administered the DSMQ and DDS-17 questionnaires were blinded to participant group allocation. These assessors were independent from the healthcare providers who delivered the intervention and did not work in the sub-district health promoting hospitals where the intervention was conducted. Blinding of participants and intervention providers was not feasible due to the nature of the behavioral education program.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ethnic minority elderly aged 60 years or older residing in rural mountainous villages in Chiang Rai Province, Northern Thailand (including Akha, Lahu, Hmong, and Lisu communities)
- •Diagnosed with type 2 diabetes mellitus (T2DM) for at least one year
- •HbA1c level greater than 6.5%
- •Mini-Mental State Examination (MMSE) score of 24 or higher
- •Ability to communicate in Thai language
- •Willing and able to provide written informed consent or thumbprint with witness signature
排除标准
- •Unable to complete the informed consent process
- •Mini-Mental State Examination (MMSE) score below 24, indicating possible cognitive impairment
- •Severe or unstable medical conditions that would preclude participation in a 6-week group education program (e.g., acute hospitalization, severe mobility limitations requiring full-time assistance)
- •Currently participating in another diabetes education or self-management intervention study