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.

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.

RANDOMIZATION AND ALLOCATION:

Eighteen villages with ethnic minority populations were identified and stratified into two groups of nine villages each based on geographical region, proportion of ethnic minority residents, and expected T2DM caseloads. Villages were randomly allocated in a 1:1 ratio to either the DSM intervention arm or the usual care control arm. The randomization sequence was generated by an independent statistician using a computer-based random number generator. Allocation concealment was maintained through sealed opaque envelopes opened only after each village confirmed participation. Recruitment within villages was completed prior to revealing allocation to recruiters to minimize recruitment bias.

INTERVENTION ARM:

Participants in the intervention arm received a 6-week structured DSM program consisting of one interactive session per week, each lasting 1 to 3 hours. Sessions were delivered by a multidisciplinary team including endocrinologists, nurse practitioners, dieticians, and village health volunteers (VHVs). Teaching methods were specifically adapted for low-literacy populations and incorporated visual flipcharts, picture-based symptom diaries with color codes and symbols, hands-on food demonstrations using locally available ingredients, glucometer training, role-play scenarios, and group discussions conducted with native-language translation support from VHVs.

Week 1 focused on diabetes fundamentals and symptom management, including recognition of hypoglycemia, hyperglycemia, and emotional distress. Week 2 addressed culturally appropriate healthy eating using the plate model and hand method for portion control. Week 3 introduced safe physical activities adapted for elderly bodies, including walking, stretching, and light gardening. Week 4 covered medication adherence and blood glucose self-monitoring with hands-on glucometer practice. Week 5 addressed problem solving and risk reduction through case-scenario role-plays for hypoglycemia management and daily foot care. Week 6 focused on healthy coping strategies, stress management, and effective use of local healthcare services.

Following the 6-week workshop phase, two home visits were conducted at Weeks 8 and 10 by nurses and VHVs to reinforce skills, review symptom and diet records, check medication adherence, and provide emotional support.

CONTROL ARM:

Participants in the control arm received standard usual care consisting of a one-time 10 to 15 minute face-to-face discharge education session delivered by a nurse practitioner not involved in the study intervention. Content included general information about T2DM, dietary advice, exercise recommendations, risk factor awareness, and self-monitoring instructions. No teach-back method, interactive activities, or structured follow-up education was provided. Participants attended scheduled outpatient follow-up visits as per the routine hospital system.

CONTAMINATION PREVENTION:

Separate teams delivered the intervention and control activities, and sessions were scheduled independently across clusters to minimize the risk of contamination between groups.

BLINDING:

Participants and intervention providers could not be blinded due to the nature of the behavioral intervention. Outcome assessors who collected HbA1c measurements and administered questionnaires were blinded to group allocation and were not involved in intervention delivery.

OUTCOME ASSESSMENT:

All outcomes were assessed at baseline (Week 0) and at 12 weeks after the start of the intervention. The primary outcome was change in glycated hemoglobin (HbA1c), measured via blood test at sub-district health promoting hospitals. Secondary outcomes included change in diabetes self-management behaviors measured by the Diabetes Self-Management Questionnaire (DSMQ, Thai version, 30 items across five domains, scored 30 to 150), and change in diabetes-related psychological distress measured by the 17-item Diabetes Distress Scale (DDS-17, four dimensions, 6-point Likert scale).

SAMPLE SIZE:

The sample size was calculated based on an effect size of 0.77 from a previous related study, with a significance level of 0.05 and statistical power of 0.90, yielding 45 participants per group. After accounting for an anticipated 20% attrition rate, 54 participants per group (108 total) were required.

STATISTICAL ANALYSIS:

Baseline demographic characteristics were described using means and standard deviations for continuous variables and frequencies and percentages for categorical variables. Paired t-tests and independent t-tests were used to compare within-group and between-group differences in study outcomes.

ETHICAL CONSIDERATIONS:

The study was approved by the Chiang Rai Province Public Health Research Ethics Committee (Approval No. CRPPHO 059/2568) and the Taipei Medical University-Joint Institutional Review Board (Approval No. N202511006). All procedures adhered to the principles of the Declaration of Helsinki. Gatekeeper consent was obtained from village leaders and local health staff prior to enrollment. Written informed consent or a thumbprint with a witness signature was obtained from each participant.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

The datasets generated during the current study are not publicly available due to the small sample size and the potential risk of re-identification of participants from a vulnerable ethnic minority population in a geographically identifiable rural area. De-identified data may be available from the corresponding author upon reasonable request and subject to ethical approval from the Chiang Rai Province Public Health Research Ethics Committee (CRPPHO) and the Taipei Medical University-Joint Institutional Review Board (TMU-JIRB).

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.