Effectiveness of a Diabetes Self-Management Program Among Ethnic Minority Elderly in Rural Thailand

NCT07669389 | Completed

• 2 other identifiers: TMU-JIRB: N202511006CRPPHO 059/2568
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus (T2DM); Psychological Distress; Hyperglycemia

Keywords

Diabetes Self-Management; Ethnic Minority Elderly; Glycemic Control; HbA1c; Diabetes Distress; Hill Tribe; Self-Management Education

Outcome Measures

Primary Outcomes (1)

• Change in Glycated Hemoglobin (HbA1c)

  Change in HbA1c level (%) from baseline to 12 weeks. HbA1c was measured via venous blood sample collected at sub-district health promoting hospitals (SDHPHs) by nurse practitioners. HbA1c reflects average blood glucose control over the preceding 2 to 3 months. A decrease in HbA1c indicates improved glycemic control.

  Baseline (Week 0) and 12 weeks after the start of the intervention

Secondary Outcomes (2)

• Change in Diabetes Self-Management Behaviors (DSMQ)

  Baseline (Week 0) and 12 weeks after the start of the intervention

• Change in Diabetes-Related Psychological Distress (DDS-17)

  Baseline (Week 0) and 12 weeks after the start of the intervention

Study Arms (2)

Diabetes Self-Management Intervention Group

EXPERIMENTAL

Participants in villages allocated to the intervention arm received a 6-week structured Diabetes Self-Management Education (DSME) program consisting of weekly interactive sessions (1 to 3 hours each) delivered by a multidisciplinary team including endocrinologists, nurse practitioners, dieticians, and village health volunteers. Content covered seven core self-management skills: symptom management, healthy eating, physical activity, medication adherence and glucose monitoring, problem solving, risk reduction, and healthy coping. Teaching methods were adapted for low-literacy populations using visual flipcharts, picture-based diaries, food demonstrations, hands-on glucometer training, role-play scenarios, and native-language translation support. Two follow-up home visits were conducted at Weeks 8 and 10 for skills reinforcement and emotional support.

Behavioral: Diabetes Self-Management Education (DSME) Program

Usual Care Control Group

ACTIVE COMPARATOR

Participants in villages allocated to the control arm received standard usual care provided by local health services. This consisted 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 type 2 diabetes, dietary advice, exercise recommendations, risk factor awareness, and self-monitoring instructions. No teach-back method, interactive activities, structured follow-up education, or home visits were provided. Participants attended scheduled outpatient follow-up visits as per the routine hospital system.

Other: Usual Care

Interventions

Diabetes Self-Management Education (DSME) Program BEHAVIORAL

A culturally tailored 6-week diabetes self-management education program grounded in the Chronic Care Model and the seven core self-management skills defined by the American Association of Diabetes Educators. The program consisted of six weekly interactive group sessions: Week 1 covered diabetes fundamentals and symptom management; 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 participants; Week 4 focused on medication adherence and blood glucose self-monitoring with hands-on glucometer practice; Week 5 addressed problem solving and risk reduction through role-play scenarios for hypoglycemia management and daily foot care; Week 6 covered healthy coping strategies, stress management, and effective use of local healthcare services. Sessions were delivered by endocrinologists, nurse practitioners, dieticians, and village health volunteers who provided native-la

Diabetes Self-Management Intervention Group

Usual Care OTHER

Standard guideline-based discharge education for type 2 diabetes consisting of a one-time 10 to 15 minute face-to-face verbal education session delivered by a nurse practitioner not involved in the study intervention. Content included basic knowledge of type 2 diabetes, general dietary advice, exercise recommendations, risk factor awareness, complication prevention guidance, and self-monitoring instructions. A hospital-provided leaflet was given if available. No interactive activities, teach-back method, structured follow-up education, or home visits were included. Participants attended routine outpatient follow-up visits as scheduled by the hospital system.

Usual Care Control Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Medical University: lead
• Mae Fah Luang University: collaborator
• Chiang Rai Public Health Office: collaborator

Study Sites (1)

Sub-district Health Promoting Hospitals (SDHPHs), Chiang Rai Province

Chiang Rai, Changwat Chiang Rai, 57100, Thailand

Location

Related Publications (6)

• Lorig KR, Holman H. Self-management education: history, definition, outcomes, and mechanisms. Ann Behav Med. 2003 Aug;26(1):1-7. doi: 10.1207/S15324796ABM2601_01.

  PMID: 12867348 RESULT

• Saeedi P, Petersohn I, Salpea P, Malanda B, Karuranga S, Unwin N, Colagiuri S, Guariguata L, Motala AA, Ogurtsova K, Shaw JE, Bright D, Williams R; IDF Diabetes Atlas Committee. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract. 2019 Nov;157:107843. doi: 10.1016/j.diabres.2019.107843. Epub 2019 Sep 10.

  PMID: 31518657 RESULT

• Thanakwang K, Thinganjana W, Konggumnerd R. Psychometric properties of the Thai version of the Diabetes Distress Scale in diabetic seniors. Clin Interv Aging. 2014 Aug 16;9:1353-61. doi: 10.2147/CIA.S67200. eCollection 2014.

  PMID: 25152617 RESULT

• Powers MA, Bardsley JK, Cypress M, Funnell MM, Harms D, Hess-Fischl A, Hooks B, Isaacs D, Mandel ED, Maryniuk MD, Norton A, Rinker J, Siminerio LM, Uelmen S. Diabetes Self-management Education and Support in Adults With Type 2 Diabetes: A Consensus Report of the American Diabetes Association, the Association of Diabetes Care & Education Specialists, the Academy of Nutrition and Dietetics, the American Academy of Family Physicians, the American Academy of PAs, the American Association of Nurse Practitioners, and the American Pharmacists Association. Diabetes Care. 2020 Jul;43(7):1636-1649. doi: 10.2337/dci20-0023. Epub 2020 Jun 8. No abstract available.

  PMID: 32513817 RESULT

• Wagner EH, Austin BT, Davis C, Hindmarsh M, Schaefer J, Bonomi A. Improving chronic illness care: translating evidence into action. Health Aff (Millwood). 2001 Nov-Dec;20(6):64-78. doi: 10.1377/hlthaff.20.6.64.

  PMID: 11816692 RESULT

• Apidechkul T. Prevalence and factors associated with type 2 diabetes mellitus and hypertension among the hill tribe elderly populations in northern Thailand. BMC Public Health. 2018 Jun 5;18(1):694. doi: 10.1186/s12889-018-5607-2.

  PMID: 29871598 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hyperglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study used a cluster randomized controlled trial design in which villages (clusters) were randomly allocated to either the Diabetes Self-Management intervention arm or the usual care control arm. Individual participants within each village received the intervention assigned to their village. Stratification was applied based on geographical region, proportion of ethnic minority populations, and expected T2DM caseloads to enhance comparability between arms.

Study Record Dates

• First Submitted: June 21, 2026
• First Posted: June 25, 2026
• Study Start: November 20, 2025
• Primary Completion: February 19, 2026
• Study Completion: February 19, 2026
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)