Type 2 Diabetes Mellitus (T2DM)
Conditions
Brief summary
This randomized controlled trial aims to develop and evaluate a telenursing-based Diabetes Self-Management Education and Support (DSMES) program with uncontrolled type 2 diabetes mellitus in Thailand. The program is designed to improve diabetes self-management through nurse-led education, behavioral support, and regular follow-up delivered via telecommunication technologies. Participants with type 2 diabetes and poor glycemic control will be randomly assigned to either an intervention group receiving a 12-week telenursing DSMES program or a control group receiving usual care. The intervention includes an initial in-person education session followed by structured video call follow-ups provided by nurse. The primary outcome of this study is the feasibility of implementing telenursing for DSMES in Thailand. Secondary outcomes include changes in glycemic control (HbA1C , FBG), blood pressure, body mass index, diabetes knowledge, self-care behaviors, coping behaviors, quality of life, healthcare costs, and frequency of acute care use. The findings from this study are expected to provide evidence to support the use of telenursing as an accessible and sustainable approach for diabetes self-management in the Thai healthcare context.
Interventions
BEHAVIORALTelenursing-Based Diabetes Self-Management Education and Support
This intervention is a nurse-led, telenursing-based Diabetes Self-Management Education and Support (DSMES) program delivered over a 12-week period. It includes an initial face-to-face diabetes education session followed by scheduled follow-up sessions conducted via video calls. The program focuses on improving diabetes self-management through education, behavioral support, goal setting, problem-solving, and ongoing monitoring tailored to individual patient needs.
Sponsors
Chiang Mai University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* People with T2DM * Adults (age 20-64) and older adults (65 and above) * Uncontrolled diabetes, as determined by physician based on the diagnostic criteria of HbA1C \> 7% * Can read and write * Own a smartphone * Having internet connectivity * Able to receive a video call or with assistance from a caregiver
Exclusion criteria
* Insulin-dependent patients * Cognitive or mobility impairments , as assessed by the Thai Mental State Examination (TMSE). A TMSE score below 24 was considered indicative of cognitive impairment (The Nurse Association of Thailand, 2025). * Requiring special nursing care, such as patients with severe diabetic complications or those who are bedridden. * Previous extensive DSMES exposure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of telenursing for diabetes self-management education and support (DSMES) | at 12-week follow-up period after enrollment | Feasibility outcomes, including participation rate, completion rate, and adherence level, were analyzed using descriptive statistics under the per-protocol (PP) approach, which included only participants who completed all study assessments. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycated hemoglobin (HbA1c) level | From baseline to 12 weeks after enrollment | HbA1c (%) will be measured using standard laboratory methods obtained from medical records at baseline and 12 weeks after enrollment to assess changes over time. |
| Fasting Blood Glucose (FBG) | From baseline to 12 weeks after enrollment | FBG (mg/dl) will be measured using standard laboratory methods obtained from medical records at baseline and 12 weeks after enrollment to assess changes over time. |
| Blood pressure (BP) | From baseline to 12 weeks after enrollment | Blood pressure will be obtained from health assessment record at baseline and 12 weeks after enrollment to assess changes over time. |
| Body Mass Index (BMI) | From baseline to 12 weeks after enrollment | Body mass index (kg/m²) will be calculated from measured weight and height obtained from health assessment record at baseline and 12 weeks after enrollment to assess changes over time. |
| Diabetes knowledge | From baseline to 6 weeks and 12 weeks after enrollment | Diabetes knowledge will be assessed using the Thai version of the Diabetes Knowledge Scale (DIAKS), consisting of 21 items with true, false, or don't know response options. Total scores will be calculated based on the number of correct responses. Assessments will be conducted at baseline, 6 weeks, and 12 weeks after enrollment to assess changes over time. |
| Self-care behavior | From baseline to 6 weeks and 12 weeks after enrollment | Self-care behavior will be assessed using the Thai Diabetes Self-Management Questionnaire-Revised (T-DSMQ-R). Total scores will be calculated according to standard scoring procedures, with higher scores indicating better diabetes self-management. Assessments will be conducted at baseline, 6 weeks, and 12 weeks after enrollment to assess changes over time. |
| Positive coping behavior | From baseline to 6 weeks and 12 weeks after enrollment | Positive coping behavior will be assessed using the Short Thai Stress Test (ST-5), a five-item questionnaire rated on a 0-3 Likert scale. Total scores range from 0 to 15, with higher scores indicating greater stress severity. Assessments will be conducted at baseline, 6 weeks, and 12 weeks after enrollment to assess changes over time. |
| Quality of life (QoL) | From baseline to 6 weeks and 12 weeks after enrollment | Quality of life will be assessed using the Thai version of the Audit of Diabetes-Dependent Quality of Life (ADDQoL19). The average weighted impact (AWI) score will be calculated, with scores ranging from -9 to +3. Assessments will be conducted at baseline, 6 weeks, and 12 weeks after enrollment to assess changes over time. |
| Healthcare costs | at 12-week follow-up period after enrollment | Healthcare costs will be assessed through review of medical and financial records, including outpatient visits, inpatient admissions, medications, laboratory tests, and other diabetes-related expenses. Total healthcare costs per participant will be summarized for the 12-week follow-up period. |
| Frequency of acute care use | at 12-week follow-up period after enrollment | Frequency of acute care use will be assessed using hospital records, including emergency department visits and hospital admissions. The total number of acute care events per participant will be recorded during the follow-up period. |
| All-cause mortality | at 12-week follow-up period after enrollment | All-cause mortality will be assessed using hospital follow-up records. Mortality status will be recorded for each participant during the follow-up period. |
Countries
Thailand
Outcome results
None listed