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Completed

NCT Number: NCT07366775

A Telenursing Program to Support Diabetes Self-Management

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nong Pa Khrang Municipal Hospital

Chiang Mai, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telenursing-Based Diabetes Self-Management Education and Support

Behavioral

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.

Primary outcomes

  1. Feasibility of telenursing for diabetes self-management education and support (DSMES)

    Time frame: 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 outcomes

  1. Glycated hemoglobin (HbA1c) level

    Time frame: 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.

  2. Fasting Blood Glucose (FBG)

    Time frame: 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.

  3. Blood pressure (BP)

    Time frame: 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.

  4. Body Mass Index (BMI)

    Time frame: 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.

  5. Diabetes knowledge

    Time frame: 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.

  6. Self-care behavior

    Time frame: 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.

  7. Positive coping behavior

    Time frame: 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.

  8. Quality of life (QoL)

    Time frame: 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.

  9. Healthcare costs

    Time frame: 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.

  10. Frequency of acute care use

    Time frame: 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.

  11. All-cause mortality

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Chiang Mai University

Other

Registry information

Official study title

Development of Telenursing for Diabetes Self-Management Education and Support (DSMES) Among Patients With Type 2 Diabetes Mellitus in Thailand: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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