NCT07366775

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, 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress79%
Feb 2026May 2026

First Submitted

Initial submission to the registry

January 7, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

February 25, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2026

Last Updated

March 24, 2026

Status Verified

January 1, 2026

Enrollment Period

3 months

First QC Date

January 7, 2026

Last Update Submit

March 20, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

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

    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.

    at 12-week follow-up period after enrollment

Secondary Outcomes (9)

  • Glycated hemoglobin (HbA1c) level

    From baseline to 12 weeks after enrollment

  • Body Mass Index (BMI)

    From baseline to 12 weeks after enrollment

  • Change from baseline in diabetes knowledge score measured by the Diabetes Knowledge Scale (DIAKS)

    From baseline to 6 weeks and 12 weeks after enrollment

  • Self-care behavior

    From baseline to 6 weeks and 12 weeks after enrollment

  • Positive coping behavior

    From baseline to 6 weeks and 12 weeks after enrollment

  • +4 more secondary outcomes

Study Arms (2)

Telenursing-Based DSMES Program

EXPERIMENTAL
Behavioral: Telenursing-Based Diabetes Self-Management Education and Support

Usual care

NO INTERVENTION

control group : receive usual care

Interventions

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.

Telenursing-Based DSMES Program

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nong Pa Khrang Municipal Hospital

Chiang Mai, Thailand

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Lecturer

Study Record Dates

First Submitted

January 7, 2026

First Posted

January 26, 2026

Study Start

February 25, 2026

Primary Completion (Estimated)

May 27, 2026

Study Completion (Estimated)

May 27, 2026

Last Updated

March 24, 2026

Record last verified: 2026-01

Locations