- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07366775
A Telenursing Program to Support Diabetes Self-Management
Development of Telenursing for Diabetes Self-Management Education and Support (DSMES) Among Patients With Type 2 Diabetes Mellitus in Thailand: A Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Chiang Mai, Thailand
- Nong Pa Khrang Municipal Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Telenursing-Based DSMES Program
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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.
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No Intervention: Usual care
control group : receive usual care
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of telenursing for diabetes self-management education and support (DSMES)
Time Frame: at 12-week follow-up period after enrollment
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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.
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at 12-week follow-up period after enrollment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Healthcare costs
Time Frame: at 12-week follow-up period after enrollment
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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.
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at 12-week follow-up period after enrollment
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Frequency of acute care use
Time Frame: at 12-week follow-up period after enrollment
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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.
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at 12-week follow-up period after enrollment
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All-cause mortality
Time Frame: at 12-week follow-up period after enrollment
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All-cause mortality will be assessed using hospital follow-up records.
Mortality status will be recorded for each participant during the follow-up period.
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at 12-week follow-up period after enrollment
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Glycated hemoglobin (HbA1c) level
Time Frame: From baseline to 12 weeks after enrollment
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HbA1c (%) will be measured using standard laboratory methods obtained from medical records at baseline and 12 weeks after enrollment to assess changes over time.
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From baseline to 12 weeks after enrollment
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Fasting Blood Glucose (FBG)
Time Frame: From baseline to 12 weeks after enrollment
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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.
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From baseline to 12 weeks after enrollment
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Blood pressure (BP)
Time Frame: From baseline to 12 weeks after enrollment
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Blood pressure will be obtained from health assessment record at baseline and 12 weeks after enrollment to assess changes over time.
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From baseline to 12 weeks after enrollment
|
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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.
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From baseline to 12 weeks after enrollment
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Diabetes knowledge
Time Frame: From baseline to 6 weeks and 12 weeks after enrollment
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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.
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From baseline to 6 weeks and 12 weeks after enrollment
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Self-care behavior
Time Frame: From baseline to 6 weeks and 12 weeks after enrollment
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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.
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From baseline to 6 weeks and 12 weeks after enrollment
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Positive coping behavior
Time Frame: From baseline to 6 weeks and 12 weeks after enrollment
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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.
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From baseline to 6 weeks and 12 weeks after enrollment
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Quality of life (QoL)
Time Frame: From baseline to 6 weeks and 12 weeks after enrollment
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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.
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From baseline to 6 weeks and 12 weeks after enrollment
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2568-EXP092
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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