Effect of Narrative Education on Glycemic Control in Adults With Type 2 Diabetes in Primary Care

December 26, 2025 updated by: Veli BİLEN, Mustafa Kemal University

Effect of a Structured Narrative Education Program on Glycemic Control in Adults With Type 2 Diabetes in Primary Care: A Randomized Controlled Trial

Type 2 diabetes is common in primary care, and daily self-care behaviors are essential for achieving blood sugar targets. This randomized, two-arm clinical trial will evaluate whether a structured narrative education program added to usual diabetes care improves glycemic control compared with usual care alone in adults with type 2 diabetes. Eligible participants (age ≥18 years) with suboptimal glycemic control (HbA1c ≥7.0% in the last 3 months) will be randomized 1:1 to either standard care or standard care plus narrative education. The narrative education program will be delivered by a family physician over 3 months and includes two individual face-to-face sessions (approximately 20-30 minutes) at Day 0 and Day 15 and four brief telephone reinforcement calls (approximately 3-5 minutes) on Days 30, 45, 60, and 75.

The primary outcome is the absolute change in HbA1c from baseline (Day 0) to Day 90. Secondary outcomes include changes in diabetes self-care activities (SDSCA-TR), diabetes-related distress (PAID-5-TR), and body mass index (BMI) from Day 0 to Day 90.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This single-center, parallel-group randomized controlled trial will be conducted in a primary care family health center. After eligibility assessment and written informed consent, participants will be randomized 1:1 to the Narrative Education Group (intervention) or the Standard Care Group (control). Randomization will be generated by an independent third person not involved in the conduct of the study using computer-based block randomization (block size 4 or 6). Allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes opened in the presence of the participant after consent. Because of the nature of the intervention, participants and the clinician delivering the sessions cannot be blinded; however, data entry and statistical analyses will be performed using coded groups.

Both groups will continue to receive routine diabetes management provided by the family physician and/or relevant specialists; the study protocol will not dictate medication initiation or changes. The control group will not receive any additional structured education sessions beyond routine counseling.

Participants in the intervention group will receive a structured narrative education program over approximately 3 months, consisting of two individual face-to-face sessions (about 20-30 minutes) at Day 0 and Day 15 and four brief telephone reinforcement calls (about 3-5 minutes) at Days 30, 45, 60, and 75. Face-to-face sessions emphasize the patient's personal experience of living with diabetes using open-ended reflective questions, with the goal of increasing awareness, identifying barriers, and setting small, achievable behavior goals. Telephone calls are used for reinforcement and appointment reminders; no measurements or questionnaires are administered during these calls.

Assessments will be performed at baseline (Day 0) and at 3 months (Day 90). At both time points, HbA1c and BMI will be recorded, and the SDSCA-TR and PAID-5-TR questionnaires will be administered. The primary outcome is the absolute change in HbA1c from Day 0 to Day 90. Secondary outcomes are changes in SDSCA-TR, PAID-5-TR, and BMI from Day 0 to Day 90. Process indicators (e.g., adherence to planned sessions and Day 90 follow-up rate) will also be reported.

Study Type

Interventional

Enrollment (Estimated)

226

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Diagnosis of type 2 diabetes mellitus for at least 1 year
  • HbA1c ≥ 7.0% measured within the last 3 months prior to enrollment
  • Followed in the study family health center and reachable by telephone
  • Able to read and write (or able to complete questionnaires with investigator assistance)
  • Provides written informed consent

Exclusion Criteria:

  • Type 1 diabetes, gestational diabetes, or secondary diabetes
  • Acute infection or hospitalization within the last 2 weeks
  • Major surgery or blood transfusion within the last 3 months
  • Active malignancy or current systemic steroid/immunosuppressive therapy
  • Significant cognitive impairment preventing participation
  • Current participation in another structured diabetes education program

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard Care
Participants receive usual diabetes care and routine counseling in primary care; no structured narrative education sessions are provided.
Experimental: Narrative Education + Standard Care
Participants receive usual care plus a structured narrative education program over 3 months (two individual face-to-face sessions at Day 0 and Day 15 and four brief reinforcement phone calls at Days 30, 45, 60, and 75).
Behavioral: Structured Narrative Education Program
Two individual face-to-face narrative sessions (20-30 minutes) at Day 0 and Day 15 plus four brief reinforcement phone calls (3-5 minutes) at Days 30, 45, 60, and 75 to support diabetes self-care goal setting and adherence.
Other Names:
  • Narrative Education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c (%)
Time Frame: Baseline (Day 0) to Day 90
Absolute change in glycated hemoglobin (HbA1c) from baseline (Day 0) to Day 90.
Baseline (Day 0) to Day 90

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Body Mass Index (BMI), kg/m²
Time Frame: Baseline (Day 0) to Day 90
Change in body mass index (BMI) calculated as weight (kg) / height (m²) from baseline (Day 0) to Day 90.
Baseline (Day 0) to Day 90
Change in Summary of Diabetes Self-Care Activities (SDSCA) total score
Time Frame: Baseline (Day 0) to Day 90
Summary of Diabetes Self-Care Activities (SDSCA), Turkish version (SDSCA-TR). The SDSCA is a self-report measure of diabetes self-care over the past 7 days. Total score range: 0 to 7, with higher scores indicating better self-care. The outcome is the change in SDSCA-TR total score from baseline (Day 0) to Day 90.
Baseline (Day 0) to Day 90
Change in Problem Areas in Diabetes (PAID-5) total score
Time Frame: Baseline (Day 0) to Day 90
Problem Areas in Diabetes - 5 item short form (PAID-5), Turkish version (PAID-5-TR). The PAID-5 assesses diabetes-related emotional distress. Total score range: 0 to 20, with higher scores indicating greater (worse) diabetes distress. The outcome is the change in PAID-5-TR total score from baseline (Day 0) to Day 90.
Baseline (Day 0) to Day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mustafa Kemal University

Investigators

  • Principal Investigator: Cahit ÖZER, MD, Mustafa Kemal University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 15, 2026

Primary Completion (Estimated)

November 15, 2026

Study Completion (Estimated)

November 15, 2026

Study Registration Dates

First Submitted

December 13, 2025

First Submitted That Met QC Criteria

December 13, 2025

First Posted (Estimated)

December 29, 2025

Study Record Updates

Last Update Posted (Actual)

December 31, 2025

Last Update Submitted That Met QC Criteria

December 26, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMKU-FM-NARRATIVE-T2DM-2026

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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