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

NCT07307430 | Not Yet Recruiting DMC

• 1 other identifier: HMKU-FM-NARRATIVE-T2DM-2026
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus (T2DM); Diabetes Self-management; Diabetes Education

Keywords

Primary care; Narrative education; Diabetes self-management; HbA1c; Randomized controlled trial; Self-care behaviors; SDSCA; PAID-5; Family medicine; Behavioral intervention

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c (%)

  Absolute change in glycated hemoglobin (HbA1c) from baseline (Day 0) to Day 90.

  Baseline (Day 0) to Day 90

Secondary Outcomes (3)

• Change in Summary of Diabetes Self-Care Activities (SDSCA) total score

  Baseline (Day 0) to Day 90

• Change in Problem Areas in Diabetes (PAID-5) total score

  Baseline (Day 0) to Day 90

• Change in Body Mass Index (BMI), kg/m²

  Baseline (Day 0) to Day 90

Study Arms (2)

Standard Care

NO INTERVENTION

Participants receive usual diabetes care and routine counseling in primary care; no structured narrative education sessions are provided.

Narrative Education + Standard Care

EXPERIMENTAL

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

Interventions

Structured Narrative Education Program BEHAVIORAL

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.

Also known as: Narrative Education

Narrative Education + Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mustafa Kemal University: lead

Study Sites (1)

Ozerli Family Health Center No. 4

Antakya, Hatay, 31600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Cahit ÖZER, MD

  Mustafa Kemal University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Veli BİLEN, MD

CONTACT

+90 507 958 61 25; velibilen@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the intervention, participants and care providers are not blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: Two-arm, parallel-group design with 1:1 assignment to standard care versus structured narrative education plus standard care.

Study Record Dates

• First Submitted: December 13, 2025
• First Posted: December 29, 2025
• Study Start: February 15, 2026
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

TU (1)