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

NCT ID: NCT07307430

Last Updated: 2025-12-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 226 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-15
• Study Completion Date: 2026-11-15

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.

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.

Conditions

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

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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).

Group Type: EXPERIMENTAL

Structured Narrative Education Program

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Narrative Education

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mustafa Kemal University

OTHER

Sponsor Role: lead

Responsible Party

Veli BİLEN

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cahit ÖZER, MD

Role: PRINCIPAL_INVESTIGATOR

Mustafa Kemal University

Locations

Ozerli Family Health Center No. 4

Antakya, Hatay, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Veli BİLEN, MD

Role: CONTACT

Phone: +90 507 958 61 25

Email: velibilen@hotmail.com

Facility Contacts

veli bilen, MD

Role: primary

Other Identifiers

HMKU-FM-NARRATIVE-T2DM-2026

Identifier Type: -

Identifier Source: org_study_id