Effect of Narrative Education on Glycemic Control in Adults With Type 2 Diabetes in Primary Care
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMustafa Kemal University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Structured Narrative Education Program
BehavioralTwo 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.
Treatment groups
226 Participants
are divided into 2 treatment groupsGroup A: Standard CareNo intervention 0 interventions
Group B: Narrative Education + Standard CareExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in HbA1c (%)
Absolute change in glycated hemoglobin (HbA1c) from baseline (Day 0) to Day 90.
Time frame
Baseline (Day 0) to Day 90Secondary outcomes
1
Change in Summary of Diabetes Self-Care Activities (SDSCA) total score
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.
Time frame
Baseline (Day 0) to Day 902
Change in Problem Areas in Diabetes (PAID-5) total score
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.
Time frame
Baseline (Day 0) to Day 903
Change in Body Mass Index (BMI), kg/m²
Change in body mass index (BMI) calculated as weight (kg) / height (m²) from baseline (Day 0) to Day 90.
Time frame
Baseline (Day 0) to Day 90Sponsors and contacts
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Source ClinicalTrials.gov
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