Type 2 Diabetes Mellitus (T2DM)NCT07307430
Effect of Narrative Education on Glycemic Control in Adults With Type 2 Diabetes in Primary Care
A study testing Structured Narrative Education Program in people with Type 2 Diabetes Mellitus (T2DM) and Diabetes Self-management, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Diabetes Self-management, Diabetes Education
- What is being tested?
- Structured Narrative Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2026to 15 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ozerli Family Health Center No. 4
Antakya, Hatay, 31600
veli bilen, MD, +90 507 958 61 25, velibilen@hotmail.com
About this study
Official title: 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.
Read the 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.
- Being tested
- Structured Narrative Education Program
- Keywords
- Primary care, Narrative education, Diabetes self-management, HbA1c, Randomized controlled trial, Self-care behaviors, SDSCA, PAID-5, Family medicine, Behavioral intervention
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Narrative Education ProgramBehavioural
Also called Narrative Education
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Structured Narrative Education Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c (%)
Absolute change in glycated hemoglobin (HbA1c) from baseline (Day 0) to Day 90.
Measured: Baseline (Day 0) to Day 90
Secondary outcomes (3)
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.
Measured: Baseline (Day 0) to Day 90
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.
Measured: Baseline (Day 0) to Day 90
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.
Measured: Baseline (Day 0) to Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start15 Feb 2026 (estimated)
- Primary completion15 Nov 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm, parallel-group design with 1:1 assignment to standard care versus structured narrative education plus standard care.
- Masking
- None (open label)
- Enrolment
- 226 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mustafa Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veli BİLEN, Mustafa Kemal University
- Investigators
- Cahit ÖZER, MD, Principal investigator, Mustafa Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07307430
- Sponsor's protocol ID
- HMKU-FM-NARRATIVE-T2DM-2026
- Status last verified
- Dec 2025
- First submitted
- 13 Dec 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Structured Narrative Education Program on Glycemic Control in Adults With Type 2 Diabetes in Primary Care: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07307430
- Acronym / sponsor ID
- HMKU-FM-NARRATIVE-T2DM-2026
- Keywords
- Primary care, Narrative education, Diabetes self-management, HbA1c, Randomized controlled trial, Self-care behaviors, SDSCA, PAID-5
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 226 participants (estimated)
- Lead sponsor
- Mustafa Kemal UniversityUniversity, hospital or other
- Study start
- 15 Feb 2026 (estimated)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm, parallel-group design with 1:1 assignment to standard care versus structured narrative education plus standard care.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Structured Narrative Education ProgramParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Narrative Education ProgramAlso: Narrative EducationTwo 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. | Behavioural | Narrative Education + Standard Care |
Primary outcome
Change in HbA1c (%)
Time frame: Baseline (Day 0) to Day 90
Absolute change in glycated hemoglobin (HbA1c) from baseline (Day 0) to Day 90.
3 secondary outcomes
Change in Summary of Diabetes Self-Care Activities (SDSCA) total score
Time frame: Baseline (Day 0) to Day 90
Change in Problem Areas in Diabetes (PAID-5) total score
Time frame: Baseline (Day 0) to Day 90
Change in Body Mass Index (BMI), kg/m²
Time frame: Baseline (Day 0) to Day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cahit ÖZER, MD principal investigator
Mustafa Kemal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Narrative Education Program in people with Type 2 Diabetes Mellitus (T2DM) and Diabetes Self-management, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Veli BİLEN, MD (+90 507 958 61 25, velibilen@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (%) (time frame: Baseline (Day 0) to Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.