Набор скоро начнётся NCT07307430

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

Без фазы С лечением Type 2 Diabetes Mellitus (T2DM) Diabetes Self-management Diabetes Education

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Structured Narrative Education Program.
Кому может быть актуально: Состояния в реестре: Type 2 Diabetes Mellitus (T2DM), Diabetes Self-management, Diabetes Education. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Turkey (Türkiye)
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

Поведенческое 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.

Первичные конечные точки

Change in HbA1c (%) [Срок оценки: Baseline (Day 0) to Day 90]

Вторичные конечные точки (3)

Change in Summary of Diabetes Self-Care Activities (SDSCA) total score [Срок оценки: Baseline (Day 0) to Day 90]
Change in Problem Areas in Diabetes (PAID-5) total score [Срок оценки: Baseline (Day 0) to Day 90]
Change in Body Mass Index (BMI), kg/m² [Срок оценки: Baseline (Day 0) to Day 90]

Критерии участия

Критерии включения

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