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Набор скоро начнётся NCT06635460

Motivational Interviewing and WhatsApp-Based Monitoring for Metabolic Control and Self-Efficacy in Adolescents With T1DM

Без фазы С лечением Type 1 Diabetes Mellitus (T1DM) Motivational Interviewing Metabolic Control

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: Motivational interviewing, Social media-based patient monitoring.
Кому может быть актуально
Состояния в реестре: Type 1 Diabetes Mellitus (T1DM), Motivational Interviewing, Metabolic Control. Базовые параметры: 13 лет — 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 →
Официальное название

The Impact of Motivational Interviewing and Social Media-Based Patient Monitoring on Metabolic Control and Self-Efficacy in Adolescents With Type 1 Diabetes: A Randomized Controlled Trial

Обзор

This clinical study aims to determine the effects of motivational interviewing and social media-based patient monitoring on metabolic control and self-efficacy in adolescents with Type 1 diabetes. Additionally, the study will assess the adolescents\' attitudes toward their disease, quality of life, and perceived levels of social support. The primary research questions are as follows: For adolescents with Type 1 diabetes who receive motivational interviewing and social media-based monitoring: How do their attitudes toward their disease compare to those in the control group? How do their perceived levels of social support compare to those in the control group? How do their self-efficacy levels compare to those in the control group? How does their quality of life compare to that of the control group? How do their HbA1c levels compare to those in the control group?

Подробное описание

One of the most common chronic diseases in adolescence is type 1 diabetes mellitus (T1DM). T1DM is one of the most common endocrine diseases of childhood and requires lifelong management. To minimize the impact of T1DM on adolescents, metabolic control should be ensured, self-efficacy should be gained, quality of life should be improved, and anxiety should be reduced.

Because the epidemiology, pathophysiology, developmental status, and response to diabetes treatment are different in adolescents than in adults with diabetes, the care of adolescents should be different from that of adults. This population should be managed by a multidisciplinary team trained in pediatric diabetes management and sensitive to the difficulties of adolescents with T1DM. The diabetes nurse in this team is responsible for providing diabetes self-management education and support, medical nutrition therapy, and psychosocial support during and regularly after diagnosis. Interventions should focus on empowering adolescents to better manage their disease. Educational programs should include approaches such as teaching specific diabetes management skills and developing independence in these tasks (e.g., carbohydrate counting, blood glucose monitoring) and promoting autonomy and motivation.

Motivational interviewing techniques can be used to elicit behavior change by helping patients identify and resolve ambivalent feelings. Motivational interviewing is defined as a collaborative approach that elicits intrinsic motivation and strengthens commitment to behavior change goals. Motivating patients makes them feel ready to change their behavior and ensures that interventions to improve diabetes management are effective. Recent studies have shown that motivational interviewing also has a positive impact on diabetes self-management.

Today, social media is a valuable tool for people with diabetes to improve their self-management skills. Lifestyle changes such as diet and exercise, blood glucose monitoring, online education, peer support, and real-time interaction between patients and healthcare professionals can all be facilitated through social media. Therefore, it is recommended that healthcare professionals use social media-based applications to improve diabetes self-management skills and thereby improve glycemic control. This study will determine the effect of motivational interviewing and social media-based patient monitoring on metabolic control and self-efficacy in adolescents with type 1 diabetes. It will also determine the attitudes of adolescents with T1DM toward their own disease, quality of life, and perceived level of social support.

Вмешательства

  • Другое Motivational interviewing
    This programme has been developed from the literature and structured according to expert opinion. It will consist of a total of 8 online sessions. The duration of the motivational interviewing sessions will be limited to 30-45 minutes, in line with the literature.
  • Другое Social media-based patient monitoring
    Blood glucose results, lowest and highest values, and reasons will be included in the content of the patient follow-up, which will be conducted at intervals on the WhatsApp platform. There will be a total of 10 follow-ups. Although the duration of the written dialog will vary among adolescents, it will be limited to an average of 2-10 minutes.

Первичные конечные точки

  • HbA1c test [Срок оценки: At the beginning of the study (pre-test), 3 months after the pre-test, 6 months after the pre-test]
  • Diabetes Management Self-Efficacy Scale [Срок оценки: At the beginning of the study (pre-test), 6 months after the pre-test]
Вторичные конечные точки (2)
  • Pediatric Quality of Life Inventory (PedsQL) 3.0 Diabetes Module [Срок оценки: At the beginning of the study (pre-test), 6 months after the pre-test]
  • Child Attitude Toward Illness Scale (CATIS) [Срок оценки: At the beginning of the study (pre-test), 6 months after the pre-test]

Критерии участия

Критерии включения

  • 13-18 years old,
  • Diagnosed with type 1 DM at least 6 months ago,
  • HbA1C level >7.0,
  • 3-monthly outpatient visits,
  • Completed basic type 1 DM education and scored high (≥15 points) on the Type 1 Diabetes Knowledge Assessment Form,
  • A WhatsApp user with a smart phone and internet access,
  • Adolescents who can speak and understand Turkish.

Критерии исключения

  • Using an insulin pump,
  • Having a chronic disease other than diabetes,
  • Cognitive, intellectual, hearing, vision, or speech disabilities

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр
  • Istanbul Medeniyet University — Istanbul

Публикации

  • Powell PW, Hilliard ME, Anderson BJ. Motivational interviewing to promote adherence behaviors in pediatric type 1 diabetes. Curr Diab Rep. 2014 Oct;14(10):531. doi: 10.1007/s11892-014-0531-z. PMID 25142716
  • Guo J, Yang J, Wiley J, Ou X, Zhou Z, Whittemore R. Perceived stress and self-efficacy are associated with diabetes self-management among adolescents with type 1 diabetes: A moderated mediation analysis. J Adv Nurs. 2019 Dec;75(12):3544-3553. doi: 10.1111/jan.14179. Epub 2019 Oct 6. PMID 31441523
  • American Diabetes Association. 13. Children and Adolescents: Standards of Medical Care in Diabetes-2021. Diabetes Care. 2021 Jan;44(Suppl 1):S180-S199. doi: 10.2337/dc21-S013. PMID 33298424
  • Al Ksir K, Wood DL, Hasni Y, Sahli J, Quinn M, Ghardallou M. Motivational interviewing to improve self-management in youth with type 1 diabetes: A randomized clinical trial. J Pediatr Nurs. 2022 Sep-Oct;66:e116-e121. doi: 10.1016/j.pedn.2022.05.001. Epub 2022 May 12. PMID 35568602
  • Bakir E, Cavusoglu H, Mengen E. Effects of the Information-Motivation-Behavioral Skills Model on Metabolic Control of Adolescents with Type 1 Diabetes in Turkey: Randomized Controlled Study. J Pediatr Nurs. 2021 May-Jun;58:e19-e27. doi: 10.1016/j.pedn.2020.11.019. Epub 2020 Dec 25. PMID 33371976

Идентификаторы

NCT: NCT06635460 · 26.03.2024/03-27

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗