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Набор по приглашению NCT07377266

The Impact of Changing to a New Child- and Family-centered Outpatient Diabetes Clinic Focusing on Early Involvement of the Child With Diabetes, Training in Calmness Around Diabetes Management, Healthy Lifestyle, and Creating Peer-to-peer Networks

Без фазы С лечением Diabetes Quality of Life Children

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: Group consultations and peer-to-peer learning, Standard Care (in control arm).
Кому может быть актуально
Состояния в реестре: Diabetes, Quality of Life, Children. Базовые параметры: 3 лет — 10 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
Дания
Следующий шаг
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Обзор

The goal of StenoChild is to strengthen the treatment of children under 10 years old with diabetes through a multi-component approach. This includes play-based methods, a focus on nutrition and mental health, and peer-to-peer programs that facilitate parental support and learning. The project has both a clinical and organizational dimension, as it aims to improve diabetes care and change practices and task organization at Steno Diabetes Center Copenhagen, SDCC.

Подробное описание

The investigators encourage families to engage in eating, exercising, playing, and storytelling together, leveraging children's natural inclination to learn through play. This approach allows healthcare providers (HCPs) and parents to gain insights into the child's perspective, improving communication.

The hypotheses are i) improved calmness during diabetes-related tasks with potential painful procedures such as shift of insulin infusions set and sensor will ease diabetes management and reduce parental distress; ii) improved structure and calmness around meals will ease diabetes management, reflected in interaction with insulin pumps; iii) the group and play-based approach will lead to healthier lifestyle changes compared to usual care.

Вмешательства

  • Поведенческое Group consultations and peer-to-peer learning
    The intervention introduces strategies to promote structured meals, calmness, and balanced diabetes self-management using play and storytelling learning strategies. Families participate in interactive modules in small groups (\~6-8 families), covering topics like "Meal Calmness" and "Calm Mind" four times during a year (every third month). Parents learn practical techniques to reduce conflict and improve dialogue around diabetes management. Children under 7 receive play-based sessions; those 7
  • Другое Standard Care (in control arm)
    The control group receives standard care, with the intervention offered later in a waitlist design. Clinical data as well as questionnaires will be collected at baseline and again after one year.

Первичные конечные точки

  • Parental diabetes-related quality of life (T1DAL) [Срок оценки: From baseline to study end after one year]
  • Children's perception of clinical visits (MyHospitalVoice) [Срок оценки: From baseline to study end after one year]
Вторичные конечные точки (12)
  • Change in glycemic outcomes by CGM-derived metrics [Срок оценки: From baseline to study end after one year]
  • Change in glycemic outcomes measured by HbA1c [Срок оценки: From baseline to study end after one year]
  • Change in total daily dose of insulin per kg [Срок оценки: From baseline to study end after one year]
  • Change in the number of boluses registered per day [Срок оценки: From baseline to study end after one year]
  • Change in timing of boluses [Срок оценки: From baseline to study end after one year]
  • Change in carbohydrates/kg entered per day [Срок оценки: From baseline to study end after one year]
  • Change in infusion set wear-time [Срок оценки: From baseline to study end after one year]
  • Change in time in automated insulin delivery mode (AID) on the insulin pump system. [Срок оценки: From baseline to study end after one year]
  • Change in conflicts and problems with procedures [Срок оценки: From baseline to study end after one year]
  • Change in parental fear of hypoglycemia [Срок оценки: From baseline to study end after one year]
  • Change in BMI z-scores [Срок оценки: From baseline to study end after one year]
  • Participation in planned modules [Срок оценки: From baseline to study end after one year]

Критерии участия

Inclusion of children and their families

Критерии включения

  • Age 3-10 years
  • Followed at Steno Diabetes Center Copenhagen

Критерии исключения

  • Severe psychiatric disease
  • Language barriers (Children not speaking Danish, Parents not speaking Danish or English)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Последовательный дизайн
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Дания · 1 центр
  • Steno Diabetes Center Copenhagen — Herlev

Идентификаторы

NCT: NCT07377266 · H-25016032 · p-2024-17600

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗