Меню
Набор по приглашению NCT06679595

Transmural Care for Chronically Ill Children: Scientific Guidance and Evaluation of Pilot Projects

— Наблюдательное Chronic Diseases in Children Chronic Diseases in Adolescence Health Personnel Parents

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: Pilot project paediatric transmural care.
Кому может быть актуально
Состояния в реестре: Chronic Diseases in Children, Chronic Diseases in Adolescence, Health Personnel, Parents. Базовые параметры: Без ограничений · 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
Бельгия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

The goal of this Realist Evaluation is to evaluate the implementation of pilot projects for transmural care in chronically ill children. The main question it aims to answer is: To what extent and how do the pilot projects for transmural care for chronically ill children provide an answer to the quintuple aim? Participants will * Complete questionnaires at three timepoints * Participate in focus group interviews

Подробное описание

Introduction Chronic diseases have been increasing over the past few years, including in children. The chronic condition affects their daily functioning and quality of life and leads to frequent hospital admissions. To avoid unneccessary hospital admissions and to offer alternative and innovative forms of care, the Belgian Federal Public Service of Public Health, Food Chain Safety and Environment selected five pilot projects for transmural care for chronically ill children. This study was designed to evaluate these projects.

Methods and design The overall approach is a two-year longitudinal prospective Realist Evaluation using a mixed-methods design.

The quantitative strand, using routine data and questionnaires, will examine whether data from children, parents/legal guardians and healthcare professionals involved in a pilot project for paediatric transmural care comply with the quintuple aim outcomes.

The qualitative strand will be used (1) to evaluate the structure of the interventions, (2) for process evaluation and context analysis, and (3) to gather more in-depth information. This includes document analysis (including logbooks), focus groups with children, parents/legal guardians and healthcare professionals, and non-participatory observations.

Ethical Informed consent is required prior to inclusion in the evaluation study. Informed assent is requested from children older than 12 years. For this study, advice is asked from the Research Ethics Committee of Ghent University Hospital

Вмешательства

  • Другое Pilot project paediatric transmural care
    The implementation of pilot projects for transmural care for chronically ill children

Первичные конечные точки

  • Quality of Life [Срок оценки: Baseline, 6 months and through study completion, up to 18 months maximum.]
  • Parental Quality of Life [Срок оценки: Baseline, 6 months and through study completion, up to 18 months maximum.]
  • Caregiver burden [Срок оценки: Baseline, 6 months and through study completion, up to 18 months maximum.]
  • Diagnosis [Срок оценки: Through study completion, up to 18 months maximum.]
  • Length of stay in the hospital [Срок оценки: Through study completion, up to 18 months maximum.]
  • Length of stay in transmural care [Срок оценки: Through study completion, up to 18 months maximum.]
  • Transmural care at school [Срок оценки: Through study completion, up to 18 months maximum.]
  • Adverse events [Срок оценки: Continuous data collection, until study completion (18 months)]
  • Patient experience [Срок оценки: Baseline, 6 months and through study completion, up to 18 months maximum.]
  • Parental Empowerment [Срок оценки: Baseline, 6 months and through study completion, up to 18 months maximum.]

Критерии участия

Критерии включения

  • Children: any child up to the age of 18 participating in a pilot project for paediatric transmural care.
  • Parent/Legal guardian: any parent or legal guardian of a child participating in a pilot project for paediatric transmural care
  • Healthcare professionals: any healthcare professional with patient contact involved within a pilot project for paediatric transmural care
  • Coordinators: all study and care coordinators involved within a pilot project for paediatric transmural care

Критерии исключения

  • No signed informed consent form available

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Бельгия · 11 центров
  • Hôpital universitaire des enfants Reine Fabiola — Brussels
  • Cliniques Universitaires Saint-Luc — Brussels
  • Institut de Pathologie et de Génétique Charleroi — Charleroi
  • University Hospital Antwerp — Edegem
  • Universitair Ziekenhuis Gent — Ghent
  • Universitair Ziekenhuis Brussel — Jette
  • Centre Hospitalier Jolimont-Lobbes — La Louvière
  • Universitaire Ziekenhuizen Leuven — Leuven
  • … и ещё 3 центра

Публикации

  • Dequeker S, Vanderwee K, Van Daele S, Duprez V; PETRACA Study Group. Realist evaluation of Belgian pilot projects for paediatric transmural care: protocol for a mixed methods study. BMJ Open. 2025 Jun 25;15(6):e102152. doi: 10.1136/bmjopen-2025-102152. PMID 40562551

Идентификаторы

NCT: NCT06679595 · B670204000193

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗