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Идёт набор NCT06456034

Pilot-testing a Perinatal Palliative Care Intervention Program

Без фазы С лечением Perinatal Palliative Care Life-limiting Fetal Diagnosis Life-limiting Neonatal Diagnosis

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: Perinatal palliative care.
Кому может быть актуально
Состояния в реестре: Perinatal Palliative Care, Life-limiting Fetal Diagnosis, Life-limiting Neonatal Diagnosis. 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
Бельгия
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

Testing a Perinatal Palliative Care Intervention Program Within Standard Perinatal Healthcare: Pilot Testing Protocol

Обзор

The objective of this pilot trial is to implement a new perinatal palliative care intervention program tailored to the Flemish context, which aims to provide care to parents who receive a severe foetal/neonatal diagnosis for their (unborn) child and to their healthcare providers. Additionally, we aim to evaluate the feasibility and preliminary effectiveness by comparing measured variables to the baseline measurement done in the same hospital wards beforehand.

Вмешательства

  • Поведенческое Perinatal palliative care
    Intervention group will receive specialized perinatal palliative care support from moment of severe perinatal diagnosis. This intervention is aimed at 5 major care components, namely 1. Support offered by a fixed perinatal palliative care team, 2. that team has received specialized perinatal palliative care training, 3. care is structured within a new perinatal palliative care approach or pathway, including fixed means of communication with team members, 4. psychological support is structurally

Первичные конечные точки

  • NeoComfort scale [Срок оценки: every four hours (six times per day) during care provision for neonates only]
  • Administered medication and procedures [Срок оценки: during care provision]
  • Contact moments with healthcare providers [Срок оценки: during care provision]
  • Parental Perinatal Grief Scale [Срок оценки: 2 weeks after final contact moment or 6 months post inclusion]
  • Parental Brief-COPE [Срок оценки: 2 weeks after final contact moment or 6 months post inclusion]
  • Parental Satisfaction of Perinatal Palliative Care [Срок оценки: 2 weeks after final contact moment or 6 months post inclusion]
  • Healthcare provider Compassion Satisfaction and Fatigue questionnaire [Срок оценки: 2 weeks after final contact moment or 6 months post inclusion]
  • Healthcare provider Professional Satisfaction with Provided Care [Срок оценки: 2 weeks after final contact moment or 6 months post inclusion]
  • Healthcare provider experienced (psychological) support [Срок оценки: 2 weeks after final contact moment or 6 months post inclusion]
Вторичные конечные точки (2)
  • Parental feasibility and acceptability of pilot [Срок оценки: 2 weeks after final contact moment or 6 months post inclusion]
  • Healthcare provider feasibility and acceptability of pilot [Срок оценки: 2 weeks after final contact moment or 6 months post inclusion]

Критерии участия

Критерии включения

  • Parents:
  • who receive a severe foetal diagnosis for their unborn child and decide to continue the pregnancy after 20 weeks of gestation , or
  • who receive a severe foetal diagnosis for their unborn child after 20 weeks gestation and decide to terminate the pregnancy (with or without feticide) resulting in the stillbirth of their child
  • Parents who receive a severe neonatal diagnosis for their live-born infant in the first week after birth

Additional inclusion criteria for parents:

  • Parents are either Dutch speaking, or are willing to participate with support from a (phone or real life) interpreter, in collaboration with the "Agentschap Integratie \& Inburgering"
  • Parents are older than 18
  • Parents are not suffering from an officially diagnosed psychiatric disorder prior to receiving the severe diagnosis of their child
  • Parents are deemed (emotionally) approachable for the current study by the treating physician

For each family included in the pilot study, the physicians and nurses/midwives who will be/are most closely involved in the care of the infant and the parents will also be asked to participate. If healthcare providers refuse to provide informed consent to participate in the study, their data will be deemed as missing for that case (parental outcomes are considered as the primary outcome measures).

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Бельгия · 2 центра
  • UZ Brussels — Brussels
  • UZ Gent — Ghent

Идентификаторы

NCT: NCT06456034 · PPC-pilot

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗