E-health-supported Diagnostic and Intervention in Preterm Born Children and Their Families
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: Intervention Group (APP), Treatment as usual-Group (TAU).
- Кому может быть актуально
- Состояния в реестре: Preterm Birth. Базовые параметры: 28 Weeks — 34 Weeks · 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
- Германия
- 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
E-health-supported Recording of Psychological and Somatic Problems, Risk and Resilience Factors of Premature Born Infants and Their Families and Individualized, Interdisciplinary Stepped-care Approach
Обзор
The app-based diagnostic and support approach with a focus on mental and somatic symptoms is intended to strengthen the resilience of premature born children and families and to identify risk and resilience factors.The overall objective of the study is to improve the post-inpatient care of families with premature born children. The procedure is evaluated by a two-arm design with an experimental group and a TAU group.
Подробное описание
The project aims to conduct a longitudinal study of premature babies and their parents from the time of hospital discharge in order to identify predictive factors for their psychological and physical outcomes and to provide individualized interdisciplinary diagnostic and treatment. The project helps to identify risk and protective factors and also takes a closer look at the interplay between the mind and body. This care approach is supported by an app that records symptoms and needs and also allows contact with the study team. The app also provides psychoeducational materials. The study was developed in collaboration with affected families and experts from the aftercare team. The concept will be evaluated by comparing the treatment group with a TAU group and by conducting measurements after hospital discharge, after 4 months after estimated date of birth, and again after 2 months, as well as through focus groups with study participants.
Вмешательства
- Другое Intervention Group (APP)
Combination of app-based information and diagnostic screening for parents of premature babies. - Другое Treatment as usual-Group (TAU)
No intervention. Treatment in the form of usual aftercare service is possible.
Первичные конечные точки
- Questionnaire on satisfaction, feasibility, needs (FB-NB) [Срок оценки: At month 4 (post-teatment, T1) and month 7 (follow-up, T2)]
- Parent Stress Inventory (EBI) [Срок оценки: At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).]
- Crying, Feeding and Sleeping Questionnaire (SFS) [Срок оценки: At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).]
Вторичные конечные точки (12)
- Demographic data [Срок оценки: At baseline (before treatment, T0).]
- Brief Symptom Inventory (BSI) [Срок оценки: At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).]
- Brief Infant Sleep Questionnaire (BISQ) [Срок оценки: At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).]
- Edinburgh Postnatal Depression Scale (EPDS) [Срок оценки: At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).]
- Couple Conflict Questionnaire (PFB-K) [Срок оценки: At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).]
- Parent-Child Relationship Questionnaire (PBQ) [Срок оценки: At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).]
- Ulm Quality of Life Inventory for Parents (ULQIE) [Срок оценки: At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).]
- Ages & Stages Questionnaire®: Third Edition (ASQ-3) [Срок оценки: At month 4 (post-teatment, T1) and month 7 (follow-up, T2).]
- Focus groups [Срок оценки: At baseline (before treatment, T0), after month 7 (follow-up, T1).]
- App-questions [Срок оценки: Every 14 days over a period of 4 months (baseline, T0 - post-treatment, T1).]
- Questionnaire on health economics (HCU-Q) [Срок оценки: At month 4 (post-teatment, T1) and month 7 (follow-up, T2).]
- Self-efficacy questionnaire (SWE) [Срок оценки: At baseline (before treatment, T0), at month 4 (post-teatment, T1).]
Критерии участия
Критерии включения
- Premature babies born at the UKT,
- Gestational age 28-34 weeks,
- Mother: age ≥ 18 years,
- agreement to participate in this study and signing of a consent form,
- sufficient knowledge of German,
- internet access
Критерии исключения
- Premature babies < 28th or >34th week of pregnancy,
- at least one of the children has serious diseases of the nervous system or obvious symptoms of a nervous disease,
- at least one of the children has serious congenital diseases or suffers from malformations,
- Mother: Lack of access to a smartphone/tablet,
- no internet access,
- insufficient knowledge of German
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Профилактика
Центры проведения
Германия · 1 центр
- University Hospital Tuebingen — Tübingen
Идентификаторы
NCT: NCT06939192 · 652/2023BO2