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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Questionnaire on satisfaction, feasibility, needs (FB-NB)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 28 Weeks 至 34 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Intervention Group (APP)
The participants in the intervention group will be equipped with an app after inclusion in the study. The app contains specific information for parents with premature babies, a contact form for experts and questions about the child's development every 14 days.
干预措施: Intervention Group (APP) (Other)
Treatment as usual Group (TAU)
Participants in the treatment as usual group do not receive an app after inclusion in the study. They can contact their pediatrician if they have any questions.
干预措施: Treatment as usual-Group (TAU) (Other)
结局指标
主要结局
Questionnaire on satisfaction, feasibility, needs (FB-NB)
时间窗: At month 4 (post-teatment, T1) and month 7 (follow-up, T2)
After completion of the main study phase, the self-constructed questionnaire assesses satisfaction with the study concept and evaluates the feasibility of the study approach. Patients are asked to indicate their satisfaction using a Likert scale and can also note down any additional or modification requests in free text fields.
Crying, Feeding and Sleeping Questionnaire (SFS)
时间窗: At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).
The questionnaire on regulatory disorders in childhood uses 54 questions to assess early childhood regulatory disorders in relation to crying, eating or sleeping. The response format is generally a 4-point scale from not at all to very much.
Parent Stress Inventory (EBI)
时间窗: At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).
The EBI measures the extent of parental stress and contains 48 items that are assigned to 12 subscales. Answering on a Likert scale.
次要结局
- Demographic data(At baseline (before treatment, T0).)
- Ages & Stages Questionnaire®: Third Edition (ASQ-3)(At month 4 (post-teatment, T1) and month 7 (follow-up, T2).)
- Focus groups(At baseline (before treatment, T0), after month 7 (follow-up, T1).)
- Brief Symptom Inventory (BSI)(At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).)
- Parent-Child Relationship Questionnaire (PBQ)(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)(At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).)
- Brief Infant Sleep Questionnaire (BISQ)(At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).)
- Edinburgh Postnatal Depression Scale (EPDS)(At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).)
- Couple Conflict Questionnaire (PFB-K)(At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).)
- Questionnaire on health economics (HCU-Q)(At month 4 (post-teatment, T1) and month 7 (follow-up, T2).)
- App-questions(Every 14 days over a period of 4 months (baseline, T0 - post-treatment, T1).)
- Self-efficacy questionnaire (SWE)(At baseline (before treatment, T0), at month 4 (post-teatment, T1).)
- On-site clinical examination: Assessment of height in cm(At baseline (before treatment, T0), at month 4 (post-teatment, T1).)
- On-site clinical examination: Assessment of weight in g(At baseline (before treatment, T0), at month 4 (post-teatment, T1).)
- On-site clinical examination: Assessment of self-reported illnesses of the child(At baseline (before treatment, T0), at month 4 (post-teatment, T1).)
研究者
PD Dr. Annette Conzelmann
Prof. Dr. Annette Conzelmann
University Hospital Tuebingen