NCT06759402招募中不适用
Family-based Telemedicine Vs. Inpatient Anorexia Nervosa Treatment (FIAT)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in %mBMI
研究概览
简要总结
The FIAT study is funded by the Innovationsfonds of the German Ministry of Health via the DLR Project Management Agency. The study will be conducted in up to 21 hospitals across Germany and in collaboration with 10 German public health insurance companies. The primary aim of this study is to compare Family-Based Treatment delivered via telehealth (FBT) with inpatient multimodal therapy (IMT) with respect to treatment outcomes and health economic data. The results of the study will serve as a basis for the decision on the inclusion of FBT in the German S3 guidelines and the future reimbursement of FBT by public health insurances in Germany.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •restrictive and bulimic subtypes of anorexia nervosa (ICD-10: F50.00; F50.01)
- •inpatient treatment indication according to S3 guideline
- •weight <
- •BMI-percentile or
- •weight <
- •percentile and psychiatric comorbidity/rapid weight loss/lack of weight gain during outpatient treatment over last three month
- •planned inpatient treatment
- •insured with one of the participating health insurance companies
- •stable internet connection
排除标准
- •weight <67%mBMI
- •acute self harm or danger to others
- •acute psychosis or suicidal tendencies
- •current substance abuse
- •child abuse or domestic violence in the family
- •insured with other health insurance company
- •judicial placement order for inpatient treatment
- •known, currently existing child protection problems or proceedings by the family court
研究组 & 干预措施
FBT
Experimental
family-based therapy as a stepped care model using telemedicine
干预措施: Family based treatment (Behavioral)
IMT
Active Comparator
inpatient multimodal therapy
干预措施: Inpatient multimodal therapy (Behavioral)
结局指标
主要结局
Change in %mBMI
时间窗: 12 months
The %mBMI is calcualted based on bodyweight and height, measured by the study team. Change is the difference between the baseline and 12 month %mBMI.
次要结局
- Change in eating disorder quality of life(At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.)
- Change in quality of life(6 months after baseline and 12 months after baseline.)
- Emotional and financial burden on the legal guardians(At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.)
- Financial burden on the legal guardians(6 months after baseline and 12 months after baseline.)
- Utilization and costs of healthcare services(6 months after baseline and 12 months after baseline.)
- Specific psychopathology for anorexia nervosa(At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.)
- Compulsive exercise(At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.)
- Depression(At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.)
- Occurrence of adverse events(At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.)
- Menstrual status(At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.)
- Medication(At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.)
- Motivation for change(At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.)
- Insight into illness(At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.)
- Satisfaction with treatment for patients(At the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months))
- Satisfaction with treatment for parents (Likert scale items)(At the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months))
- Satisfaction with treatment for parents (Free-text items)(At the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months))
- Suicidality(At the beginning of the study, at the end of treatment (FBT Arm-average: 10 Months; IMT Arm-average: 4 Months; both up to 12 months), 6 months after baseline and 12 months after baseline.)
研究者
Prof. Dr. med Christoph Correll
Clinic Director
Charite University, Berlin, Germany
研究点 (1)
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