Effects of the Clinical Application of TCIM Procedures During Inpatient Stays in Germany - a Multicenter Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,500
- 试验地点
- 3
- 主要终点
- Short Form Health Survey - 12 Items (SF-12)
研究概览
简要总结
The aim of this healthcare research project is to evaluate the effects of routine inpatient TCIM (Traditional, Complementary and Integrative Medicine) care in Germany. The focus is on the TCIM centers at Immanuel Krankenhaus Berlin, Klinikum Bamberg und Evang. Kliniken Essen-Mitte, where inpatient TCIM therapies are to be systematically evaluated. This form of therapy, which is reimbursed by statutory health insurance providers (under certain conditions), is based on a combination of various evidence-based TCIM approaches. These include hyperthermia, exercise therapy, Mind-Body Medicine, phytotherapy, nutritional therapy, fasting therapy inter alia.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Short Form Health Survey - 12 Items (SF-12)
时间窗: Baseline, 3 months
0-100, higher scores indicate better health status.
次要结局
- Short Form Health Survey - 12 Items (SF-12)(Baseline, up to 14 days, 6 months, 12 months)
- EuroQol 5-Dimension 5-Level(Baseline, up to 14 days, 3 months, 6 months, 12 months)
- Food Frequency List(Baseline, up to 14 days, 3 months, 6 months, 12 months)
- International Physical Activity Questionnaire - Short Form(Baseline, up to 14 days, 3 months, 6 months, 12 months)
- Hospital Anxiety and Depression Scale(Baseline, up to 14 days, 3 months, 6 months, 12 months)
- Work Productivity and Activity Impairment Questionnaire(Baseline, 3 months, 6 months, 12 months)
- Perceived Stress Scale - 4(Baseline, up to 14 days, 3 months, 6 months, 12 months)
- Main complaint(Baseline, up to 14 days, 3 months, 6 months, 12 months)
- Fibromyalgia Impact Questionnaire(Baseline, up to 14 days, 3 months, 6 months, 12 months)
- Rheumatoid Arthritis Disease Activity Index(Baseline, up to 14 days, 3 months, 6 months, 12 months)
- Bath Ankylosing Spondylitis Disease Activity Index(Baseline, up to 14 days, 3 months, 6 months, 12 months)
- Bath Ankylosing Spondylitis Functional Index(Baseline, up to 14 days, 3 months, 6 months, 12 months)
- Western Ontario and McMaster Universities Osteoarthritis Index(Baseline, up to 14 days, 3 months, 6 months, 12 months)
- Irritable Bowel Syndrome Symptom Severity Score(Baseline, up to 14 days, 3 months, 6 months, 12 months)
- Short Inflammatory Bowel Disease Questionnaire(Baseline, up to 14 days, 3 months, 6 months, 12 months)
- Pain Disability Index(Baseline, up to 14 days, 3 months, 6 months, 12 months)
- Roland Morris Disability Questionnaire(Baseline, up to 14 days, 3 months, 6 months, 12 months)
- Maslach Burnout Inventory(Baseline, up to 14 days, 3 months, 6 months, 12 months)
- Beck Depression Inventory-II(Baseline, up to 14 days, 3 months, 6 months, 12 months)
- Diabetes Distress Scale - 2(Baseline, up to 14 days, 3 months, 6 months, 12 months)
- Dermatology Life Quality Index(Baseline, up to 14 days, 3 months, 6 months, 12 months)
- Functional Assessment of Cancer Therapy - General(Baseline, up to 14 days, 3 months, 6 months, 12 months)
- Use of the healthcare system(Baseline,12 months)
- Expectations regarding inpatient TCIM treatment(Baseline)
- Chalder Fatigue Scale(Baseline, up to 14 days, 3 months, 6 months, 12 months)
- Somatic Symptom Scale(Baseline, up to 14 days, 3 months, 6 months, 12 months)
- Body weight [kg](Baseline, up to 14 days)
- Height [in cm](Baseline)
- BMI [kg/m2](Baseline, up to 14 days)
- Systolic blood pressure [mmHg], diastolic blood pressure [mmHg](Baseline, up to 14 days)
- Waist circumference [in cm](Baseline, up to 14 days)
- Triglycerides [mg/dl](Baseline, up to 14 days)
- Total cholesterol [mg/dl](Baseline, up to 14 days)
- HDL [mg/dl](Baseline, up to 14 days)
- LDL [mg/dl](Baseline, up to 14 days)
- Glucose [mg/dl](Baseline, up to 14 days)
- Uric acid [μmol/L](Baseline, up to 14 days)
- Creatinine [mg/dl](Baseline, up to 14 days)
- CRP [mg/l](Baseline, up to 14 days)
- GPT [U/l](Baseline, up to 14 days)
- HbA1c [mmol/mol](Baseline, up to 14 days)
- HbA1c [%](Baseline, up to 14 days)
- Headache Impact Test (HIT-6)(Baseline, up to 14 days, 3 months, 6 months, 12 months)
- Integrity of the duodenal intestinal barrier analyzed by confocal laser endomicroscopy (CLE)(Baseline, within 3 to 12 months)
- Result of the esophagogastro-duodenoscopy(Baseline, within 3 to 12 months)
- Histopathological analysis of duodenal biopsies(Baseline, within 3 to 12 months)
- Immunohistochemical analysis of duodenal biopsies(Baseline, within 3 to 12 months)
- IgE antibody titers(Baseline, within 3 to 12 months)
- Analysis of fecal biomarkers, digestive parameters, intestinal flora(Baseline, within 3 to 12 months)
- Result of hydrogen breath tests(Baseline, within 3 to 12 months)
研究者
Michael Jeitler
Principal Investigator
Charite University, Berlin, Germany
