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.
Study Type
OBSERVATIONAL
Enrollment
2,500
This multicenter, prospective, uncontrolled observational study is evaluating the effects and safety of inpatient TCIM therapy (German: naturheilkundliche Komplextherapie) at three German clinics: Immanuel Hospital Berlin, Klinikum Bamberg, and Evangelical Clinics Essen-Mitte. This therapy, reimbursed by statutory health insurance under certain conditions, combines evidence-informed TCIM approaches such as hyperthermia, exercise therapy, phytotherapy, and dietary interventions including fasting i.a.
Sozialstiftung Bamberg, Klinikum Bamberg
Bamberg, Germany
RECRUITINGCharité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus, Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie, Charité - Universitätsmedizin Berlin
Berlin, Germany
RECRUITINGKlinik für Naturheilkunde und Integrative Medizin, KEM
Essen, Germany
RECRUITINGShort Form Health Survey - 12 Items (SF-12)
0-100, higher scores indicate better health status.
Time frame: Baseline, 3 months
Short Form Health Survey - 12 Items (SF-12)
0-100, higher scores indicate better health status.
Time frame: Baseline, up to 14 days, 6 months, 12 months
EuroQol 5-Dimension 5-Level
0 (worst) to 1 (best), higher scores indicate better health-related quality of life.
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
Food Frequency List
Descriptive measure; not scored on a numeric scale.
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
International Physical Activity Questionnaire - Short Form
MET-min/week (variable), higher scores indicate higher physical activity levels.
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
Hospital Anxiety and Depression Scale
0-21 per subscale (Anxiety and Depression), higher scores indicate more severe symptoms.
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
Work Productivity and Activity Impairment Questionnaire
0%-100%, higher scores indicate greater impairment (i.e., worse outcome).
Time frame: Baseline, 3 months, 6 months, 12 months
Perceived Stress Scale - 4
0-16, higher scores indicate higher perceived stress.
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
Main complaint
Visual Analog Scale (0-100, higher scores mean a worse outcome)
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
Fibromyalgia Impact Questionnaire
0-100, higher scores indicate greater impact of fibromyalgia (worse outcome).
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
Rheumatoid Arthritis Disease Activity Index
0-10, higher scores indicate greater disease activity (worse outcome).
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
Bath Ankylosing Spondylitis Disease Activity Index
0-10, higher scores indicate more active disease (worse outcome).
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
Bath Ankylosing Spondylitis Functional Index
0-10, higher scores indicate more functional limitation (worse outcome).
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
Western Ontario and McMaster Universities Osteoarthritis Index
0-100, higher scores indicate greater pain/stiffness/disability (worse outcome).
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
Irritable Bowel Syndrome Symptom Severity Score
0-500, higher scores indicate more severe IBS symptoms (worse outcome).
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
Short Inflammatory Bowel Disease Questionnaire
10-70, higher scores indicate better quality of life.
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
Pain Disability Index
0-70, higher scores indicate greater disability (worse outcome).
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
Roland Morris Disability Questionnaire
0-24, higher scores indicate more severe disability (worse outcome).
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
Maslach Burnout Inventory
Variable by subscale (Emotional Exhaustion: 0-54, Depersonalization: 0-30, Personal Accomplishment: 0-48) Higher scores on EE/DP = worse outcome; higher PA = better outcome.
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
Beck Depression Inventory-II
0-63, higher scores indicate more severe depressive symptoms (worse outcome).
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
Diabetes Distress Scale - 2
1-6, higher scores indicate greater emotional distress related to diabetes (worse outcome).
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
Dermatology Life Quality Index
0-30, higher scores indicate greater impact on quality of life (worse outcome).
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
Functional Assessment of Cancer Therapy - General
0-108, higher scores indicate better quality of life.
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
Use of the healthcare system
Descriptive data (e.g., number of visits); not a scored scale.
Time frame: Baseline,12 months
Expectations regarding inpatient TCIM treatment
5-point Likert scale, 1-5. Higher scores indicate stronger or more positive expectations.
Time frame: Baseline
Chalder Fatigue Scale
0-33, higher scores mean a worse outcome
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
Somatic Symptom Scale
0-32, higher scores mean a worse outcome
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
Body weight [kg]
Time frame: Baseline, up to 14 days
Height [in cm]
Time frame: Baseline
BMI [kg/m2]
Time frame: Baseline, up to 14 days
Systolic blood pressure [mmHg], diastolic blood pressure [mmHg]
Time frame: Baseline, up to 14 days
Waist circumference [in cm]
Time frame: Baseline, up to 14 days
Triglycerides [mg/dl]
Time frame: Baseline, up to 14 days
Total cholesterol [mg/dl]
Time frame: Baseline, up to 14 days
HDL [mg/dl]
Time frame: Baseline, up to 14 days
LDL [mg/dl]
Time frame: Baseline, up to 14 days
Glucose [mg/dl]
Time frame: Baseline, up to 14 days
Uric acid [μmol/L]
Time frame: Baseline, up to 14 days
Creatinine [mg/dl]
Time frame: Baseline, up to 14 days
CRP [mg/l]
Time frame: Baseline, up to 14 days
GPT [U/l]
Time frame: Baseline, up to 14 days
HbA1c [mmol/mol]
Time frame: Baseline, up to 14 days
HbA1c [%]
Time frame: Baseline, up to 14 days
Headache Impact Test (HIT-6)
36-78. A higher value indicates a greater impairment due to headaches.
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
Integrity of the duodenal intestinal barrier analyzed by confocal laser endomicroscopy (CLE)
The integrity of the intestinal barrier is tested via CLE during routine esophagogastro-duodenoscopy to detect primary or secondary (food-induced) barrier defects. By CLE, the intestinal mucosa and the epithelial lining can be analyzed in vivo with a 1000 x magnification. An intestinal barrier defect can be detected by the leakage of a contrast agent (fluorescein) from the blood vessels through the intestinal epithelial spaces into the intestinal cavity and the shedding of epithelial cells.
Time frame: Baseline, within 3 to 12 months
Result of the esophagogastro-duodenoscopy
Participants undergo an esophagogastro- duodenoscopy with CLE when clinically indicated as part of their inpatient care. Thereby, the inflammatory status and the intestinal barrier is routinely analyzed.
Time frame: Baseline, within 3 to 12 months
Histopathological analysis of duodenal biopsies
Intestinal biopsies, which are routinely taken during esophagogastroduodenoscopy, are processed for histopathological analysis of the mucosal and epithelial structure as well as of the immune cell compartment and to rule out inflammatory processes or intestinal infections.
Time frame: Baseline, within 3 to 12 months
Immunohistochemical analysis of duodenal biopsies
Intestinal biopsies, which are routinely taken during esophagogastroduodenoscopy, are stained using immunohistochemistry and examined for the expression of specific marker proteins (e.g. CD3, eosinophils, Occludin, Claudins).
Time frame: Baseline, within 3 to 12 months
IgE antibody titers
IgE screening of antibodies against typical food allergens (egg white, soy, milk, yeast, wheat) in the serum
Time frame: Baseline, within 3 to 12 months
Analysis of fecal biomarkers, digestive parameters, intestinal flora
The concentrations of different fecal biomarkers are analyzed in stool samples: Calprotectin, Lactoferrin, PMN-Elastase, EDN, Zonulin, Alpha-1-Antitrypsin, Beta-Defensin. Furthermore, digestive parameters such as digestion residues and the intestinal flora are determined.
Time frame: Baseline, within 3 to 12 months
Result of hydrogen breath tests
Lactose, fructose, and sorbitol intolerance is tested via hydrogen breath test
Time frame: Baseline, within 3 to 12 months
Holger Cramer, Prof. Dr.
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