Chronic Disease
Conditions
Brief summary
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.
Interventions
OTHERInpatient TCIM therapy
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.
Sponsors
Universität Tübingen
Universität Duisburg-Essen
Sozialstiftung Bamberg
Charite University, Berlin, Germany
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Beginning (first 24 hours) inpatient TCIM treatment at Immanuel Hospital Berlin, Bamberg Hospital, or Evangelische Kliniken Essen-Mitte * Written consent form
Exclusion criteria
* Insufficient language skills * Dementia or other severely impairing cognitive disorders * Pregnancy or breastfeeding * Participation in a clinical study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short Form Health Survey - 12 Items (SF-12) | Baseline, 3 months | 0-100, higher scores indicate better health status. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Integrity of the duodenal intestinal barrier analyzed by confocal laser endomicroscopy (CLE) | Baseline, within 3 to 12 months | 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. |
| 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 | 36-78. A higher value indicates a greater impairment due to headaches. |
| Result of the esophagogastro-duodenoscopy | Baseline, within 3 to 12 months | 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. |
| Histopathological analysis of duodenal biopsies | Baseline, within 3 to 12 months | 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. |
| Immunohistochemical analysis of duodenal biopsies | Baseline, within 3 to 12 months | 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). |
| IgE antibody titers | Baseline, within 3 to 12 months | IgE screening of antibodies against typical food allergens (egg white, soy, milk, yeast, wheat) in the serum |
| Analysis of fecal biomarkers, digestive parameters, intestinal flora | Baseline, within 3 to 12 months | 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. |
| Result of hydrogen breath tests | Baseline, within 3 to 12 months | Lactose, fructose, and sorbitol intolerance is tested via hydrogen breath test |
| Short Form Health Survey - 12 Items (SF-12) | Baseline, up to 14 days, 6 months, 12 months | 0-100, higher scores indicate better health status. |
| EuroQol 5-Dimension 5-Level | Baseline, up to 14 days, 3 months, 6 months, 12 months | 0 (worst) to 1 (best), higher scores indicate better health-related quality of life. |
| Food Frequency List | Baseline, up to 14 days, 3 months, 6 months, 12 months | Descriptive measure; not scored on a numeric scale. |
| International Physical Activity Questionnaire - Short Form | Baseline, up to 14 days, 3 months, 6 months, 12 months | MET-min/week (variable), higher scores indicate higher physical activity levels. |
| Hospital Anxiety and Depression Scale | Baseline, up to 14 days, 3 months, 6 months, 12 months | 0-21 per subscale (Anxiety and Depression), higher scores indicate more severe symptoms. |
| Work Productivity and Activity Impairment Questionnaire | Baseline, 3 months, 6 months, 12 months | 0%-100%, higher scores indicate greater impairment (i.e., worse outcome). |
| Perceived Stress Scale - 4 | Baseline, up to 14 days, 3 months, 6 months, 12 months | 0-16, higher scores indicate higher perceived stress. |
| Main complaint | Baseline, up to 14 days, 3 months, 6 months, 12 months | Visual Analog Scale (0-100, higher scores mean a worse outcome) |
| Fibromyalgia Impact Questionnaire | Baseline, up to 14 days, 3 months, 6 months, 12 months | 0-100, higher scores indicate greater impact of fibromyalgia (worse outcome). |
| Rheumatoid Arthritis Disease Activity Index | Baseline, up to 14 days, 3 months, 6 months, 12 months | 0-10, higher scores indicate greater disease activity (worse outcome). |
| Bath Ankylosing Spondylitis Disease Activity Index | Baseline, up to 14 days, 3 months, 6 months, 12 months | 0-10, higher scores indicate more active disease (worse outcome). |
| Bath Ankylosing Spondylitis Functional Index | Baseline, up to 14 days, 3 months, 6 months, 12 months | 0-10, higher scores indicate more functional limitation (worse outcome). |
| Western Ontario and McMaster Universities Osteoarthritis Index | Baseline, up to 14 days, 3 months, 6 months, 12 months | 0-100, higher scores indicate greater pain/stiffness/disability (worse outcome). |
| Irritable Bowel Syndrome Symptom Severity Score | Baseline, up to 14 days, 3 months, 6 months, 12 months | 0-500, higher scores indicate more severe IBS symptoms (worse outcome). |
| Short Inflammatory Bowel Disease Questionnaire | Baseline, up to 14 days, 3 months, 6 months, 12 months | 10-70, higher scores indicate better quality of life. |
| Pain Disability Index | Baseline, up to 14 days, 3 months, 6 months, 12 months | 0-70, higher scores indicate greater disability (worse outcome). |
| Roland Morris Disability Questionnaire | Baseline, up to 14 days, 3 months, 6 months, 12 months | 0-24, higher scores indicate more severe disability (worse outcome). |
| Maslach Burnout Inventory | Baseline, up to 14 days, 3 months, 6 months, 12 months | 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. |
| Beck Depression Inventory-II | Baseline, up to 14 days, 3 months, 6 months, 12 months | 0-63, higher scores indicate more severe depressive symptoms (worse outcome). |
| Diabetes Distress Scale - 2 | Baseline, up to 14 days, 3 months, 6 months, 12 months | 1-6, higher scores indicate greater emotional distress related to diabetes (worse outcome). |
| Dermatology Life Quality Index | Baseline, up to 14 days, 3 months, 6 months, 12 months | 0-30, higher scores indicate greater impact on quality of life (worse outcome). |
| Functional Assessment of Cancer Therapy - General | Baseline, up to 14 days, 3 months, 6 months, 12 months | 0-108, higher scores indicate better quality of life. |
| Use of the healthcare system | Baseline,12 months | Descriptive data (e.g., number of visits); not a scored scale. |
| Expectations regarding inpatient TCIM treatment | Baseline | 5-point Likert scale, 1-5. Higher scores indicate stronger or more positive expectations. |
| Chalder Fatigue Scale | Baseline, up to 14 days, 3 months, 6 months, 12 months | 0-33, higher scores mean a worse outcome |
| Somatic Symptom Scale | Baseline, up to 14 days, 3 months, 6 months, 12 months | 0-32, higher scores mean a worse outcome |
| 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 | — |
Other
| Measure | Time frame |
|---|---|
| Number of participants taking antidepressive medication | Baseline, up to 14 days, 3 months, 6 months, 12 months |
| Number of participants taking anxiolytics | Baseline, up to 14 days, 3 months, 6 months, 12 months |
| Number of participants taking migraine medication | Baseline, up to 14 days, 3 months, 6 months, 12 months |
| Number of participants taking antihypertensive medication | Baseline, up to 14 days, 3 months, 6 months, 12 months |
| Number of participants taking lipid-lowering medication | Baseline, up to 14 days, 3 months, 6 months, 12 months |
| Number of participants taking corticosteroids | Baseline, up to 14 days, 3 months, 6 months, 12 months |
| Number of participants taking antidiabetic medication | Baseline, up to 14 days, 3 months, 6 months, 12 months |
| Number of participants taking biologics | Baseline, up to 14 days, 3 months, 6 months, 12 months |
| Number of participants taking immunosuppressants | Baseline, up to 14 days, 3 months, 6 months, 12 months |
| Adverse events | Baseline, up to 14 days, 3 months, 6 months, 12 months |
| Number of participants taking pain medication | Baseline, up to 14 days, 3 months, 6 months, 12 months |
| Number of participants with diagnoses | Baseline, up to 14 days, 3 months, 6 months, 12 months |
Countries
Germany
Contacts
Primary ContactMichael Jeitler, PD Dr.
Backup ContactHolger Cramer, Prof. Dr.
Outcome results
None listed