Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1000 participants
OBSERVATIONAL
2021-01-04
2024-12-31
Brief Summary
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Since May 2021, patients with Post Covid-19 Syndrome have been treated as inpatients during a stay that usually lasts 14 days. Since January 2022 these patients are evaluated in the substudy "StaPoCo". Since 2022 Post Covid-19 Syndrome day clinic patients were also evaluated.
Sub-Study "Intestinal barrier dysfunction" - Gastroenterological patients who undergo routine gastroscopy and/or colonoscopy with confocal laser endomicroscopy (cLE) and tissue biopsies at the beginning of their inpatient stay are explicitly examined for the presence of a barrier disorder.
Since May 2021 patients can take part in the day clinic programme one day weekly for ten or eleven weeks. In this programme also patients with oncological disorders take part.
Starting in the fall of 2022, the integrative medicine/naturopathic day clinics at the Immanuel Hospital in Berlin and the Ev. Kliniken Essen-Mitte will be included in the evaluation.
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Detailed Description
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Substudy "StaPoCo" - In the case of post-Covid-19 disease, the Brief Pain Inventory (BPI), the MFI-20 questionnaire, the EQ-5D-5L are evaluated in addition to the modified baseline questionnaire, which is based on socio-demographic data, Covid-19 history. The survey of patients takes place at admission, discharge and after 6 months. Post-COVID-19 autoantibody screening (1xserum), as well as T-cell activation assay (Elispot) for the identification of potentially reactivated latent pathogens, such as EBV, CMV, VZV, TB and NTM (1xCPDA) (by biovis Diagnostics), which are scientifically discussed as potential causes for post-viral fatigue symptomatology, should be performed as part of the routine blood collection at admission (baseline) and discharge for post-COVID-19 inpatient patients.
Sub-Study "Intestinal barrier dysfunction" - Gastroenterological patients who undergo routine gastroscopy and/or colonoscopy with confocal laser endomicroscopy (cLE) and tissue biopsies at the beginning of their inpatient stay are explicitly examined for the presence of a barrier disorder. Patient groups: Crohn's disease (MC), ulcerative colitis (CU), irritable bowel syndrome (IBS). With this sub-study, the barrier disorder (primary or secondary) detected in the context of routine care and the corresponding therapies are to be observed in the course. At timepoints week 0 and after the end therapy (week 12-24) following parameters were assessed: the serum marker I-FABP and tissue samples for immunohistochemistry and gene expression analyzes, as well as the determination of food allergen-specific IgG/igG4 antibodies.
In the day clinic program also patients with oncological diseases (questionnaires: QLQ-C30 and FBK-R23) will be asked. In some day clinic groups a group discussion of about 45-60 minutes is to take place at the end of the treatment. Participants of the respective course who agree to take part in the group discussion, will be asked to make additional comments on the attended programme by means of standardised questionnaires.
Some participants (20) are also asked to take part in an individual telephone interview 6 months after completion of the programme. In this interview, the course of the patient's illness and the effects of participation in the day clinic on the illness and the patient's lifestyle in the past months are to be determined in more detail. A special focus is on the independent continuation of health-promoting measures after the end of the day clinic participation and the evaluation of supporting factors and obstacles in the implementation of the learned contents and techniques of the programme. The patients are selected on the basis of socio-demographic and clinical characteristics with the aim of obtaining a sample that is as heterogeneous as possible. The survey of patients takes place at the beginning of the day clinic, at the end of the programme (week 10 or 11) and after 6 months after the treatment.
The German Pain Questionnaire/ Severity Grading according to von Korff is applied to each of the three diseases. In addition, sociodemographics (age, gender, educational level, employment status, family situation), previous course of the disease, previous experience with/application of complementary medicine and naturopathic procedures, expectations of complementary medicine and naturopathic procedures used in the clinic, assessment and satisfaction with inpatient therapy program and planned and realized application of learned procedures are considered.
Starting in the fall of 2022, the integrative medicine/naturopathic day clinics at the Immanuel Hospital in Berlin and the Ev. Kliniken Essen-Mitte will be included in the evaluation. Since other patient groups are treated in Essen and Berlin (e.g., patients with cardiovascular diseases, chron. Pulmonary diseases, metabolic disorders and skin diseases, etc.), an additional questionnaire package was created for the indication group "Other diseases", in which the disease-specific symptoms are recorded using the MYMOP questionnaire. For the indication group "Rheumatic diseases", a questionnaire (HAQ) was added.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Chronic gastroenterological diseases - inpatient stay and day clinic
Irritable Bowel Syndrome, Crohn's disease, Ulcerative colitis
multimodal integrative naturopathic therapy concept
Use of conventional medicine, naturopathic approaches and complementary medical therapy methods
Chronic Pain patients - inpatient stay and day clinic
Chronic pain syndrome, Rheumatism, Fibromyalgia
multimodal integrative naturopathic therapy concept
Use of conventional medicine, naturopathic approaches and complementary medical therapy methods
Oncological diseases - day clinic
all kinds of oncological diseases
multimodal integrative naturopathic therapy concept
Use of conventional medicine, naturopathic approaches and complementary medical therapy methods
post Covid syndrome - inpatient stay and day clinic
post Covid sydrome
multimodal integrative naturopathic therapy concept
Use of conventional medicine, naturopathic approaches and complementary medical therapy methods
other diseases - day clinic
e.g. patients with cardiovascular diseases, chron. Pulmonary diseases, metabolic disorders and skin diseases, etc.
multimodal integrative naturopathic therapy concept
Use of conventional medicine, naturopathic approaches and complementary medical therapy methods
Interventions
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multimodal integrative naturopathic therapy concept
Use of conventional medicine, naturopathic approaches and complementary medical therapy methods
Eligibility Criteria
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Inclusion Criteria
* signed declaration of consent
Exclusion Criteria
* Expected life expectancy \< 6 months (oncology patients).
18 Years
ALL
No
Sponsors
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Sozialstiftung Bamberg
OTHER
Bavarian State Ministry of Health and Care
OTHER_GOV
Charite University, Berlin, Germany
OTHER
Kliniken Essen-Mitte
OTHER
Universität Duisburg-Essen
OTHER
Responsible Party
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Jost Langhorst
Prof. Dr. med.
Principal Investigators
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Jost Langhorst, Prof.
Role: PRINCIPAL_INVESTIGATOR
Sozialstiftung Bamberg, Klinik für Integrative Medizin und Naturheilkunde
Locations
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Sozialstiftung Bamberg, Klinik für Intergrative Medizin
Bamberg, Bavaria, Germany
Evang. Kliniken Essen-Mitte, Klinik für Naturheilkunde & Integrative Medizin
Essen, , Germany
Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus Berlin, Standort Berlin-Wannsee
Wannsee, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20068
Identifier Type: -
Identifier Source: org_study_id
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