Integrative Therapy of Chronic Diseases — InteChron  

Chronic Disease Clinical Trial

Official title: A Prospective Observational Study in the Context of an Internal Medicine Clinic for Naturopathy and Integrative Medicine

Status Recruiting

Clinical Trial Summary

The observational study aims to investigate the extent to which a two-week stay in an internal medicine clinic for integrative medicine and naturopathy results in an improvement of complaints, impairments, quality of life, anxiety/depressiveness, stress perception and well-being in chronic gastroenterological patients and chronic rheumatological/pain patients. In addition, previous experiences with complementary naturopathic procedures, expectations of treatment, perceived benefits and implementation of instructed techniques and procedures in everyday life will be investigated.

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.

Clinical Trial Description

This prospective uncontrolled observational study will include a minimum of 600 patients over six months. In the evaluation of the day clinic, the goal is at least 300 (up to approx. 600) patients. Primary outcome is general quality of life (SF-12). Secondary outcomes are anxiety and depression (HADS), well-being/flourishing (Flourishing), stress perception (PSS-10), and disease activity and disease-specific quality of life. In chronic gastroenterological patients, a distinction is made between patients suffering from irritable bowel syndrome (IBS-SSS + IBS-QOL), ulcerative colitis modifed MAYO Score + IBDQ) and Crohn's disease (HBI+ IBDQ). MAYO score: The partial MAYO score is used in this study. This contains only the non-invasive components of the full MAYO score, endoscopic findings are not considered. For chronic rheumatologic/pain patients, a distinction is made between pain patients in general (PDI), rheumatism (DAS-28, RAID), and fibromyalgia syndrome (Fibromyalgia Symptom Questionnaire, PHQ-15, PHQ-4, FIQ). 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.

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. ;

Related Conditions & MeSH terms

• Chronic Disease

• NCT number: NCT04927403
• Study type: Observational
• Source: Universität Duisburg-Essen
• Contact: Jost Langhorst, Prof.
• Phone: 0049951-503-11251
• Email: jost.langhorst@sozialstiftung-bamberg.de
• Status: Recruiting
• Start date: January 4, 2021
• Completion date: December 31, 2024