Clinical trial NCT04927403: Integrative Therapy of Chronic Diseases
Official title: A Prospective Observational Study in the Context of an Internal Medicine Clinic for Naturopathy and Integrative Medicine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Disease
Keywords: irritable bowel syndrome
ulcerative colitis
Crohn's disease
pain patients
rheumatism
fibromyalgia syndrome
integrative medicine
naturopathy
irritable bowel disease
chronic pain syndrome
complementary medicine
post Covid syndrome
oncological diseases
day clinic
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
Collaborators: name: Sozialstiftung Bamberg
name: Bavarian State Ministry of Health and Care
name: Charite University, Berlin, Germany
name: Kliniken Essen-Mitte
First posted: 2021-06-16
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who are admitted to the Clinic for Integrative Medicine and Naturopathy for inpatient treatment and belong to the following patient groups can participate:

chronic gastroenterological patients: irritable bowel syndrome, ulcerative colitis, Crohn's disease chronic pain patients: rheumatism, fibromyalgia syndrome, chronic pain syndrome post Covid-19 syndrome patients: post Covid-19 syndromes oncological patients: all kinds of oncological diseases (only day clinic treatment)

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Patients at least 18 years of age
* signed declaration of consent

Exclusion Criteria:

* Patients who have not reached the age of 18.
* Expected life expectancy \< 6 months (oncology patients).

Primary outcomes:
measure: Generic quality of life
timeFrame: week 0
measure: Generic quality of life
timeFrame: week 2 (inpatient), week 10/11 (day clinic)
measure: Generic quality of life
timeFrame: week 24 (inpatient), week 34/35 (day clinic)
Secondary outcomes:
measure: anxiety and depression
timeFrame: week 0
measure: anxiety and depression
timeFrame: week 2 (inpatient), week 10/11 (day clinic)
measure: anxiety and depression
timeFrame: week 24 (inpatient), week 34/35 (day clinic)
measure: sex
timeFrame: week 0
measure: age
timeFrame: week 0
measure: job
timeFrame: week 0
measure: Educational level
timeFrame: week 0
measure: Expectation of the treatment (questionnaire)
timeFrame: week 0
measure: Use of complementary medicine/natural remedies (questionnaire)
timeFrame: week 0
measure: Course of the disease (questionnaire)
timeFrame: week 0
measure: wellbeing/flourishing
timeFrame: week 0 (inpatient stay)
measure: wellbeing/flourishing
timeFrame: week 2 (inpatient stay)
measure: wellbeing/flourishing
timeFrame: week 24 (inpatient stay)
measure: Perceived stress
timeFrame: week 0
measure: Perceived stress
timeFrame: week 2 (inpatient), week 10/11 (day clinic)
measure: Perceived stress
timeFrame: week 24 (inpatient), week 34/35 (day clinic)
measure: disease activity (irritable bowel syndrome)
timeFrame: week 0
measure: disease activity (irritable bowel syndrome)
timeFrame: week 2 (inpatient), week 10/11 (day clinic)
measure: disease activity (irritable bowel syndrome)
timeFrame: week 24 (inpatient), week 34/35 (day clinic)
measure: diseasespecific quality of life (irritable bowel syndrome)
timeFrame: week 0
measure: diseasespecific quality of life (irritable bowel syndrome)
timeFrame: week 2 (inpatient), week 10/11 (day clinic)
measure: diseasespecific quality of life (irritable bowel syndrome)
timeFrame: week 24 (inpatient), week 34/35 (day clinic)
measure: Partial Mayo Score, disease activity (ulcerative colitis)
timeFrame: week 0
measure: Partial Mayo Score, disease activity (ulcerative colitis)
timeFrame: week 2 (inpatient), week 10/11 (day clinic)
measure: Partial Mayo Score, disease activity (ulcerative colitis)
timeFrame: week 24 (inpatient), week 34/35 (day clinic)
measure: diseasespecific quality of life (ulcerative colitis)
timeFrame: week 0
measure: diseasespecific quality of life (ulcerative colitis)
timeFrame: week 2 (inpatient), week 10/11 (day clinic)
measure: diseasespecific quality of life (ulcerative colitis)
timeFrame: week 24 (inpatient), week 34/35 (day clinic)
measure: disease activity (Crohn's disease)
timeFrame: week 0
measure: disease activity (Crohn's disease)
timeFrame: week 2 (inpatient), week 10/11 (day clinic)
measure: disease activity (Crohn's disease)
timeFrame: week 24 (inpatient), week 34/35 (day clinic)
measure: diseasespecific quality of life (Crohn's disease)
timeFrame: week 0
measure: diseasespecific quality of life (Crohn's disease)
timeFrame: week 2 (inpatient), week 10/11 (day clinic)
measure: diseasespecific quality of life (Crohn's disease)
timeFrame: week 24 (inpatient), week 34/35 (day clinic)
measure: disease activity (pain patients)
timeFrame: week 0
measure: disease activity (pain patients)
timeFrame: week 2 (inpatient), week 10/11 (day clinic)
measure: disease activity (pain patients)
timeFrame: week 24 (inpatient), week 34/35 (day clinic)
measure: diseasespecific quality of life (pain patients)
timeFrame: week 0
measure: diseasespecific quality of life (pain patients)
timeFrame: week 2 (inpatient), week 10/11 (day clinic)
measure: diseasespecific quality of life (pain patients)
timeFrame: week 24 (inpatient), week 34/35 (day clinic)
measure: disease activity (rheumatism)
timeFrame: week 0
measure: disease activity (rheumatism)
timeFrame: week 2 (inpatient), week 10/11 (day clinic)
measure: disease activity (rheumatism)
timeFrame: week 24 (inpatient), week 34/35 (day clinic)
measure: diseasespecific quality of life (rheumatism)
timeFrame: week 0
measure: diseasespecific quality of life (rheumatism)
timeFrame: week 2 (inpatient), week 10/11 (day clinic)
measure: diseasespecific quality of life (rheumatism)
timeFrame: week 24 (inpatient), week 34/35 (day clinic)
measure: disease activity and diseasespecific quality of life (rheumatism)
timeFrame: week 0
measure: disease activity and diseasespecific quality of life (rheumatism)
timeFrame: week 2 (inpatient), week 10/11 (day clinic)
measure: disease activity and diseasespecific quality of life (rheumatism)
timeFrame: week 24 (inpatient), week 34/35 (day clinic)
measure: disease activity (fibromyalgia syndrome)
timeFrame: week 0
measure: disease activity (fibromyalgia syndrome)
timeFrame: week 2 (inpatient), week 10/11 (day clinic)
measure: disease activity (fibromyalgia syndrome)
timeFrame: week 24 (inpatient), week 34/35 (day clinic)
measure: symptom severity (fibromyalgia syndrome)
timeFrame: week 0
measure: symptom severity (fibromyalgia syndrome)
timeFrame: week 2 (inpatient), week 10/11 (day clinic)
measure: symptom severity (fibromyalgia syndrome)
timeFrame: week 24 (inpatient), week 34/35 (day clinic)
measure: symptom severity - depression and anxiety (fibromyalgia syndrome)
timeFrame: week 0
measure: symptom severity - depression and anxiety (fibromyalgia syndrome)
timeFrame: week 2 (inpatient), week 10/11 (day clinic)
measure: symptom severity - depression and anxiety (fibromyalgia syndrome)
timeFrame: week 24 (inpatient), week 34/35 (day clinic)
measure: diseasespecific quality of life (fibromyalgia syndrome)
timeFrame: week 0
measure: diseasespecific quality of life (fibromyalgia syndrome)
timeFrame: week 2 (inpatient), week 10/11 (day clinic)
measure: diseasespecific quality of life (fibromyalgia syndrome)
timeFrame: week 24 (inpatient), week 34/35 (day clinic)
measure: EQ-5D-5L Five dimensions of quality of life
timeFrame: week 0
measure: EQ-5D-5L Five dimensions of quality of life
timeFrame: week 2 (inpatient), week 10/11 (day clinic)
measure: EQ-5D-5L Five dimensions of quality of life
timeFrame: week 24 (inpatient), week 34/35 (day clinic)
measure: Pain and impairment (post-covid-19)
timeFrame: week 0 (inpatient stay)
measure: Pain and impairment (post-covid-19)
timeFrame: week 2 (inpatient stay)
measure: Pain and impairment (post-covid-19)
timeFrame: week 24 (inpatient stay)
measure: Lactoferrin (chronic gastroenterological)
timeFrame: week 0 (inpatient stay)
measure: Lactoferrin (chronic gastroenterological)
timeFrame: week 2 (inpatient stay)
measure: Lactoferrin (chronic gastroenterological)
timeFrame: week 24 (inpatient stay)
measure: Calprotectin (chronic gastroenterological)
timeFrame: week 0 (inpatient stay)
measure: Calprotectin (chronic gastroenterological)
timeFrame: week 2 (inpatient stay)
measure: Calprotectin (chronic gastroenterological)
timeFrame: week 24 (inpatient stay)
measure: PMN-Elastase (chronic gastroenterological)
timeFrame: week 0 (inpatient stay)
measure: PMN-Elastase (chronic gastroenterological)
timeFrame: week 2 (inpatient stay)
measure: PMN-Elastase (chronic gastroenterological)
timeFrame: week 24 (inpatient stay)
measure: Humanes Beta-Defensin (hBD-2) (chronic gastroenterological)
timeFrame: week 0 (inpatient stay)
measure: Humanes Beta-Defensin (hBD-2) (chronic gastroenterological)
timeFrame: week 2 (inpatient stay)
measure: Humanes Beta-Defensin (hBD-2) (chronic gastroenterological)
timeFrame: week 24 (inpatient stay)
measure: Zonulin (chronic gastroenterological)
timeFrame: week 0 (inpatient stay)
measure: Zonulin (chronic gastroenterological)
timeFrame: week 2 (inpatient stay)
measure: Zonulin (chronic gastroenterological)
timeFrame: week 24 (inpatient stay)
measure: Alpha-Antitrypsin (chronic gastroenterological)
timeFrame: week 0 (inpatient stay)
measure: Alpha-Antitrypsin (chronic gastroenterological)
timeFrame: week 2 (inpatient stay)
measure: Alpha-Antitrypsin (chronic gastroenterological)
timeFrame: week 24 (inpatient stay - follow-up)
measure: CRP (C-reactive protein)
timeFrame: week 0 (inpatient stay)
measure: CRP (C-reactive protein)
timeFrame: week 2 (inpatient stay)
measure: BKS (blood cell sedimentation rate)
timeFrame: week 0 (inpatient stay)
measure: BKS (blood cell sedimentation rate)
timeFrame: week 2 (inpatient stay)
measure: I-FABP (chronic gastroenterological - substudy)
timeFrame: inpatient stay (baseline)
measure: I-FABP (chronic gastroenterological - substudy)
timeFrame: inpatient stay (up to 24 weeks)
measure: IgG/IgG4 (chronic gastroenterological - substudy)
timeFrame: inpatient stay (baseline)
measure: IgG/IgG4 (chronic gastroenterological - substudy)
timeFrame: inpatient stay (up to 24 weeks)
measure: IgE (chronic gastroenterological - substudy)
timeFrame: inpatient stay (baseline)
measure: IgE (chronic gastroenterological - substudy)
timeFrame: inpatient stay (up to 24 weeks)
measure: tissue samples (chronic gastroenterological - substudy)
timeFrame: inpatient stay (baseline)
measure: tissue samples (chronic gastroenterological - substudy)
timeFrame: inpatient stay (up to 24 weeks)
measure: diseasespecific quality of life (oncological patients)
timeFrame: week 0 (day clinic)
measure: diseasespecific quality of life (oncological patients)
timeFrame: week 11 (day clinic)
measure: diseasespecific quality of life (oncological patients)
timeFrame: week 36 (day clinic)
measure: psychological burden (oncological patients)
timeFrame: week 0 (day clinic)
measure: psychological burden (oncological patients)
timeFrame: week 11 (day clinic)
measure: psychological burden (oncological patients)
timeFrame: week 36 (day clinic)
measure: monitoring of the main complaints (other diseases)
timeFrame: week 0 (day clinic)
measure: monitoring of the main complaints (other diseases)
timeFrame: week 10 (day clinic)
measure: monitoring of the main complaints (other diseases)
timeFrame: week 36 (day clinic)
measure: Questionnaire to assess disability due to inflammatory rheumatic joint disease
timeFrame: week 0 (day clinic)
measure: Questionnaire to assess disability due to inflammatory rheumatic joint disease
timeFrame: week 10 (day clinic)
measure: Questionnaire to assess disability due to inflammatory rheumatic joint disease
timeFrame: week 36 (day clinic)
measure: Post-COVID autoantibody screening and T-cell activation assay (Elispot) of potentially reactivated latent pathogens
timeFrame: week 0 (inpatient stay)
measure: Post-COVID autoantibody screening and T-cell activation assay (Elispot) of potentially reactivated latent pathogens
timeFrame: week 2 (inpatient stay)
measure: Questionnaire to measure the severity of tiredness in fatiguing illnesses (Post-Covid-19 syndrome)
timeFrame: week 0 (day clinic)
measure: Questionnaire to measure the severity of tiredness in fatiguing illnesses (Post-Covid-19 syndrome)
timeFrame: week 10 (day clinic)
measure: Questionnaire to measure the severity of tiredness in fatiguing illnesses (Post-Covid-19 syndrome)
timeFrame: week 36 (day clinic)
measure: PSQI - Questionnaire which assesses sleep quality and disturbances (Post-Covid-19 Syndrome)
timeFrame: week 0 (day clinic)
measure: PSQI - Questionnaire which assesses sleep quality and disturbances (Post-Covid-19 Syndrome)
timeFrame: week 11 (day clinic)
measure: PSQI - Questionnaire which assesses sleep quality and disturbances (Post-Covid-19 Syndrome)
timeFrame: week 36 (day clinic)
measure: MFI-20 - Multidimensional Fatigue Inventory (Post-Covid-19 Syndrome, substudy StaPoCo)
timeFrame: week 0 (inpatient stay)
measure: MFI-20 - Multidimensional Fatigue Inventory (Post-Covid-19 Syndrome, substudy StaPoCo)
timeFrame: week 2 (inpatient stay)
measure: MFI-20 - Multidimensional Fatigue Inventory (Post-Covid-19 Syndrome, substudy StaPoCo)
timeFrame: week 24 (inpatient stay)
Other outcomes:
Locations:
city: Bamberg
country: Germany
facility: Sozialstiftung Bamberg, Klinik für Intergrative Medizin
state: Bayern
city: Berlin-Wannsee
country: Germany
facility: Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus Berlin, Standort Berlin-Wannsee
city: Essen
country: Germany
facility: Evang. Kliniken Essen-Mitte, Klinik für Naturheilkunde & Integrative Medizin
Study officials:
affiliation: Sozialstiftung Bamberg, Klinik für Integrative Medizin und Naturheilkunde
name: Jost Langhorst, Prof.
role: PRINCIPAL_INVESTIGATOR
References: