Integrative Therapy of Chronic Diseases (InteChron)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Disease
• Intervention / Treatment: Other: multimodal integrative naturopathic therapy concept

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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Jost Langhorst, Prof.; Phone Number: 0049951-503-11251; Email: jost.langhorst@sozialstiftung-bamberg.de
• Study Contact Backup: Name: Christine Uecker; Phone Number: 0049951-503-16932; Email: christine.uecker@sozialstiftung-bamberg.de

Study Locations

• Germany
  • Bayern
    • Bamberg, Bayern, Germany, 96049
      • Recruiting
      • Sozialstiftung Bamberg, Klinik für Intergrative Medizin
      • Contact: Jost Langhorst, Prof.; Phone Number: 0049951-503-11251; Email: jost.langhorst@sozialstiftung-bamberg.de
      • Contact: Christine Uecker; Phone Number: 0049951-503-16932; Email: christine.uecker@sozialstiftung-bamberg.de
      • Principal Investigator: Jost Langhorst, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chronic gastroenterological diseases - inpatient stay and day clinic; Irritable Bowel Syndrome, Crohn's disease, Ulcerative colitis	Other: 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	Other: 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	Other: 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	Other: 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.	Other: multimodal integrative naturopathic therapy concept; Use of conventional medicine, naturopathic approaches and complementary medical therapy methods

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Generic quality of life	SF-12, Short Form 36 Health Survey Questionnaire	week 0
Generic quality of life	SF-12, Short Form 36 Health Survey Questionnaire	week 2 (inpatient), week 10/11 (day clinic)
Generic quality of life	SF-12, Short Form 36 Health Survey Questionnaire	week 24 (inpatient), week 34/35 (day clinic)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
anxiety and depression	Hospital Anxiety and Depression Scale (HADS), 14 items (7 each for depressive symptoms or symptoms of anxiety). The two summated scores of the summated scales HADS-A and HADS-D range between 0 and 21. high scores indicate depressivness and anxiety	week 0
anxiety and depression	Hospital Anxiety and Depression Scale (HADS), 14 items (7 each for depressive symptoms or symptoms of anxiety). The two summated scores of the summated scales HADS-A and HADS-D range between 0 and 21. high scores indicate depressivness and anxiety	week 2 (inpatient), week 10/11 (day clinic)
anxiety and depression	Hospital Anxiety and Depression Scale (HADS), 14 items (7 each for depressive symptoms or symptoms of anxiety). The two summated scores of the summated scales HADS-A and HADS-D range between 0 and 21. high scores indicate depressivness and anxiety	week 24 (inpatient), week 34/35 (day clinic)
sex	identification of the gender	week 0
age	age in years	week 0
job	identification of the current job (questionnaire)	week 0
Educational level	identification of the educational level (questionnaire)	week 0
Expectation of the treatment (questionnaire)	patient's expectations regarding treatment	week 0
Use of complementary medicine/natural remedies (questionnaire)	medication and naturopathic approaches	week 0
Course of the disease (questionnaire)	diagnosis, treatment methods, medication	week 0
wellbeing/flourishing	Flourishing Scale (FS-D), total value of the scale vary between 8 (minimum) and 56 (maximum). A high value corresponds to a person with many psychological resources and strengths	week 0 (inpatient stay)
wellbeing/flourishing	Flourishing Scale (FS-D), total value of the scale vary between 8 (minimum) and 56 (maximum). A high value corresponds to a person with many psychological resources and strengths	week 2 (inpatient stay)
wellbeing/flourishing	Flourishing Scale (FS-D), total value of the scale vary between 8 (minimum) and 56 (maximum). A high value corresponds to a person with many psychological resources and strengths	week 24 (inpatient stay)
Perceived stress	Perceived Stress Scale (PSS), Rating on a five-step scale from 1 (=never) to 5 (=very often), high stress is assumed from a total score of 20 points	week 0
Perceived stress	Perceived Stress Scale (PSS), Rating on a five-step scale from 1 (=never) to 5 (=very often), high stress is assumed from a total score of 20 points	week 2 (inpatient), week 10/11 (day clinic)
Perceived stress	Perceived Stress Scale (PSS), Rating on a five-step scale from 1 (=never) to 5 (=very often), high stress is assumed from a total score of 20 points	week 24 (inpatient), week 34/35 (day clinic)
disease activity (irritable bowel syndrome)	IBS-SSS: To assess or evaluate the severity of the disease; the questionnaire includes 5 dimensions assessed with a visual analog scale (VAS): Severity of abdominal pain, frequency of abdominal pain, severity of abdominal distension, dissatisfaction with bowel habits, and impairment of quality of life.	week 0
disease activity (irritable bowel syndrome)	IBS-SSS: To assess or evaluate the severity of the disease; the questionnaire includes 5 dimensions assessed with a visual analog scale (VAS): Severity of abdominal pain, frequency of abdominal pain, severity of abdominal distension, dissatisfaction with bowel habits, and impairment of quality of life.	week 2 (inpatient), week 10/11 (day clinic)
disease activity (irritable bowel syndrome)	IBS-SSS: To assess or evaluate the severity of the disease; the questionnaire includes 5 dimensions assessed with a visual analog scale (VAS): Severity of abdominal pain, frequency of abdominal pain, severity of abdominal distension, dissatisfaction with bowel habits, and impairment of quality of life.	week 24 (inpatient), week 34/35 (day clinic)
diseasespecific quality of life (irritable bowel syndrome)	The Irritable Bowel Syndrome Quality of Life (IBS-QOL) ; these are 34 items that reflect the impact of IBS on everyday life (0-100 points).	week 0
diseasespecific quality of life (irritable bowel syndrome)	The Irritable Bowel Syndrome Quality of Life (IBS-QOL) ; these are 34 items that reflect the impact of IBS on everyday life (0-100 points).	week 2 (inpatient), week 10/11 (day clinic)
diseasespecific quality of life (irritable bowel syndrome)	The Irritable Bowel Syndrome Quality of Life (IBS-QOL) ; these are 34 items that reflect the impact of IBS on everyday life (0-100 points).	week 24 (inpatient), week 34/35 (day clinic)
Partial Mayo Score, disease activity (ulcerative colitis)	The Partial Mayo Scoring Index consists of a few questions for the patient to answer, and one question for the physician to answer. The numerical results provide a score that represents an estimate of ulcerative colitis disease severity.	week 0
Partial Mayo Score, disease activity (ulcerative colitis)	The Partial Mayo Scoring Index consists of a few questions for the patient to answer, and one question for the physician to answer. The numerical results provide a score that represents an estimate of ulcerative colitis disease severity.	week 2 (inpatient), week 10/11 (day clinic)
Partial Mayo Score, disease activity (ulcerative colitis)	The Partial Mayo Scoring Index consists of a few questions for the patient to answer, and one question for the physician to answer. The numerical results provide a score that represents an estimate of ulcerative colitis disease severity.	week 24 (inpatient), week 34/35 (day clinic)
diseasespecific quality of life (ulcerative colitis)	Inflammatory Bowel Disease Questionnaire (IBD-Q), Recording on 7-point Likert scale, high values mean good, low values a reduced quality of life (1=worst score, 7=best score)	week 0
diseasespecific quality of life (ulcerative colitis)	Inflammatory Bowel Disease Questionnaire (IBD-Q), Recording on 7-point Likert scale, high values mean good, low values a reduced quality of life (1=worst score, 7=best score)	week 2 (inpatient), week 10/11 (day clinic)
diseasespecific quality of life (ulcerative colitis)	Inflammatory Bowel Disease Questionnaire (IBD-Q), Recording on 7-point Likert scale, high values mean good, low values a reduced quality of life (1=worst score, 7=best score)	week 24 (inpatient), week 34/35 (day clinic)
disease activity (Crohn's disease)	Harvey-Bradshaw Index - HBI is used to assess the degree of illness in individuals with Crohn's disease. The highest possible sum is 30 points and indicates a severe course of disease. A lower sum than 5 points indicates a clinical remission.	week 0
disease activity (Crohn's disease)	Harvey-Bradshaw Index - HBI is used to assess the degree of illness in individuals with Crohn's disease. The highest possible sum is 30 points and indicates a severe course of disease. A lower sum than 5 points indicates a clinical remission.	week 2 (inpatient), week 10/11 (day clinic)
disease activity (Crohn's disease)	Harvey-Bradshaw Index - HBI is used to assess the degree of illness in individuals with Crohn's disease. The highest possible sum is 30 points and indicates a severe course of disease. A lower sum than 5 points indicates a clinical remission.	week 24 (inpatient), week 34/35 (day clinic)
diseasespecific quality of life (Crohn's disease)	Inflammatory Bowel Disease Questionnaire (IBD-Q), Recording on 7-point Likert scale, high values mean good, low values a reduced quality of life (1=worst score, 7=best score)	week 0
diseasespecific quality of life (Crohn's disease)	Inflammatory Bowel Disease Questionnaire (IBD-Q), Recording on 7-point Likert scale, high values mean good, low values a reduced quality of life (1=worst score, 7=best score)	week 2 (inpatient), week 10/11 (day clinic)
diseasespecific quality of life (Crohn's disease)	Inflammatory Bowel Disease Questionnaire (IBD-Q), Recording on 7-point Likert scale, high values mean good, low values a reduced quality of life (1=worst score, 7=best score)	week 24 (inpatient), week 34/35 (day clinic)
disease activity (pain patients)	Dt. Schmerzfragebogen/ Schweregraduierung nach von Korff -The intensity of the pain is determined with the help of the severity grading according to von Korff. On an 11-step rating scale (0 = no pain to 10 = strongest pain imaginable), the current, average and greatest pain intensity in the past 4 weeks is recorded. In addition, the extent of pain-related, subjectively experienced impairment is recorded for the areas of everyday life, leisure activities and ability to work.	week 0
disease activity (pain patients)	Dt. Schmerzfragebogen/ Schweregraduierung nach von Korff -The intensity of the pain is determined with the help of the severity grading according to von Korff. On an 11-step rating scale (0 = no pain to 10 = strongest pain imaginable), the current, average and greatest pain intensity in the past 4 weeks is recorded. In addition, the extent of pain-related, subjectively experienced impairment is recorded for the areas of everyday life, leisure activities and ability to work.	week 2 (inpatient), week 10/11 (day clinic)
disease activity (pain patients)	Dt. Schmerzfragebogen/ Schweregraduierung nach von Korff -The intensity of the pain is determined with the help of the severity grading according to von Korff. On an 11-step rating scale (0 = no pain to 10 = strongest pain imaginable), the current, average and greatest pain intensity in the past 4 weeks is recorded. In addition, the extent of pain-related, subjectively experienced impairment is recorded for the areas of everyday life, leisure activities and ability to work.	week 24 (inpatient), week 34/35 (day clinic)
diseasespecific quality of life (pain patients)	The Pain Disability Index (PDI) was developed specifically for patients with pain. The German-language translation (Dillmann et al., 1994), which is consistent with the original in terms of content and form, consists of seven items that assess the impact of pain on individual domains of life: family and domestic obligations, leisure activities, social activities, occupation, sexual life, self-care, and activities essential to life. For each area, the patient is asked to indicate on an eleven-point scale the extent to which he or she is impaired here by his or her pain.	week 0
diseasespecific quality of life (pain patients)	The Pain Disability Index (PDI) was developed specifically for patients with pain. The German-language translation (Dillmann et al., 1994), which is consistent with the original in terms of content and form, consists of seven items that assess the impact of pain on individual domains of life: family and domestic obligations, leisure activities, social activities, occupation, sexual life, self-care, and activities essential to life. For each area, the patient is asked to indicate on an eleven-point scale the extent to which he or she is impaired here by his or her pain.	week 2 (inpatient), week 10/11 (day clinic)
diseasespecific quality of life (pain patients)	The Pain Disability Index (PDI) was developed specifically for patients with pain. The German-language translation (Dillmann et al., 1994), which is consistent with the original in terms of content and form, consists of seven items that assess the impact of pain on individual domains of life: family and domestic obligations, leisure activities, social activities, occupation, sexual life, self-care, and activities essential to life. For each area, the patient is asked to indicate on an eleven-point scale the extent to which he or she is impaired here by his or her pain.	week 24 (inpatient), week 34/35 (day clinic)
disease activity (rheumatism)	The DAS (Disease Activity Score) is a scoring system developed by the European League of Rheumatism (EULAR). With the DAS28, the disease activity of rheumatoid arthritis is recorded on the basis of 28 defined joints (finger, hand, large joints) and a score between 0 and 10 is determined.	week 0
disease activity (rheumatism)	The DAS (Disease Activity Score) is a scoring system developed by the European League of Rheumatism (EULAR). With the DAS28, the disease activity of rheumatoid arthritis is recorded on the basis of 28 defined joints (finger, hand, large joints) and a score between 0 and 10 is determined.	week 2 (inpatient), week 10/11 (day clinic)
disease activity (rheumatism)	The DAS (Disease Activity Score) is a scoring system developed by the European League of Rheumatism (EULAR). With the DAS28, the disease activity of rheumatoid arthritis is recorded on the basis of 28 defined joints (finger, hand, large joints) and a score between 0 and 10 is determined.	week 24 (inpatient), week 34/35 (day clinic)
diseasespecific quality of life (rheumatism)	Rheumatoid Arthritis Impact of Disease (RAID): Rheumatoid Arthritis Symptom Burden Questionnaire. The current questionnaire contains numeric scales from 0 to 10 for the assessment of pain, sleep, fatigue/exhaustion, impaired functioning, psychological well-being, situational awareness, and physical well-being.	week 0
diseasespecific quality of life (rheumatism)	Rheumatoid Arthritis Impact of Disease (RAID): Rheumatoid Arthritis Symptom Burden Questionnaire. The current questionnaire contains numeric scales from 0 to 10 for the assessment of pain, sleep, fatigue/exhaustion, impaired functioning, psychological well-being, situational awareness, and physical well-being.	week 2 (inpatient), week 10/11 (day clinic)
diseasespecific quality of life (rheumatism)	Rheumatoid Arthritis Impact of Disease (RAID): Rheumatoid Arthritis Symptom Burden Questionnaire. The current questionnaire contains numeric scales from 0 to 10 for the assessment of pain, sleep, fatigue/exhaustion, impaired functioning, psychological well-being, situational awareness, and physical well-being.	week 24 (inpatient), week 34/35 (day clinic)
disease activity and diseasespecific quality of life (rheumatism)	Dt. Schmerzfragebogen/ Schweregraduierung nach von Korff -The intensity of the pain is determined with the help of the severity grading according to von Korff. On an 11-step rating scale (0 = no pain to 10 = strongest pain imaginable), the current, average and greatest pain intensity in the past 4 weeks is recorded. In addition, the extent of pain-related, subjectively experienced impairment is recorded for the areas of everyday life, leisure activities and ability to work.	week 0
disease activity and diseasespecific quality of life (rheumatism)	Dt. Schmerzfragebogen/ Schweregraduierung nach von Korff -The intensity of the pain is determined with the help of the severity grading according to von Korff. On an 11-step rating scale (0 = no pain to 10 = strongest pain imaginable), the current, average and greatest pain intensity in the past 4 weeks is recorded. In addition, the extent of pain-related, subjectively experienced impairment is recorded for the areas of everyday life, leisure activities and ability to work.	week 2 (inpatient), week 10/11 (day clinic)
disease activity and diseasespecific quality of life (rheumatism)	Dt. Schmerzfragebogen/ Schweregraduierung nach von Korff -The intensity of the pain is determined with the help of the severity grading according to von Korff. On an 11-step rating scale (0 = no pain to 10 = strongest pain imaginable), the current, average and greatest pain intensity in the past 4 weeks is recorded. In addition, the extent of pain-related, subjectively experienced impairment is recorded for the areas of everyday life, leisure activities and ability to work.	week 24 (inpatient), week 34/35 (day clinic)
disease activity (fibromyalgia syndrome)	Fibromyalgia Symptom Questionnaire (FSQ) captures the severity of key fibromyalgia syndrome symptoms and the presence of various pain points over time in four sections.	week 0
disease activity (fibromyalgia syndrome)	Fibromyalgia Symptom Questionnaire (FSQ) captures the severity of key fibromyalgia syndrome symptoms and the presence of various pain points over time in four sections.	week 2 (inpatient), week 10/11 (day clinic)
disease activity (fibromyalgia syndrome)	Fibromyalgia Symptom Questionnaire (FSQ) captures the severity of key fibromyalgia syndrome symptoms and the presence of various pain points over time in four sections.	week 24 (inpatient), week 34/35 (day clinic)
symptom severity (fibromyalgia syndrome)	Patient Health Questionnaire 15 (PHQ-15) consists of 15 items in the area of somatoform and depressive disorders. The PHQ-15 is scored by forming a sum score across all items. Symptom severity is assessed by the total score: minimal, mild, moderate, or severe.	week 0
symptom severity (fibromyalgia syndrome)	Patient Health Questionnaire 15 (PHQ-15) consists of 15 items in the area of somatoform and depressive disorders. The PHQ-15 is scored by forming a sum score across all items. Symptom severity is assessed by the total score: minimal, mild, moderate, or severe.	week 2 (inpatient), week 10/11 (day clinic)
symptom severity (fibromyalgia syndrome)	Patient Health Questionnaire 15 (PHQ-15) consists of 15 items in the area of somatoform and depressive disorders. The PHQ-15 is scored by forming a sum score across all items. Symptom severity is assessed by the total score: minimal, mild, moderate, or severe.	week 24 (inpatient), week 34/35 (day clinic)
symptom severity - depression and anxiety (fibromyalgia syndrome)	PHQ-4 captures the dimensions of depression and anxiety with 4 items; patients are asked to indicate how often certain complaints (e.g., little happiness, dejection, anxiety) occurred over the course of the past two weeks	week 0
symptom severity - depression and anxiety (fibromyalgia syndrome)	PHQ-4 captures the dimensions of depression and anxiety with 4 items; patients are asked to indicate how often certain complaints (e.g., little happiness, dejection, anxiety) occurred over the course of the past two weeks	week 2 (inpatient), week 10/11 (day clinic)
symptom severity - depression and anxiety (fibromyalgia syndrome)	PHQ-4 captures the dimensions of depression and anxiety with 4 items; patients are asked to indicate how often certain complaints (e.g., little happiness, dejection, anxiety) occurred over the course of the past two weeks	week 24 (inpatient), week 34/35 (day clinic)
diseasespecific quality of life (fibromyalgia syndrome)	The Fibromyalgia Impact Questionnaire (FIQ) is an instrument that quantifies the general impact of fibromyalgia syndrome in many dimensions. For example, it assesses functional ability, pain levels, fatigue, and sleep disturbances in patients affected by FMS. The FIQ is presented on a scale of 0-100, with a lower number indicating better health. It is a sensitive tool for therapy evaluation in fibromyalgia.	week 0
diseasespecific quality of life (fibromyalgia syndrome)	The Fibromyalgia Impact Questionnaire (FIQ) is an instrument that quantifies the general impact of fibromyalgia syndrome in many dimensions. For example, it assesses functional ability, pain levels, fatigue, and sleep disturbances in patients affected by FMS. The FIQ is presented on a scale of 0-100, with a lower number indicating better health. It is a sensitive tool for therapy evaluation in fibromyalgia.	week 2 (inpatient), week 10/11 (day clinic)
diseasespecific quality of life (fibromyalgia syndrome)	The Fibromyalgia Impact Questionnaire (FIQ) is an instrument that quantifies the general impact of fibromyalgia syndrome in many dimensions. For example, it assesses functional ability, pain levels, fatigue, and sleep disturbances in patients affected by FMS. The FIQ is presented on a scale of 0-100, with a lower number indicating better health. It is a sensitive tool for therapy evaluation in fibromyalgia.	week 24 (inpatient), week 34/35 (day clinic)
EQ-5D-5L Five dimensions of quality of life	Dt. This questionnaire assesses the state of health (mobility, self-care, general activities, pain/physical discomfort and anxiety/dejection) as well as general health status on a VAS of 0-100. The questionnaire assesses is used for Post-Covid-Patients.	week 0
EQ-5D-5L Five dimensions of quality of life	Dt. This questionnaire assesses the state of health (mobility, self-care, general activities, pain/physical discomfort and anxiety/dejection) as well as general health status on a VAS of 0-100. The questionnaire assesses is used for Post-Covid-Patients.	week 2 (inpatient), week 10/11 (day clinic)
EQ-5D-5L Five dimensions of quality of life	This questionnaire assesses the state of health (mobility, self-care, general activities, pain/physical discomfort and anxiety/dejection) as well as general health status on a VAS of 0-100. The questionnaire assesses is used for Post-Covid-Patients.	week 24 (inpatient), week 34/35 (day clinic)
Pain and impairment (post-covid-19)	Dt. Brief pain inventory (BPI). It is used for Post-Covid-Patients. This questionnaire asks about pain and impairments in everyday life that occur due to these	week 0 (inpatient stay)
Pain and impairment (post-covid-19)	Dt. Brief pain inventory (BPI). It is used for Post-Covid-Patients. This questionnaire asks about pain and impairments in everyday life that occur due to these.	week 2 (inpatient stay)
Pain and impairment (post-covid-19)	Dt. Brief pain inventory (BPI). It is used for Post-Covid-Patients. This questionnaire asks about pain and impairments in everyday life that occur due to these	week 24 (inpatient stay)
Lactoferrin (chronic gastroenterological)	Determination of lactoferrin in the stool	week 0 (inpatient stay)
Lactoferrin (chronic gastroenterological)	Determination of lactoferrin in the stool	week 2 (inpatient stay)
Lactoferrin (chronic gastroenterological)	Determination of lactoferrin in the stool	week 24 (inpatient stay)
Calprotectin (chronic gastroenterological)	Determination of calprotectin in the stool	week 0 (inpatient stay)
Calprotectin (chronic gastroenterological)	Determination of calprotectinin the stool	week 2 (inpatient stay)
Calprotectin (chronic gastroenterological)	Determination of calprotectin in the stool	week 24 (inpatient stay)
PMN-Elastase (chronic gastroenterological)	Determination of PMN-Elastase in the stool	week 0 (inpatient stay)
PMN-Elastase (chronic gastroenterological)	Determination of PMN-Elastasethe in the stool	week 2 (inpatient stay)
PMN-Elastase (chronic gastroenterological)	Determination of PMN-Elastasethe in the stool	week 24 (inpatient stay)
Humanes Beta-Defensin (hBD-2) (chronic gastroenterological)	Determination of Humanes Beta-Defensin (hBD-2) in the stool	week 0 (inpatient stay)
Humanes Beta-Defensin (hBD-2) (chronic gastroenterological)	Determination of Humanes Beta-Defensin (hBD-2) in the stool	week 2 (inpatient stay)
Humanes Beta-Defensin (hBD-2) (chronic gastroenterological)	Determination of Humanes Beta-Defensin (hBD-2) in the stool	week 24 (inpatient stay)
Zonulin (chronic gastroenterological)	Determination of zonulin in the stool	week 0 (inpatient stay)
Zonulin (chronic gastroenterological)	Determination of zonulin in the stool	week 2 (inpatient stay)
Zonulin (chronic gastroenterological)	Determination of zonulin in the stool	week 24 (inpatient stay)
Alpha-Antitrypsin (chronic gastroenterological)	Determination of Alpha-Antitrypsin in the stool	week 0 (inpatient stay)
Alpha-Antitrypsin (chronic gastroenterological)	Determination of Alpha-Antitrypsin in the stool	week 2 (inpatient stay)
Alpha-Antitrypsin (chronic gastroenterological)	Determination of Alpha-Antitrypsin in the stool	week 24 (inpatient stay - follow-up)
CRP (C-reactive protein)	Determination of CRP in the blood	week 0 (inpatient stay)
CRP (C-reactive protein)	Determination of CRP in the blood	week 2 (inpatient stay)
BKS (blood cell sedimentation rate)	Determination of BKS in the blood	week 0 (inpatient stay)
BKS (blood cell sedimentation rate)	Determination of BKS in the blood	week 2 (inpatient stay)
I-FABP (chronic gastroenterological - substudy)	intestinal fatty-acid binding protein (blood)	inpatient stay (baseline)
I-FABP (chronic gastroenterological - substudy)	intestinal fatty-acid binding protein (blood)	inpatient stay (up to 24 weeks)
IgG/IgG4 (chronic gastroenterological - substudy)	immunoglobuline-G (blood)	inpatient stay (baseline)
IgG/IgG4 (chronic gastroenterological - substudy)	immunoglobuline-G (blood)	inpatient stay (up to 24 weeks)
IgE (chronic gastroenterological - substudy)	immunoglobuline-E (blood)	inpatient stay (baseline)
IgE (chronic gastroenterological - substudy)	immunoglobuline-E (blood)	inpatient stay (up to 24 weeks)
tissue samples (chronic gastroenterological - substudy)	Immunochemistry and gene expression analysis	inpatient stay (baseline)
tissue samples (chronic gastroenterological - substudy)	Immunochemistry and gene expression analysis	inpatient stay (up to 24 weeks)
diseasespecific quality of life (oncological patients)	QLQ-C30: The EORTC QLQ-C30 questionnaire contains 30 questions and assesses the quality of life of oncological patients multidimensionally via 10 subscales. There are a number of additional modules for the disease-specific assessment of oncology patients.	week 0 (day clinic)
diseasespecific quality of life (oncological patients)	QLQ-C30: The EORTC QLQ-C30 questionnaire contains 30 questions and assesses the quality of life of oncological patients multidimensionally via 10 subscales. There are a number of additional modules for the disease-specific assessment of oncology patients.	week 11 (day clinic)
diseasespecific quality of life (oncological patients)	QLQ-C30: The EORTC QLQ-C30 questionnaire contains 30 questions and assesses the quality of life of oncological patients multidimensionally via 10 subscales. There are a number of additional modules for the disease-specific assessment of oncology patients.	week 36 (day clinic)
psychological burden (oncological patients)	FBK-R23: Questionnaire on the Burden of Cancer Patients, 23 items on psychological, somatic and social burden.	week 0 (day clinic)
psychological burden (oncological patients)	FBK-R23: Questionnaire on the Burden of Cancer Patients, 23 items on psychological, somatic and social burden.	week 11 (day clinic)
psychological burden (oncological patients)	FBK-R23: Questionnaire on the Burden of Cancer Patients, 23 items on psychological, somatic and social burden.	week 36 (day clinic)
monitoring of the main complaints (other diseases)	MYMOP: Measure Yourself Medical Outcome Profile	week 0 (day clinic)
monitoring of the main complaints (other diseases)	MYMOP: Measure Yourself Medical Outcome Profile	week 10 (day clinic)
monitoring of the main complaints (other diseases)	MYMOP: Measure Yourself Medical Outcome Profile	week 36 (day clinic)
Questionnaire to assess disability due to inflammatory rheumatic joint disease	HAQ: Health assessment questionnaire, The patient fills out this questionnaire himself, assessing his ability to perform the following activities in eight daily functional areas: Dressing, standing up, eating, walking, personal hygiene, handing objects, grasping, other activities.	week 0 (day clinic)
Questionnaire to assess disability due to inflammatory rheumatic joint disease	HAQ: Health assessment questionnaire, The patient fills out this questionnaire himself, assessing his ability to perform the following activities in eight daily functional areas: Dressing, standing up, eating, walking, personal hygiene, handing objects, grasping, other activities.	week 10 (day clinic)
Questionnaire to assess disability due to inflammatory rheumatic joint disease	HAQ: Health assessment questionnaire, The patient fills out this questionnaire himself, assessing his ability to perform the following activities in eight daily functional areas: Dressing, standing up, eating, walking, personal hygiene, handing objects, grasping, other activities.	week 36 (day clinic)
Post-COVID autoantibody screening and T-cell activation assay (Elispot) of potentially reactivated latent pathogens	blood collection (substudy StaPoCo)	week 0 (inpatient stay)
Post-COVID autoantibody screening and T-cell activation assay (Elispot) of potentially reactivated latent pathogens	blood collection (substudy StaPoCo)	week 2 (inpatient stay)
Questionnaire to measure the severity of tiredness in fatiguing illnesses (Post-Covid-19 syndrome)	Chalder Fatigue Scale	week 0 (day clinic)
Questionnaire to measure the severity of tiredness in fatiguing illnesses (Post-Covid-19 syndrome)	Chalder Fatigue Scale	week 10 (day clinic)
Questionnaire to measure the severity of tiredness in fatiguing illnesses (Post-Covid-19 syndrome)	Chalder Fatigue Scale	week 36 (day clinic)
PSQI - Questionnaire which assesses sleep quality and disturbances (Post-Covid-19 Syndrome)	PSQI Pittsburgh Sleep Quality Index	week 0 (day clinic)
PSQI - Questionnaire which assesses sleep quality and disturbances (Post-Covid-19 Syndrome)	PSQI Pittsburgh Sleep Quality Index	week 11 (day clinic)
PSQI - Questionnaire which assesses sleep quality and disturbances (Post-Covid-19 Syndrome)	PSQI Pittsburgh Sleep Quality Index	week 36 (day clinic)
MFI-20 - Multidimensional Fatigue Inventory (Post-Covid-19 Syndrome, substudy StaPoCo)	20-items rated on a 5-point scale (1 = "yes, that is true" to 5 = "no, that is not true") designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Higher scores represent more fatigue.	week 0 (inpatient stay)
MFI-20 - Multidimensional Fatigue Inventory (Post-Covid-19 Syndrome, substudy StaPoCo)	20-items rated on a 5-point scale (1 = "yes, that is true" to 5 = "no, that is not true") designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Higher scores represent more fatigue.	week 2 (inpatient stay)
MFI-20 - Multidimensional Fatigue Inventory (Post-Covid-19 Syndrome, substudy StaPoCo)	20-items rated on a 5-point scale (1 = "yes, that is true" to 5 = "no, that is not true") designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Higher scores represent more fatigue.	week 24 (inpatient stay)

Collaborators and Investigators

• Sponsor: Universität Duisburg-Essen
• Collaborators: Sozialstiftung Bamberg; Bavarian State Ministry of Health and Care

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2021
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: April 13, 2021
• First Submitted That Met QC Criteria: June 8, 2021
• First Posted (Actual): June 16, 2021

Study Record Updates

• Last Update Posted (Estimate): December 7, 2022
• Last Update Submitted That Met QC Criteria: December 5, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Crohn's disease; ulcerative colitis; complementary medicine; irritable bowel syndrome; integrative medicine; pain patients; rheumatism; fibromyalgia syndrome; naturopathy; irritable bowel disease; chronic pain syndrome; post Covid syndrome; oncological diseases; day clinic
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: 20068 (Other Identifier: City of Hope Comprehensive Cancer Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No