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.
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
1,000
Use of conventional medicine, naturopathic approaches and complementary medical therapy methods
Sozialstiftung Bamberg, Klinik für Intergrative Medizin
Bamberg, Bavaria, Germany
RECRUITINGEvang. Kliniken Essen-Mitte, Klinik für Naturheilkunde & Integrative Medizin
Essen, Germany
RECRUITINGCharité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus Berlin, Standort Berlin-Wannsee
Wannsee, Germany
RECRUITINGGeneric quality of life
SF-12, Short Form 36 Health Survey Questionnaire
Time frame: week 0
Generic quality of life
SF-12, Short Form 36 Health Survey Questionnaire
Time frame: week 2 (inpatient), week 10/11 (day clinic)
Generic quality of life
SF-12, Short Form 36 Health Survey Questionnaire
Time frame: week 24 (inpatient), week 34/35 (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
Time frame: 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
Time frame: 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
Time frame: week 24 (inpatient), week 34/35 (day clinic)
sex
identification of the gender
Time frame: week 0
age
age in years
Time frame: week 0
job
identification of the current job (questionnaire)
Time frame: week 0
Educational level
identification of the educational level (questionnaire)
Time frame: week 0
Expectation of the treatment (questionnaire)
patient's expectations regarding treatment
Time frame: week 0
Use of complementary medicine/natural remedies (questionnaire)
medication and naturopathic approaches
Time frame: week 0
Course of the disease (questionnaire)
diagnosis, treatment methods, medication
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: week 24 (inpatient stay)
Lactoferrin (chronic gastroenterological)
Determination of lactoferrin in the stool
Time frame: week 0 (inpatient stay)
Lactoferrin (chronic gastroenterological)
Determination of lactoferrin in the stool
Time frame: week 2 (inpatient stay)
Lactoferrin (chronic gastroenterological)
Determination of lactoferrin in the stool
Time frame: week 24 (inpatient stay)
Calprotectin (chronic gastroenterological)
Determination of calprotectin in the stool
Time frame: week 0 (inpatient stay)
Calprotectin (chronic gastroenterological)
Determination of calprotectinin the stool
Time frame: week 2 (inpatient stay)
Calprotectin (chronic gastroenterological)
Determination of calprotectin in the stool
Time frame: week 24 (inpatient stay)
PMN-Elastase (chronic gastroenterological)
Determination of PMN-Elastase in the stool
Time frame: week 0 (inpatient stay)
PMN-Elastase (chronic gastroenterological)
Determination of PMN-Elastasethe in the stool
Time frame: week 2 (inpatient stay)
PMN-Elastase (chronic gastroenterological)
Determination of PMN-Elastasethe in the stool
Time frame: week 24 (inpatient stay)
Humanes Beta-Defensin (hBD-2) (chronic gastroenterological)
Determination of Humanes Beta-Defensin (hBD-2) in the stool
Time frame: week 0 (inpatient stay)
Humanes Beta-Defensin (hBD-2) (chronic gastroenterological)
Determination of Humanes Beta-Defensin (hBD-2) in the stool
Time frame: week 2 (inpatient stay)
Humanes Beta-Defensin (hBD-2) (chronic gastroenterological)
Determination of Humanes Beta-Defensin (hBD-2) in the stool
Time frame: week 24 (inpatient stay)
Zonulin (chronic gastroenterological)
Determination of zonulin in the stool
Time frame: week 0 (inpatient stay)
Zonulin (chronic gastroenterological)
Determination of zonulin in the stool
Time frame: week 2 (inpatient stay)
Zonulin (chronic gastroenterological)
Determination of zonulin in the stool
Time frame: week 24 (inpatient stay)
Alpha-Antitrypsin (chronic gastroenterological)
Determination of Alpha-Antitrypsin in the stool
Time frame: week 0 (inpatient stay)
Alpha-Antitrypsin (chronic gastroenterological)
Determination of Alpha-Antitrypsin in the stool
Time frame: week 2 (inpatient stay)
Alpha-Antitrypsin (chronic gastroenterological)
Determination of Alpha-Antitrypsin in the stool
Time frame: week 24 (inpatient stay - follow-up)
CRP (C-reactive protein)
Determination of CRP in the blood
Time frame: week 0 (inpatient stay)
CRP (C-reactive protein)
Determination of CRP in the blood
Time frame: week 2 (inpatient stay)
BKS (blood cell sedimentation rate)
Determination of BKS in the blood
Time frame: week 0 (inpatient stay)
BKS (blood cell sedimentation rate)
Determination of BKS in the blood
Time frame: week 2 (inpatient stay)
I-FABP (chronic gastroenterological - substudy)
intestinal fatty-acid binding protein (blood)
Time frame: inpatient stay (baseline)
I-FABP (chronic gastroenterological - substudy)
intestinal fatty-acid binding protein (blood)
Time frame: inpatient stay (up to 24 weeks)
IgG/IgG4 (chronic gastroenterological - substudy)
immunoglobuline-G (blood)
Time frame: inpatient stay (baseline)
IgG/IgG4 (chronic gastroenterological - substudy)
immunoglobuline-G (blood)
Time frame: inpatient stay (up to 24 weeks)
IgE (chronic gastroenterological - substudy)
immunoglobuline-E (blood)
Time frame: inpatient stay (baseline)
IgE (chronic gastroenterological - substudy)
immunoglobuline-E (blood)
Time frame: inpatient stay (up to 24 weeks)
tissue samples (chronic gastroenterological - substudy)
Immunochemistry and gene expression analysis
Time frame: inpatient stay (baseline)
tissue samples (chronic gastroenterological - substudy)
Immunochemistry and gene expression analysis
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: week 36 (day clinic)
monitoring of the main complaints (other diseases)
MYMOP: Measure Yourself Medical Outcome Profile
Time frame: week 0 (day clinic)
monitoring of the main complaints (other diseases)
MYMOP: Measure Yourself Medical Outcome Profile
Time frame: week 10 (day clinic)
monitoring of the main complaints (other diseases)
MYMOP: Measure Yourself Medical Outcome Profile
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: week 36 (day clinic)
Post-COVID autoantibody screening and T-cell activation assay (Elispot) of potentially reactivated latent pathogens
blood collection (substudy StaPoCo)
Time frame: week 0 (inpatient stay)
Post-COVID autoantibody screening and T-cell activation assay (Elispot) of potentially reactivated latent pathogens
blood collection (substudy StaPoCo)
Time frame: week 2 (inpatient stay)
Questionnaire to measure the severity of tiredness in fatiguing illnesses (Post-Covid-19 syndrome)
Chalder Fatigue Scale
Time frame: week 0 (day clinic)
Questionnaire to measure the severity of tiredness in fatiguing illnesses (Post-Covid-19 syndrome)
Chalder Fatigue Scale
Time frame: week 10 (day clinic)
Questionnaire to measure the severity of tiredness in fatiguing illnesses (Post-Covid-19 syndrome)
Chalder Fatigue Scale
Time frame: week 36 (day clinic)
PSQI - Questionnaire which assesses sleep quality and disturbances (Post-Covid-19 Syndrome)
PSQI Pittsburgh Sleep Quality Index
Time frame: week 0 (day clinic)
PSQI - Questionnaire which assesses sleep quality and disturbances (Post-Covid-19 Syndrome)
PSQI Pittsburgh Sleep Quality Index
Time frame: week 11 (day clinic)
PSQI - Questionnaire which assesses sleep quality and disturbances (Post-Covid-19 Syndrome)
PSQI Pittsburgh Sleep Quality Index
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: week 24 (inpatient stay)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.