Chronic DiseaseInteChronNCT04927403
Integrative Therapy of Chronic Diseases
An observational study of Chronic Disease, run by Universität Duisburg-Essen at 3 sites in Germany.
Trial summary
The observational study aims to investigate the extent to which a two-week stay in an internal medicine clinic for integrative medicine and naturopathy results in an improvement of complaints, impairments, quality of life, anxiety/depressiveness, stress perception and well-being in chronic gastroenterological patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Disease
- What is being tested?
- multimodal integrative naturopathic therapy concept
- How many people
- 1,000 participants
- Where
- 3 sitesGermany
- Study dates
- 4 Jan 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- Patients at least 18 years of age
- signed declaration of consent
Who cannot join
- Patients who have not reached the age of 18.
- Expected life expectancy < 6 months (oncology patients).
Trial locations and contacts
3 sites in 1 country.
Germany3 sites, 3 recruiting
- Recruiting
Sozialstiftung Bamberg, Klinik für Intergrative Medizin
Bamberg, Bavaria, 96049
Jost Langhorst, Prof., 0049951-503-11251, jost.langhorst@sozialstiftung-bamberg.de
Christine Uecker, 0049951-503-16932, christine.uecker@sozialstiftung-bamberg.de
- Recruiting
Evang. Kliniken Essen-Mitte, Klinik für Naturheilkunde & Integrative Medizin
Essen, 45276
Bettina Adler, 004920117425001, naturheilkunde@kem-med.com
- Recruiting
Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus Berlin, Standort Berlin-Wannsee
Wannsee, 14109
Miriam Rösner, 00493080505682, naturheilkunde.studien@immanuel.de
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Chronic Disease
- Being tested
- multimodal integrative naturopathic therapy concept
- 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
- Medical subject headings
- Chronic Disease, Irritable Bowel Syndrome, Colitis, Ulcerative, Crohn Disease, Rheumatic Diseases, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multimodal integrative naturopathic therapy conceptOther
Use of conventional medicine, naturopathic approaches and complementary medical therapy methods
| Study group | Role | What they receive |
|---|---|---|
| Chronic gastroenterological diseases - inpatient stay and day clinic | Irritable Bowel Syndrome, Crohn's disease, Ulcerative colitis Receives: Other: multimodal integrative naturopathic therapy concept | |
| Chronic Pain patients - inpatient stay and day clinic | Chronic pain syndrome, Rheumatism, Fibromyalgia Receives: Other: multimodal integrative naturopathic therapy concept | |
| Oncological diseases - day clinic | all kinds of oncological diseases Receives: Other: multimodal integrative naturopathic therapy concept | |
| post Covid syndrome - inpatient stay and day clinic | post Covid sydrome Receives: Other: multimodal integrative naturopathic therapy concept | |
| other diseases - day clinic | e.g. patients with cardiovascular diseases, chron. Pulmonary diseases, metabolic disorders and skin diseases, etc. Receives: Other: multimodal integrative naturopathic therapy concept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generic quality of life
SF-12, Short Form 36 Health Survey Questionnaire
Measured: week 0
Generic quality of life
SF-12, Short Form 36 Health Survey Questionnaire
Measured: week 2 (inpatient), week 10/11 (day clinic)
Generic quality of life
SF-12, Short Form 36 Health Survey Questionnaire
Measured: week 24 (inpatient), week 34/35 (day clinic)
Secondary outcomes (120)
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
Measured: 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
Measured: 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
Measured: week 24 (inpatient), week 34/35 (day clinic)
sex
identification of the gender
Measured: week 0
age
age in years
Measured: week 0
job
identification of the current job (questionnaire)
Measured: week 0
Educational level
identification of the educational level (questionnaire)
Measured: week 0
Expectation of the treatment (questionnaire)
patient's expectations regarding treatment
Measured: week 0
Use of complementary medicine/natural remedies (questionnaire)
medication and naturopathic approaches
Measured: week 0
Course of the disease (questionnaire)
diagnosis, treatment methods, medication
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: week 24 (inpatient stay)
Lactoferrin (chronic gastroenterological)
Determination of lactoferrin in the stool
Measured: week 0 (inpatient stay)
Lactoferrin (chronic gastroenterological)
Determination of lactoferrin in the stool
Measured: week 2 (inpatient stay)
Lactoferrin (chronic gastroenterological)
Determination of lactoferrin in the stool
Measured: week 24 (inpatient stay)
Calprotectin (chronic gastroenterological)
Determination of calprotectin in the stool
Measured: week 0 (inpatient stay)
Calprotectin (chronic gastroenterological)
Determination of calprotectinin the stool
Measured: week 2 (inpatient stay)
Calprotectin (chronic gastroenterological)
Determination of calprotectin in the stool
Measured: week 24 (inpatient stay)
PMN-Elastase (chronic gastroenterological)
Determination of PMN-Elastase in the stool
Measured: week 0 (inpatient stay)
PMN-Elastase (chronic gastroenterological)
Determination of PMN-Elastasethe in the stool
Measured: week 2 (inpatient stay)
PMN-Elastase (chronic gastroenterological)
Determination of PMN-Elastasethe in the stool
Measured: week 24 (inpatient stay)
Humanes Beta-Defensin (hBD-2) (chronic gastroenterological)
Determination of Humanes Beta-Defensin (hBD-2) in the stool
Measured: week 0 (inpatient stay)
Humanes Beta-Defensin (hBD-2) (chronic gastroenterological)
Determination of Humanes Beta-Defensin (hBD-2) in the stool
Measured: week 2 (inpatient stay)
Humanes Beta-Defensin (hBD-2) (chronic gastroenterological)
Determination of Humanes Beta-Defensin (hBD-2) in the stool
Measured: week 24 (inpatient stay)
Zonulin (chronic gastroenterological)
Determination of zonulin in the stool
Measured: week 0 (inpatient stay)
Zonulin (chronic gastroenterological)
Determination of zonulin in the stool
Measured: week 2 (inpatient stay)
Zonulin (chronic gastroenterological)
Determination of zonulin in the stool
Measured: week 24 (inpatient stay)
Alpha-Antitrypsin (chronic gastroenterological)
Determination of Alpha-Antitrypsin in the stool
Measured: week 0 (inpatient stay)
Alpha-Antitrypsin (chronic gastroenterological)
Determination of Alpha-Antitrypsin in the stool
Measured: week 2 (inpatient stay)
Alpha-Antitrypsin (chronic gastroenterological)
Determination of Alpha-Antitrypsin in the stool
Measured: week 24 (inpatient stay - follow-up)
CRP (C-reactive protein)
Determination of CRP in the blood
Measured: week 0 (inpatient stay)
CRP (C-reactive protein)
Determination of CRP in the blood
Measured: week 2 (inpatient stay)
BKS (blood cell sedimentation rate)
Determination of BKS in the blood
Measured: week 0 (inpatient stay)
BKS (blood cell sedimentation rate)
Determination of BKS in the blood
Measured: week 2 (inpatient stay)
I-FABP (chronic gastroenterological - substudy)
intestinal fatty-acid binding protein (blood)
Measured: inpatient stay (baseline)
I-FABP (chronic gastroenterological - substudy)
intestinal fatty-acid binding protein (blood)
Measured: inpatient stay (up to 24 weeks)
IgG/IgG4 (chronic gastroenterological - substudy)
immunoglobuline-G (blood)
Measured: inpatient stay (baseline)
IgG/IgG4 (chronic gastroenterological - substudy)
immunoglobuline-G (blood)
Measured: inpatient stay (up to 24 weeks)
IgE (chronic gastroenterological - substudy)
immunoglobuline-E (blood)
Measured: inpatient stay (baseline)
IgE (chronic gastroenterological - substudy)
immunoglobuline-E (blood)
Measured: inpatient stay (up to 24 weeks)
tissue samples (chronic gastroenterological - substudy)
Immunochemistry and gene expression analysis
Measured: inpatient stay (baseline)
tissue samples (chronic gastroenterological - substudy)
Immunochemistry and gene expression analysis
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: week 36 (day clinic)
monitoring of the main complaints (other diseases)
MYMOP: Measure Yourself Medical Outcome Profile
Measured: week 0 (day clinic)
monitoring of the main complaints (other diseases)
MYMOP: Measure Yourself Medical Outcome Profile
Measured: week 10 (day clinic)
monitoring of the main complaints (other diseases)
MYMOP: Measure Yourself Medical Outcome Profile
Measured: 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.
Measured: 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.
Measured: 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.
Measured: week 36 (day clinic)
Post-COVID autoantibody screening and T-cell activation assay (Elispot) of potentially reactivated latent pathogens
blood collection (substudy StaPoCo)
Measured: week 0 (inpatient stay)
Post-COVID autoantibody screening and T-cell activation assay (Elispot) of potentially reactivated latent pathogens
blood collection (substudy StaPoCo)
Measured: week 2 (inpatient stay)
Questionnaire to measure the severity of tiredness in fatiguing illnesses (Post-Covid-19 syndrome)
Chalder Fatigue Scale
Measured: week 0 (day clinic)
Questionnaire to measure the severity of tiredness in fatiguing illnesses (Post-Covid-19 syndrome)
Chalder Fatigue Scale
Measured: week 10 (day clinic)
Questionnaire to measure the severity of tiredness in fatiguing illnesses (Post-Covid-19 syndrome)
Chalder Fatigue Scale
Measured: week 36 (day clinic)
PSQI - Questionnaire which assesses sleep quality and disturbances (Post-Covid-19 Syndrome)
PSQI Pittsburgh Sleep Quality Index
Measured: week 0 (day clinic)
PSQI - Questionnaire which assesses sleep quality and disturbances (Post-Covid-19 Syndrome)
PSQI Pittsburgh Sleep Quality Index
Measured: week 11 (day clinic)
PSQI - Questionnaire which assesses sleep quality and disturbances (Post-Covid-19 Syndrome)
PSQI Pittsburgh Sleep Quality Index
Measured: 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.
Measured: 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.
Measured: 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.
Measured: week 24 (inpatient stay)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start4 Jan 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Collaborators
- Sozialstiftung Bamberg, Bavarian State Ministry of Health and Care, Charite University, Berlin, Germany, Kliniken Essen-Mitte
- Responsible party
- Principal investigator, Jost Langhorst, Universität Duisburg-Essen
- Investigators
- Jost Langhorst, Prof., Principal investigator, Sozialstiftung Bamberg, Klinik für Integrative Medizin und Naturheilkunde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04927403
- Sponsor's protocol ID
- 20068
- Acronym
- InteChron
- Status last verified
- Jan 2023
- First submitted
- 13 Apr 2021
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study in the Context of an Internal Medicine Clinic for Naturopathy and Integrative Medicine
- ClinicalTrials.gov ID
- NCT04927403
- Acronym / sponsor ID
- InteChron / 20068
- Conditions
- Chronic Disease
- Keywords
- irritable bowel syndrome, ulcerative colitis, Crohn's disease, pain patients, rheumatism, fibromyalgia syndrome, integrative medicine, naturopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Collaborators
- Sozialstiftung Bamberg, Bavarian State Ministry of Health and Care, Charite University, Berlin, Germany, Kliniken Essen-Mitte
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 16 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Chronic gastroenterological diseases - inpatient stay and day clinic | – | Other: multimodal integrative naturopathic therapy conceptIrritable Bowel Syndrome, Crohn's disease, Ulcerative colitis |
| Chronic Pain patients - inpatient stay and day clinic | – | Other: multimodal integrative naturopathic therapy conceptChronic pain syndrome, Rheumatism, Fibromyalgia |
| Oncological diseases - day clinic | – | Other: multimodal integrative naturopathic therapy conceptall kinds of oncological diseases |
| post Covid syndrome - inpatient stay and day clinic | – | Other: multimodal integrative naturopathic therapy conceptpost Covid sydrome |
| other diseases - day clinic | – | Other: multimodal integrative naturopathic therapy concepte.g. patients with cardiovascular diseases, chron. Pulmonary diseases, metabolic disorders and skin diseases, etc. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (2 listed)
- Patients at least 18 years of age
- signed declaration of consent
Key exclusion criteria (2 listed)
- Patients who have not reached the age of 18.
- Expected life expectancy < 6 months (oncology patients).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multimodal integrative naturopathic therapy conceptUse of conventional medicine, naturopathic approaches and complementary medical therapy methods | Other | Chronic Pain patients - inpatient stay and day clinic, Chronic gastroenterological diseases - inpatient stay and day clinic, Oncological diseases - day clinic, other diseases - day clinic, post Covid syndrome - inpatient stay and day clinic |
Primary outcome
Generic quality of life
Time frame: week 0
SF-12, Short Form 36 Health Survey Questionnaire
Generic quality of life
Time frame: week 2 (inpatient), week 10/11 (day clinic)
SF-12, Short Form 36 Health Survey Questionnaire
Generic quality of life
Time frame: week 24 (inpatient), week 34/35 (day clinic)
SF-12, Short Form 36 Health Survey Questionnaire
120 secondary outcomes
anxiety and depression
Time frame: week 0
anxiety and depression
Time frame: week 2 (inpatient), week 10/11 (day clinic)
anxiety and depression
Time frame: week 24 (inpatient), week 34/35 (day clinic)
sex
Time frame: week 0
age
Time frame: week 0
job
Time frame: week 0
Educational level
Time frame: week 0
Expectation of the treatment (questionnaire)
Time frame: week 0
Use of complementary medicine/natural remedies (questionnaire)
Time frame: week 0
Course of the disease (questionnaire)
Time frame: week 0
wellbeing/flourishing
Time frame: week 0 (inpatient stay)
wellbeing/flourishing
Time frame: week 2 (inpatient stay)
wellbeing/flourishing
Time frame: week 24 (inpatient stay)
Perceived stress
Time frame: week 0
Perceived stress
Time frame: week 2 (inpatient), week 10/11 (day clinic)
Perceived stress
Time frame: week 24 (inpatient), week 34/35 (day clinic)
disease activity (irritable bowel syndrome)
Time frame: week 0
disease activity (irritable bowel syndrome)
Time frame: week 2 (inpatient), week 10/11 (day clinic)
disease activity (irritable bowel syndrome)
Time frame: week 24 (inpatient), week 34/35 (day clinic)
diseasespecific quality of life (irritable bowel syndrome)
Time frame: week 0
diseasespecific quality of life (irritable bowel syndrome)
Time frame: week 2 (inpatient), week 10/11 (day clinic)
diseasespecific quality of life (irritable bowel syndrome)
Time frame: week 24 (inpatient), week 34/35 (day clinic)
Partial Mayo Score, disease activity (ulcerative colitis)
Time frame: week 0
Partial Mayo Score, disease activity (ulcerative colitis)
Time frame: week 2 (inpatient), week 10/11 (day clinic)
Partial Mayo Score, disease activity (ulcerative colitis)
Time frame: week 24 (inpatient), week 34/35 (day clinic)
diseasespecific quality of life (ulcerative colitis)
Time frame: week 0
diseasespecific quality of life (ulcerative colitis)
Time frame: week 2 (inpatient), week 10/11 (day clinic)
diseasespecific quality of life (ulcerative colitis)
Time frame: week 24 (inpatient), week 34/35 (day clinic)
disease activity (Crohn's disease)
Time frame: week 0
disease activity (Crohn's disease)
Time frame: week 2 (inpatient), week 10/11 (day clinic)
disease activity (Crohn's disease)
Time frame: week 24 (inpatient), week 34/35 (day clinic)
diseasespecific quality of life (Crohn's disease)
Time frame: week 0
diseasespecific quality of life (Crohn's disease)
Time frame: week 2 (inpatient), week 10/11 (day clinic)
diseasespecific quality of life (Crohn's disease)
Time frame: week 24 (inpatient), week 34/35 (day clinic)
disease activity (pain patients)
Time frame: week 0
disease activity (pain patients)
Time frame: week 2 (inpatient), week 10/11 (day clinic)
disease activity (pain patients)
Time frame: week 24 (inpatient), week 34/35 (day clinic)
diseasespecific quality of life (pain patients)
Time frame: week 0
diseasespecific quality of life (pain patients)
Time frame: week 2 (inpatient), week 10/11 (day clinic)
diseasespecific quality of life (pain patients)
Time frame: week 24 (inpatient), week 34/35 (day clinic)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jost Langhorst, Prof. principal investigator
Sozialstiftung Bamberg, Klinik für Integrative Medizin und Naturheilkunde
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Disease, run by Universität Duisburg-Essen at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jost Langhorst, Prof. (0049951-503-11251, jost.langhorst@sozialstiftung-bamberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generic quality of life (time frame: week 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.