chronic inflammatory diseases M05 M06 M07 M45 L40.0 K50 K51
Conditions
Interventions
Group 1: intervention group
Consultation hours after approx. 4 weeks, 3 and 9 months are carried out by the MFA, consultation hours at the beginning of the study, after 6 and 12 months by the physicia
Sponsors
Medizinische Hochschule Hannover
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Written consent to participate in the health care research study 2. Age: = 18 years 3. Patients with chronic inflammatory diseases in the fields of gastroenterology, rheumatology, dermatology with a doctor’s confirmed diagnosis of a chronic inflammatory disease at the start of therapy, change or escalation of therapy: Rheumatology: patients with RA or SpA or PsA (ICD M05 or M06 each with subgroups or M07.0-M07.39, M45.0x) Dermatology: Patients with PsO: ICD L40.0 with L40.7 Gastroenterology: Patients with IBD (ulcerative colitis or Crohn's disease): ICD K50 or K51 with subgroups
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. It is foreseeable that the patient will not be available for a one-year observation period. 2. Insufficient knowledge of German 3. Serious comorbidities at the discretion of the treating physician 4. Lack of ability to consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objective: Patients with chronic inflammatory diseases (in the fields of gastroenterology, rheumatology and dermatology) who attend MFA consultation have at least as high health-related quality of life as patients in standard care. Primary Endpoint: The primary endpoint is defined as the difference between the intervention group (IG) and the control group (KG) in terms of health-related quality of life after 12 months (measured with the European Quality of Life 5 Dimensions and 3 Levels (EQ-5D-3L) and the Visual Analog Scale (VAS)). | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-specific and general survey instruments are available for the collection of secondary endpoints. The secondary endpoints are analyzed with regard to the difference between the intervention group and the control group at different points in time. 1. Determination of the change in disease-related quality of life over a period of 12 months in the area of gastroenterology and dermatology. Measured at baseline (t0), after 6 and 12 months using the Inflammatory Bowel Disease Questionnaire (IBDQ) and the Dermatological Quality of Life Index (DLQI). 2. Determination of the change in disease activity over a period of 12 months in the three disciplines. Measured at baseline (t0), after 1, 3, 6, 9 and 12 months with the Harvey-Bradshaw Index (HBI) for Crohn's disease, the Partial Mayo Score (PMS) for ulcerative colitis, the Disease Activity Score (DAS28 or DAS44 ) for RA or PsA, the Bath Ankylosing Spondylitis Activity Score (BASDAI) for SpA and the Psoriasis Area and Severity Index (PASI) for psoriasis. 3. Determination of the change in functional capacity over a period of 12 months in rheumatology. Measured at baseline (t0), after 6 and 12 months using the Hanover functional questionnaire (FFbH). 4. Determination of the change in coping with illness in the three disciplines. Measured at baseline (t0), after 6 and 12 months with the Brief COPE. 5. Determination of the change in the severity of anxious and depressive symptoms over a period of 12 months in the three disciplines. Measured at baseline (t0), after 6 and 12 months using the Hospital Anxiety and Depression Scale (HADS-D). 6. Determination of the change in the ability to work over the period of 12 months in the three disciplines. Measured at baseline (t0), after 6 and 12 months using the Work Productivity and Activity Impairment Questionnaire (WPAI). 7. Determination of the change in the use of health services over the period of 12 months in the three disciplines. Measured at baseline (t0) and | — |
Countries
Germany
Contacts
Public ContactKirsten Hoeper
Medizinische Hochschule Hannover
Outcome results
None listed