IBD-PODCAST GERMANY Proportion of Inadequate Disease Control And Strategy of Treatment in IBD

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00027278

Enrollment

500

Registered

2022-02-10

Start date

2022-04-08

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K51 K50

Interventions

Group 1: This is a non-interventional, multicenter observational study with a retrospective cross-sectional assessment focused on the collection of real-world data on the treatment situation of patien

Eligibility

Sex/Gender

All

Age

19 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients are eligible to participate in this observational study if they meet the following requirements: - = 19 years at the time of study entry - Confirmed diagnosis of UC or CD = 1 year prior to study entry, including site documentation - Ready and able to provide informed consent - Ready and able to read, understand and answer patient study materials

Exclusion criteria

Exclusion criteria: Patients are not eligible to participate in this observational study if: - documentation in the medical file < 12 months - current study drug/non-approved device/intervention treatment - diagnosis of IBDU (non-classified IBD) - history of proctocolectomy

Design outcomes

Primary

Measure	Time frame
- Insufficient disease control (yes/no) of Crohn's disease (CD) at index date, defined as patients with one or more red flags indicating insufficient disease control - Insufficient disease control (yes/no) of ulcerative colitis (UC) at index date, defined as patients with one or more red flags indicating insufficient disease control - short inflammatory bowel disease questionnaire (SIBDQ) scores in CD patients inadequately or adequately controlled at index date - SIBDQ scores in UC patients inadequately or adequately controlled at index date	—

Measure

Time frame

- Insufficient disease control (yes/no) of Crohn's disease (CD) at index date, defined as patients with one or more red flags indicating insufficient disease control - Insufficient disease control (yes/no) of ulcerative colitis (UC) at index date, defined as patients with one or more red flags indicating insufficient disease control - short inflammatory bowel disease questionnaire (SIBDQ) scores in CD patients inadequately or adequately controlled at index date - SIBDQ scores in UC patients inadequately or adequately controlled at index date

—

Secondary

Measure	Time frame
1. CD/UC-associated Health Care Resource Utilization (HCRU) in the 12 months prior to the index date - number of outpatient visits (by reason and subject area consulted) - number of emergency room visits - number and duration of hospital stays (by reason of elective/non-elective) - number and type of surgery - number of days off work due to illness - number and type of TIM (targeted immunomodulators) therapies in CD/UC 2. Assessment of the patient's self-reported inadequate disease control at index date (yes/no) 3. Number and distribution of reasons for the patient's self-reported inadequate disease control at index date 4. Duration of the patient's self-reported inadequate disease control at index date 5. Assessment of the physician's reported inadequate disease control at index date (yes/no) 6. Number and distribution of reasons for physician's reported adequate/inadequate disease control at index date 7. Duration of physician's reported inadequate disease control at index date 8. Number, dose and type of corticosteroids prescribed in 12 months prior to index date 9. Number of TIM 10. Sequence of TIM from CD/UC diagnosis to index date 11. Type of treatment adjustments made on the index date 12. type of diagnostic measures planned carried out on the index date 13. Work Productivity and Activity Impairment (WPAI) Index date score 14. Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Index date score 15. Co-morbidities	—

Measure

Time frame

1. CD/UC-associated Health Care Resource Utilization (HCRU) in the 12 months prior to the index date - number of outpatient visits (by reason and subject area consulted) - number of emergency room visits - number and duration of hospital stays (by reason of elective/non-elective) - number and type of surgery - number of days off work due to illness - number and type of TIM (targeted immunomodulators) therapies in CD/UC 2. Assessment of the patient's self-reported inadequate disease control at index date (yes/no) 3. Number and distribution of reasons for the patient's self-reported inadequate disease control at index date 4. Duration of the patient's self-reported inadequate disease control at index date 5. Assessment of the physician's reported inadequate disease control at index date (yes/no) 6. Number and distribution of reasons for physician's reported adequate/inadequate disease control at index date 7. Duration of physician's reported inadequate disease control at index date 8. Number, dose and type of corticosteroids prescribed in 12 months prior to index date 9. Number of TIM 10. Sequence of TIM from CD/UC diagnosis to index date 11. Type of treatment adjustments made on the index date 12. type of diagnostic measures planned carried out on the index date 13. Work Productivity and Activity Impairment (WPAI) Index date score 14. Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Index date score 15. Co-morbidities

—

Countries

Germany

Contacts

Public ContactAxel Dignass

AGAPLESION MARKUS KRANKENHAUS Medizinische Klinik

markus.fdk@agaplesion.de+49 (0) 6995 33 - 0

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026