K50 K51
Conditions
Interventions
Group 1: Regular monitoring of remission using a calprotectin stool self-test every 3 months for 12 months
Group 2: Initially, monthly calprotectin stool self-tests for 6 months, followed by regular m
Sponsors
BMVg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Soldier with a remaining service period of >13 months at enrollment - Diagnosis of IBD for =6 months - Clinical remission according to STRIDE criteria: Crohn’s disease (CD): Harvey-Bradshaw Index (HBI) 1 - Participants may either be without IBD-specific medication or must be on a stable remission-maintaining therapy (e.g., mesalazine, thiopurines, biologics) for =3 months - Stable treatment with no planned changes to IBD therapy - No planned IBD-related surgery - Smartphone compatible with the IBDoc® App (BÜHLMANN) - Cooling option for the IBDoc® test
Exclusion criteria
Exclusion criteria: - Penetrating Crohn’s disease, active perianal disease in Crohn’s disease (e.g., fistulas or encapsulated abscesses), symptomatic stricture in Crohn’s disease - Baseline calprotectin level at enrollment (time point 0) > 250 µg/g - Planned or required IBD-related surgery during the study period - Premature discharge from military service in the Bundeswehr, resulting in the loss of free military healthcare and loss of follow-up feasibility - Use of systemic corticosteroids (>10 mg prednisolone equivalent per day) or a change in immunosuppressive therapy within the last 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1 (0–6 months): Acceptance (Equivalence Test) Assessed after 6 months using a questionnaire with an 8-item 5-point Likert scale. Phase 2 (7–12 months): Adherence Assessed after 12 months (as well as after 6 months) by documenting the number of completed stool tests and the number of answered PRO2 questionnaires at each designated time point | — |
Secondary
| Measure | Time frame |
|---|---|
| - Usability is assessed using a questionnaire based on the System Usability Score (SUS), a validated and standardized ten-item measure of user-friendliness. - Need for intervention is documented by recording medical measures such as contact with the study center, disease flares, performed endoscopies, or imaging procedures | — |
Countries
Germany
Contacts
Public ContactTrixi Braasch
Bundeswehrkrankenhaus Berlin
Outcome results
None listed