Clinical trial · Interventional
Are Rates of Colectomies, Resections, Mortalities and Cancer Reduced by Home Monitoring of IBD Patients ?
Are Rates of Colectomies, Resections, Mortalities and Cancer Reduced by Home Monitoring of IBD Patients Tightly on Demand or Every 3 Months by Fecal Calprotectin and Disease Activity?
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a side protocol/extension of 10 years of ClinicalTrials.gov ID: NCT02492555. The purpose of this study is to determine if the IBD patients doing home monitoring (screening themselves on demand (OD) or every 3 months) have relative reduced rates of colectomies, resections, mortalities and cancer after 11 years of web monitoring. The IBD patients are self-monitoring by web apps consisting of a short disease activity questionnaire (DA) and fecal calprotectin (FC) on any smart phone.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Inflammatory Bowel Diseases | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| At Home Screening procedure every 3 months | Behavioral | — | UNRESOLVED |
| At Home Screening procedure On demand | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Every 3 months
- description
- screening every 3rd month: (home monitoring: FC and DA)
- interventionNames
- Behavioral: At Home Screening procedure every 3 months
- type
- ACTIVE_COMPARATOR
- label
- On demand
- description
- screening On demand: (home monitoring: FC and DA)
- interventionNames
- Behavioral: At Home Screening procedure On demand
Primary outcomes (4)
- measure
- colectomies
- timeFrame
- 11 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * IBD patients in remission, SCCAI ≤ 2 (Simple Clinical Colitis Activity Index )) or HBI \< 5 (Harvey \& Bradshaw Activity Index ) or in mild to moderate disease activity ( SCCAI 3-4, HBI \< 16). IBD patients who can read, speak and understand Danish. IBD patients that can take advantage of the Internet and wireless network. Exclusion Criteria: * IBD patients with severe disease activity HB \> 16 SCCAI ≥ 5. IBD patients with social, medical or psychological issues of a more complex character. IBD patients with particularly complex issues such as drug and alcohol problems, severe mental / psychiatric disorders and / or serious social impact.IBD patients who cannot attend due language barrier or cognitive disorder.
References
Publications (0)
Data not yet available