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NCT06015789: IBD-Self
Self-care in Patients Affected by Inflammatory Bowel Disease and Caregivers' Contribution to Self-care
trial testing Questionnaire in Inflammatory Bowel Diseases in 250 participants. Completed in 30 April 2025.
1 October 2024
Quick facts
| Lead sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 250 |
| Start date | 4 September 2023 |
| Primary completion | 1 October 2024 |
| Estimated completion | 30 April 2025 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Questionnaire
Conditions studied
- Inflammatory Bowel Diseases — all drugs for Inflammatory Bowel Diseases →
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Who can join
18 and older, any sex, with Inflammatory Bowel Diseases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The Inflammatory Bowel Disease (IBD) is a chronic inflammatory disease of the gastrointestinal tract including Crohn's disease and Ulcerative Colitis. The course of IBD is frequently progressive and can be hardly predictable, with sudden exacerbations of intestinal symptoms. Epidemiological studies have shown that IBD has an increasing prevalence to reach 10 million people in 2030. These diseases require frequent interactions between patients and the healthcare system, or symptom management with continuous therapies, gastroenterological visits, surgery, contacts for resolution of urgent symptoms from telephone and email, access to the emergency, hospitalizations, nutritional counseling, psychological interventions and follow-up controls. An IBD can completely disrupt a family's ability to function normally and often imposes a strain on family members' relationships. In the model of self-care in chronic diseases, according to Riegel's "Middle Range Theory", there are external factors, predictive factors that can influence and limit the patient's attitude and therefore his self-esteem, the ability to implement decision-making behaviors to improve and increase his self-care. There are also factors that influence a person's self-care decisions: the particular caregivers. In this process, the role of the caregiver and the dyad he establishes with the patient can influence the whole process of self-confidence and self-care. The objectives of the study are to investigate and describe self-care in patients with IBD and how their caregivers in dyadic interaction can contribute.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Self-care in patients affected by inflammatory bowel disease and caregiver contribution to self-care (IBD-SELF): a protocol for a longitudinal observational study.
Napolitano D, Vellone E, Iovino P, Scaldaferri F, et al · · 2024 · cited 10× · PMID 39209770 · DOI 10.1136/bmjgast-2024-001510 -
Resilience and Self-Care in Patients with Inflammatory Bowel Disease: A Multicentre Cross-Sectional Study in Outpatient Settings.
Napolitano D, Bozzetti M, Lo Cascio A, De Stefano G, et al · · 2025 · cited 3× · PMID 40507629 · DOI 10.3390/jcm14113868 -
Validity and Reliability of the Self-Care of Chronic Illness Inventory in Patients Living With Inflammatory Bowel Disease.
Napolitano D, Biagioli V, Bartoli D, Cilluffo S, et al · · 2025 · cited 3× · PMID 40033448 · DOI 10.1111/jocn.17712 -
Exploring the Mediating Role of Self-Efficacy in the Relationship Between Caregiver Contribution and Resilience in Inflammatory Bowel Disease.
Bozzetti M, Marcomini I, Lo Cascio A, Magurano MR, et al · · 2025 · cited 2× · PMID 41153171 · DOI 10.3390/bs15101381 -
Exploring nurse-patient mutuality in inflammatory bowel disease: a multicenter cross-sectional study.
Napolitano D, Cilluffo S, Marini A, Lusignani M. · · 2025 · cited 1× · PMID 41387861 · DOI 10.1186/s12912-025-04215-1 -
Predictors of self-care among informal caregivers of patients with inflammatory bowel disease: a cross-sectional study.
Napolitano D, Iovino P, Benedetti F, Dorri N, et al · · 2026 · PMID 42164612 · DOI 10.20524/aog.2026.1055 -
Caregiver Contribution to Self-Care in Adults with Inflammatory Bowel Disease: A Cross-Sectional Multicenter Study.
Napolitano D, Lo Cascio A, Bozzetti M, Benedetti F, et al · · 2026 · PMID 42042637 · DOI 10.3390/nursrep16040110 -
Validity and Reliability of the Caregiver Contribution to Self-Care of Chronic Illness Inventory in Patients With Inflammatory Bowel Disease.
Cilluffo S, Bartoli D, Napolitano D, Biagioli V, et al · · 2026 · PMID 42022938 · DOI 10.1002/jgh3.70340
Verify or expand the search:
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06015789 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Last refreshed: 2 July 2025
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