ClinicalTrials.gov
Cure8 trial brief
Why This Matters
A validated, disease-specific self-care scale could help measure and track self-management behaviors that affect daily life and clinical outcomes for people with IBD, and support research and clinical care focused on self-management needs.
Who Should Pay Attention
Adults with Crohn’s disease or ulcerative colitis; IBD clinicians and researchers interested in patient-reported outcomes and self-care.
Study Snapshot
Story typeClinical Reference
Evidence typeClinical trial
Enrollment275 participants
Study statusNot_yet_recruiting
Source depthTrial registry record
What To Know
This is a registered observational study aiming to develop and validate the SC-IBD, a disease-specific self-care measurement scale for adults with inflammatory bowel disease (Crohn’s disease or ulcerative colitis).
The project uses a sequential exploratory mixed-methods design: interviews with outpatients will inform item generation and content validity, followed by psychometric testing (construct validity, internal consistency, test–retest reliability) of the preliminary scale in a larger outpatient cohort.
Validated instruments such as DASS-21, SF-12, BIPQ, IBD-Control, and a food literacy questionnaire will be used for convergent and divergent validity and to describe related psychological and behavioral correlates.
The study is observational and not yet recruiting at a single site in Rome, Italy, plans to enroll about 275 adults with IBD who have had the diagnosis for at least 12 months, and requires participants to read Italian.
Primary outcome is psychometric validation of the SC-IBD over baseline to 3 months; no clinical interventions or treatment changes are being tested.
Keep In Mind
Registry entry describes planned methods and outcomes but contains no study results. The scale development and validation will be conducted in Italian-speaking outpatient populations, which may limit immediate applicability elsewhere.
Source Details
Review the original publication for the complete reporting, methods, and context.
Clinical trial
Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
Trial IDNCT07494227
Study typeObservational
Enrollment275 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedSep 21, 2026, 12:00 AM
Content availableTrial registry record
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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