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NCT07494227
Development of the SC-IBD Self-Care Measurement Scale
Conditions: Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 275
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Location: Fondazione Policlinico Universitario A. Gemelli IRCCS Roma RM
Summary
This study aims to develop and validate a disease-specific self-care measurement scale for patients with Inflammatory Bowel Disease (IBD). The research follows a sequential mixed-methods design: a qualitative phase to identify key self-care concepts, followed by a quantitative phase to test the psychometric properties of the newly developed SC-IBD scale in an outpatient population.
Eligibility Criteria
Inclusion Criteria:
* Voluntary willingness to participate in the study.
* Diagnosis of Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) for at least 12 months.
* Follow-up in outpatient setting.
* Age 18 years or older.
* Ability to read and speak Italian.
* Ability to understand the study procedures.
* Signed informed consent.
Exclusion Criteria:
* Age younger than 18 years.
* Significant cognitive impairment (e.g., dementia) that may limit participation.
* Insufficient comprehension of the Italian language.
* Severe psychiatric disorders that may compromise participation.
* Severe clinical conditions preventing participation in interviews or questionnaire completion.
* Refusal to sign the informed consent form.
Source: ClinicalTrials.gov (NCT07494227). StuddyBuddy aggregates publicly available trial information.