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Not Yet Recruiting 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07494227). StuddyBuddy aggregates publicly available trial information.