Ireland
--:--IST
Starting soon Observational

Development of the SC-IBD Self-Care Measurement Scale

NCT07494227 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2026-10-30
Last updated
2026-09-21

Condition(s) studied

Inflammatory Bowel DiseasesUlcerative ColitisCrohn Disease

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Psychometric Validation of the SC-IBD Scale — Baseline to 3 months
    Assessment of the psychometric properties of the SC-IBD scale, including internal consistency (e.g., McDonald's Omega), construct validity (exploratory and confirmatory factor analyses), content validity, convergent and divergent validity, and test-retest reliability. Analyses will determine whether the scale reliably and validly measures self-care behaviors in patients with Inflammatory Bowel Disease.

Trial sites (1)

FacilityCityRegionStatus
Fondazione Policlinico Universitario A. Gemelli IRCCS Roma RM
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07494227 on ClinicalTrials.gov ↗ ← All trials in Italy