Development of the SC-IBD Self-Care Measurement Scale

Starting soon

Conditions studied: Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease

In brief

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.

Key facts

Study ID

NCT07494227

Run by

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

People needed

275

Starts

2026-04-30

Expected to finish

2028-04-30

Last updated by the study team

2026-03-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Fondazione Policlinico Universitario A. Gemelli IRCCS — Roma, RM, Italy

Full record on ClinicalTrials.gov

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