Development of the SC-IBD Self-Care Measurement Scale

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Not yet enrolling

Conditions: Ulcerative Colitis; Inflammatory Bowel Diseases; Crohn Disease

Study type: Observational

Funder types: Other

Identifiers

NCT07494227

8158 - SC-IBD

Details and patient eligibility

About

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.

Full description

This study is designed to develop and validate the SC-IBD scale, a disease-specific instrument for measuring self-care in patients with Inflammatory Bowel Disease (IBD). The project uses a sequential exploratory mixed-methods design.

In the qualitative phase, semi-structured interviews will be conducted with outpatients diagnosed with IBD to explore their experiences of self-care across the three theoretical dimensions described in the Middle-Range Theory of Self-Care of Chronic Illness: maintenance, monitoring, and management. The qualitative findings will inform item generation and content validity assessment through a multidisciplinary expert panel.

The quantitative phase will include the administration of the preliminary SC-IBD scale to an outpatient cohort in order to evaluate its psychometric properties, including construct validity, internal consistency, and test-retest reliability. Additional validated instruments (DASS-21, SF-12, BIPQ, IBD-Control, and the Short Food Literacy Questionnaire) will be used to assess convergent and divergent validity and to describe relevant psychological, clinical and behavioral correlates of self-care in IBD.

The ultimate goal of the study is to produce a reliable, valid, and clinically useful tool for assessing self-care behaviors in individuals living with IBD, supporting both research and clinical practice.

Enrollment: 275 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.