Development of the SC-IBD Self-Care Measurement Scale

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.

Primary outcomes

• 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.

Secondary outcomes

• Qualitative Themes of Self-Care in Patients with IBD [Baseline]: Qualitative analysis of semi-structured interviews to identify recurring themes and patterns of self-care behaviors across the dimensions of self-care maintenance, monitoring, and management, based on the Middle-Range Theory of Self-Care of Chronic Illness. Findings inform the generation and refinement of SC-IBD scale items.
• Psychological Distress Measured by DASS-21 [Baseline]: Assessment of depression, anxiety, and stress using the DASS-21 validated Italian version. Scores will be used to evaluate convergent and divergent validity of the SC-IBD scale and explore associations between self-care and psychological distress.
• Health-Related Quality of Life Assessed by SF-12 [Baseline]: Measurement of physical and mental health components through the SF-12 questionnaire to evaluate relationships between self-care behaviors and quality of life, supporting the SC-IBD validity analysis.
• Illness Perception Measured by BIPQ [Baseline]: Evaluation of cognitive and emotional representations of illness using the Brief Illness Perception Questionnaire. Correlations with the SC-IBD scale will be used to assess construct validity.
• Perceived Disease Control Measured by IBD-Control [Baseline]: Assessment of patient-reported control of IBD using the validated Italian version of the IBD-Control questionnaire (extended form with VAS). Used to explore relationships between perceived disease control and self-care behaviors.
• Food Literacy Assessed by the Short Food Literacy Questionnaire [Baseline]: Measurement of food literacy using the SFLQ (Italian version). Results will help determine whether food literacy acts as a determinant or moderator of self-care in patients with IBD and evaluate convergent validity of the SC-IBD scale.

Sex: All, ages: 18 Years to any

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.

• Daniele Napolitano, RN, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS