Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, RM, 00168, Italy
Location contact
Daniele Napolitano, RN
CONTACT
Daniele Napolitano, RN
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07494227
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Roma, RM, 00168, Italy
Daniele Napolitano, RN
CONTACT
Daniele Napolitano, RN
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Other
Development of a Self-Care Measurement Scale for Patients With Inflammatory Bowel Disease (IBD) and Its Application in an Outpatient Setting
Acronym: SC-IBD
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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