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NCT Number: NCT07494227

Development of the SC-IBD Self-Care Measurement Scale

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, RM, 00168, Italy

Location contact

Daniele Napolitano, RN

CONTACT

[email protected]

+393382650440

Daniele Napolitano, RN

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Psychometric Validation of the SC-IBD Scale

    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.

Secondary outcomes

  1. Qualitative Themes of Self-Care in Patients with IBD

    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.

  2. Psychological Distress Measured by DASS-21

    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.

  3. Health-Related Quality of Life Assessed by SF-12

    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.

  4. Illness Perception Measured by BIPQ

    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.

  5. Perceived Disease Control Measured by IBD-Control

    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.

  6. Food Literacy Assessed by the Short Food Literacy Questionnaire

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniele Napolitano, RN

CONTACT

[email protected]

+393382650440

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Development of a Self-Care Measurement Scale for Patients With Inflammatory Bowel Disease (IBD) and Its Application in an Outpatient Setting

Acronym: SC-IBD

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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