Development of the SC-IBD Self-Care Measurement Scale

NCT07494227 | Not Yet Recruiting

• 1 other identifier: 8158 - SC-IBD
• Study Type: observational
• Target: 275
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inflammatory Bowel Diseases; Ulcerative Colitis; Crohn Disease

Outcome Measures

Primary Outcomes (1)

• Psychometric Validation of the SC-IBD Scale

  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.

  Baseline to 3 months

Secondary Outcomes (6)

• Qualitative Themes of Self-Care in Patients with IBD

  Baseline

• Psychological Distress Measured by DASS-21

  Baseline

• Health-Related Quality of Life Assessed by SF-12

  Baseline

• Illness Perception Measured by BIPQ

  Baseline

• Perceived Disease Control Measured by IBD-Control

  Baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult outpatients diagnosed with Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) followed at the IBD outpatient clinic of the Fondazione Policlinico Universitario A. Gemelli IRCCS and affiliated satellite centers. Participants must have received an IBD diagnosis for at least 12 months, be able to read and speak Italian, and be willing to participate in either the qualitative or quantitative phase of the study. A total of 275 patients will be enrolled.

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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, RM, 00168, Italy

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Daniele Napolitano, RN

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniele Napolitano, RN

CONTACT

+393382650440; daniele.napolitano@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: March 27, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)