Developing a Self-Care Measurement Scale for People With Inflammatory Bowel Disease
Develops a questionnaire to measure self-care in adults with ulcerative colitis or Crohn disease.
Key facts
- Who runs it
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Where
- Roma, ItalySee the site
- Trial code
- Registry title
- Development of the SC-IBD Self-Care Measurement Scale
- Status
- Not yet recruiting
- People taking part
- 275 people, planned
- Started
- 30 Oct 2026
- Expected to end
- 30 Oct 2028
- Type of study
- Observational
- Record updated
- 21 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who have had Crohn's disease or ulcerative colitis for at least 12 months and are followed in an outpatient clinic. It aims to build a self-care scale.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Crohn's disease or ulcerative colitis, diagnosed at least 12 months ago, followed as an outpatient
Main reasons for not taking part
- Under 18 years old
- Significant cognitive impairment, such as dementia
- Not enough understanding of Italian
- Severe psychiatric disorders that may limit taking part
- Severe clinical conditions that prevent interviews or filling in questionnaires
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- 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
Who cannot take part
- Significant cognitive impairment (e.g., dementia) that may limit participation
- Severe psychiatric disorders that may compromise participation
- Severe clinical conditions preventing participation in interviews or questionnaire completion
- Age younger than 18 years
- Insufficient comprehension of the Italian language
- Refusal to sign the informed consent form
Where in Italy
- Fondazione Policlinico Universitario A. Gemelli IRCCSRoma, ItalyContact: Daniele Napolitano, RNNo longer taking part
About the trial
What the trial wants to find out
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Development of a Self-Care Measurement Scale for Patients With Inflammatory Bowel Disease (IBD) and Its Application in an Outpatient Setting
- Plain-language title
- Developing a Self-Care Measurement Scale for People With Inflammatory Bowel DiseaseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 21 September 2026