Development of the SC-IBD Self-Care Measurement Scale
Observational · No treatment assigned · 1 site · Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Inflammatory Bowel Diseases, Ulcerative Colitis and Crohn Disease. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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.
Plus 4 more requirement(s). There are also 6 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 275 participants are expected to take part.
- Start date: 2026-10-30 (planned).
- Main results expected around 2027-10-30 (estimate from the record).
- 1 study site listed in Italy.
Main thing being measured
- Psychometric Validation of the SC-IBD Scale (Baseline to 3 months)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Inflammatory Bowel Diseases; Ulcerative Colitis; Crohn Disease |
| Lead sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Enrollment | 275 (estimated) |
| Start date | 2026-10-30 |
| Primary completion (est.) | 2027-10-30 |
| First posted | 2026-03-27 |
| Last updated | 2026-09-21 |
| Official title | Development of a Self-Care Measurement Scale for Patients With Inflammatory Bowel Disease (IBD) and Its Application in an Outpatient Setting |
| ClinicalTrials.gov ID | NCT07494227 |
Interventions
- None listed
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Policlinico Universitario A. Gemelli IRCCS | Roma, RM | Italy |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.