Adolescents and young adults (AYA) with quiescent inflammatory bowel disease (IBD), Crohn's disease (CD) and ulcerative colitis (UC) Digestive System
Conditions
Interventions
On completion of the baseline Information Report Form (IRF), each recruited participant will be randomly allocated to either the treatment or control arm . A data analyst not actively involved in the
Sponsors
Bambino Gesù Children's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. IBD patients aged between 11 and 21 years old 2. Able to read, write, and speak Italian language 3. Without expectation of surgery in the upcoming 3 months
Exclusion criteria
Exclusion criteria: 1. Severe cognitive, neurological and psychiatric co-occurring conditions that could interfere with patients' participation 2. Inability to provide informed consent and receiving psychological treatment or psychotropic medication at the time of recruitment (or other psychotropic medication <2 years before recruitment)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Remission maintenance: the proportion of participants with steroid-free remission defined by disease activity and measured using the Pediatric Crohn's Disease Activity Index (PCDAI) score for patients with CD and the Pediatric Ulcerative Colitis Activity Index (PUCAI) score for those with UC from baseline to week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Healthcare utilization measured using the frequency of hospitalizations recorded in patient medical records from baseline to week 52 2. Adherence to medication measured by quantifying adherent and non-adherent participants recorded in patient medical records from baseline to week 52 | — |
Countries
Italy
Contacts
Public ContactFrancesco Milo
Outcome results
None listed