Table 1.
Schedule of enrolment, interventions and assessments
| Study-related procedures | Enrolment | Intervention period | Follow-up period | Close-out | ||
| Visits Patient’s age |
Visit 0 16.75–17 years |
Visit 1 17 years±30 days |
Visit 2–3–4* | Visit 5 | Visit 6–7–8* | Visit 9 19 years±30 days |
| Enrolment | ||||||
| Eligibility screen | x | |||||
| Informed consent | x | |||||
| Allocation | x | |||||
| Interventions | ||||||
| Intervention group | PGE | PGE+AGE | PGE+AGE | AGE | AGE | AGE |
| Control group | PGE | PGE | PGE | AGE | AGE | AGE |
| Assessments | ||||||
| Demographic data | x | x | x | |||
| Medical history | x | |||||
| Physical examination† | x | x | x | x | x | |
| Body height and weight | x | x | x | x | x | |
| Actual medications | x | x | x | x | x | |
| Adverse events | x | x | x | x | x | |
| Disease activity (PUCAI/PCDAI) | x | x | x | x | x | |
| Disease activity (Mayo/CDAI/perianal CDAI) | x | x | x | x | x | |
| Healthcare utilisation‡ | x | x | x | x | x | |
| Serum sample§ | x | x | x | x | x | |
| Stool sample¶ | x | x | x | |||
| Questionnaires | ||||||
| Self-efficacy (IBDSES-A) | x | x | x | |||
| Transition readiness (TRAQ) | x | x | x | |||
| Transition readiness (STARx-adolescent version) | x | x | x | |||
| Transition readiness (STARx-parent version) | x | x | x | |||
| HRQoL (IMPACT-III) | x | x | x** | x | ||
| Patient satisfaction (CACHE) | x | x | x | |||
| Medication adherence (MARS-5) | x | x | x | |||
X = scheduled measurements.
*During the study, visits are held in every three months (±30 days).
†First visit: complete physical examination; further visits: symptom-oriented physical.
‡IBD-related healthcare utilisation (considering the last 3 months): 1. number of unscheduled visits at the caregiver gastroenterologist; 2. number of unplanned/unscheduled visits at the emergency department; 3. number of scheduled and urgent imaging; 4. number of scheduled and urgent endoscopies; 5. number and type of surgical interventions; 6. number of IBD-related hospital admissions; 7. length of hospitalisation.
§Determination of laboratory parameters (haematology, biochemistry, inflammatory markers).
¶Determination of stool calprotectin.
**HRQoL will be measured at visit 7.
AGE, medical visit with the adult gastroenterologist; CDAI, Crohn Disease Activity Index; HRQoL, health-related quality of life; IBD, inflammatory bowel disease; IBDSES-A, IBD Self-Efficacy Scale for adolescents and young adults; MARS-5, Medical Adherence Report scale; PCDAI, Paediatric Crohn’s Disease Activity Index; PGE, medical visit with the pediatric gastroenterologist; PGE + AGE, joint visit with the attendance of both pediatric and adult gastroenterologists; PUCAI, Paediatric Ulcerative Colitis Activity Index; STARx-adolescent, STARx Transition Readiness Questionnaire (Adolescent Version); STARx-parent, STARx Transition Readiness Questionnaire (Parent Version); TRAQ, Transition Readiness Assessment Questionnaire.