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This study is a randomized controlled trial comparing two transition models for adolescents with inflammatory bowel disease (IBD) moving from pediatric to adult care. Patients aged 16-19 years with IBD will be randomized to either a letter-based transition approach (involving a referral supported by a pediatrician's clinical report) or a combined visits-based approach (including joint consultations with both pediatric and adult gastroenterologists).
The primary outcome will be transition readiness assessed using the Transition Readiness Assessment Questionnaire (TRAQ). Secondary outcomes include quality of life (measured by the Pediatric Quality of Life Inventory™), disease activity, and healthcare utilization. Participants will be evaluated at baseline, six months, and one year. The study aims to establish an evidence-based transition model by determining which approach better facilitates a successful transition from pediatric to adult gastroenterology care for young patients with IBD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Letter-based transition group | Active Comparator | In this arm, patients are transitioned from pediatric to adult gastroenterology care through a referral system where the pediatrician prepares a comprehensive clinical report that accompanies the patient to their first adult gastroenterology appointment. The transition occurs without joint visits between pediatric and adult specialists. |
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| Combined visits-based transition | Experimental | In this arm, patients experience a gradual transition involving joint consultations where both pediatric and adult gastroenterologists are present. This includes at least one combined visit at the pediatric clinic and one at the adult clinic, allowing for collaborative care and direct communication between all parties during the transition process. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined visits-based transition | Behavioral | In this arm, patients experience a gradual transition involving joint consultations where both pediatric and adult gastroenterologists are present. This includes at least one combined visit at the pediatric clinic and one at the adult clinic, allowing for collaborative care and direct communication between all parties during the transition process. |
| Measure | Description | Time Frame |
|---|---|---|
| Transition readiness as measured by the Transition Readiness Assessment Questionnaire (TRAQ) | The TRAQ is a validated 20-item questionnaire that assesses youths' ability to manage their health independently. It evaluates five domains: Appointment Keeping, Tracking Health Issues, Managing Medications, Talking with Providers, and Managing Daily Activities. Scores range from 1-5 for each item, with higher scores indicating greater transition readiness. | Baseline and at end of transition period (approximately 12 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life as measured by the Pediatric Quality of Life Inventory™ (PedsQL™) | The PedsQL™ measures health-related quality of life in healthy children and adolescents and those with chronic conditions. It includes Physical, Emotional, Social, and School Functioning domains with scores ranging from 0-100, where higher scores indicate better quality of life. | Baseline (Day 0), intermediate visit (Month 6), and end of transition period (Month 12) |
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Inclusion Criteria:
Exclusion Criteria:
- Subjects unable to provide a free and valid consent to study participation
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedale - Università Padova | Padova | PD | 35122 | Italy |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| Letter-based transition | Behavioral | In this arm, patients are transitioned from pediatric to adult gastroenterology care through a referral system where the pediatrician prepares a comprehensive clinical report that accompanies the patient to their first adult gastroenterology appointment. The transition occurs without joint visits between pediatric and adult specialists. |
|
| Healthcare utilization | Tracking of hospitalizations, surgeries, and unplanned healthcare visits related to IBD during the transition period. | Throughout study period (Month 0 to Month 12) |
| Quality of life as measured by the Pediatric Quality of Life Inventory™ (PedsQL™) | The PedsQL™ measures health-related quality of life in healthy children and adolescents and those with chronic conditions. It includes Physical, Emotional, Social, and School Functioning domains with scores ranging from 0-100, where higher scores indicate better quality of life. | Baseline (T0), intermediate visit (T2), and end of transition period (T3, approximately 12 months) |
| Disease activity in Crohn's Disease patients | Disease activity will be measured using the Pediatric Crohn's Disease Activity Index (PCDAI) for pediatric patients or Harvey-Bradshaw Index (HBI) for adult patients. PCDAI scores range from 0-100 with remission defined as <10; HBI scores range from 0-25+ with remission defined as <5. For both scales, higher scores indicate more severe disease activity. | Baseline (Day 0), intermediate visit (Month 6), and end of transition period (Month 12) |
| Disease activity in Ulcerative Colitis patients | Disease activity will be measured using the Pediatric Ulcerative Colitis Activity Index (PUCAI) for pediatric patients or partial Mayo score for adult patients. PUCAI scores range from 0-85 with remission defined as <10; partial Mayo scores range from 0-9 with remission defined as 0-1. For both scales, higher scores indicate more severe disease activity. | Baseline (Day 0), intermediate visit (Month 6), and end of transition period (Month 12) |
| C-reactive protein (CRP) levels | Blood concentration of CRP measured in mg/dL as an objective marker of inflammation. Normal value is <0.5 mg/dL, with higher values indicating active inflammation. | Baseline (Day 0), intermediate visit (Month 6), and end of transition period (Month 12) |
| Fecal calprotectin levels | Concentration of fecal calprotectin measured in mg/Kg as an objective marker of intestinal inflammation. Normal value is <250 mg/Kg, with higher values indicating active intestinal inflammation. | Baseline (Day 0), intermediate visit (Month 6), and end of transition period (Month 12) |
| Incidence of treatment modifications | The number and type of changes in medical management (medication additions, discontinuations, or dosage adjustments) initiated during the transition period. | Throughout study period (Month 0 to Month 12) |
| Transition readiness perception | Visual Analog Scale (VAS) scores from patients, parents, and pediatricians assessing perception of readiness for transition. Scores range from 0-10, with higher scores indicating greater perceived readiness. | Baseline (Day 0) |