Inflammatory Bowel Disease (IBD)NCT06946810
Impact of Transition Programs on Readiness and Quality of Life in IBD
A study testing Combined visits-based transition and Letter-based transition in people with Inflammatory Bowel Disease (IBD), run by University of Padova at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 16 to 19 years
- Conditions the study is for
- Inflammatory Bowel Disease (IBD)
- What is being tested?
- Combined visits-based transition and Letter-based transition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2019to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Written informed consent
- IBD diagnosis according to current guidelines
- Age between 16 and 19 years
- Disease in clinical remission or with mild activity
Who cannot join
- Subjects unable to provide a free and valid consent to study participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Two TRAnsition Programs on Transition Readiness and Quality of Life in Inflammatory Bowel Disease: a Randomized Controlled Trial
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.
- Conditions
- Inflammatory Bowel Disease (IBD)
- Being tested
- Combined visits-based transition, Letter-based transition
- Keywords
- Transition, Pediatric, Inflammatory Bowel Disease
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined visits-based transitionBehavioural
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.
Letter-based transitionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Letter-based transition |
| 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. Receives: Behavioral: Combined visits-based transition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and at end of transition period (approximately 12 months)
Secondary outcomes (9)
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.
Measured: Baseline (Day 0), intermediate visit (Month 6), and end of transition period (Month 12)
Healthcare utilization
Tracking of hospitalizations, surgeries, and unplanned healthcare visits related to IBD during the transition period.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start1 Jan 2019
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Disease (IBD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZINGONE FABIANA, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06946810
- Sponsor's protocol ID
- 5385/AO/22
- Status last verified
- Apr 2025
- First submitted
- 12 Apr 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Two TRAnsition Programs on Transition Readiness and Quality of Life in Inflammatory Bowel Disease: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06946810
- Acronym / sponsor ID
- 5385/AO/22
- Conditions
- Inflammatory Bowel Disease (IBD)
- Keywords
- Transition, Pediatric, Inflammatory Bowel Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 27 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Letter-based transition group | Active comparator | Behavioral: Letter-based transitionIn 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. |
| Combined visits-based transition | Experimental | Behavioral: Combined visits-based transitionIn 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. |
Who may qualify
- Ages
- 16 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Written informed consent
- IBD diagnosis according to current guidelines
- Age between 16 and 19 years
- Disease in clinical remission or with mild activity
Key exclusion criteria (1 listed)
- Subjects unable to provide a free and valid consent to study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined visits-based transitionIn 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. | Behavioural | Combined visits-based transition |
| Letter-based transitionIn 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. | Behavioural | Letter-based transition group |
Primary outcome
Transition readiness as measured by the Transition Readiness Assessment Questionnaire (TRAQ)
Time frame: Baseline and at end of transition period (approximately 12 months)
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.
9 secondary outcomes
Quality of life as measured by the Pediatric Quality of Life Inventory™ (PedsQL™)
Time frame: Baseline (Day 0), intermediate visit (Month 6), and end of transition period (Month 12)
Healthcare utilization
Time frame: Throughout study period (Month 0 to Month 12)
Quality of life as measured by the Pediatric Quality of Life Inventory™ (PedsQL™)
Time frame: Baseline (T0), intermediate visit (T2), and end of transition period (T3, approximately 12 months)
Disease activity in Crohn's Disease patients
Time frame: Baseline (Day 0), intermediate visit (Month 6), and end of transition period (Month 12)
Disease activity in Ulcerative Colitis patients
Time frame: Baseline (Day 0), intermediate visit (Month 6), and end of transition period (Month 12)
C-reactive protein (CRP) levels
Time frame: Baseline (Day 0), intermediate visit (Month 6), and end of transition period (Month 12)
Fecal calprotectin levels
Time frame: Baseline (Day 0), intermediate visit (Month 6), and end of transition period (Month 12)
Incidence of treatment modifications
Time frame: Throughout study period (Month 0 to Month 12)
Transition readiness perception
Time frame: Baseline (Day 0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined visits-based transition and Letter-based transition in people with Inflammatory Bowel Disease (IBD), run by University of Padova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transition readiness as measured by the Transition Readiness Assessment Questionnaire (TRAQ) (time frame: Baseline and at end of transition period (approximately 12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.