NCT07145671

Brief Summary

A study is undertaken to examine the feasibility of the newly developed transition program in adolescents with type 1 diabetes, asthma and obesity in a multicentric setting. Specific objectives for this study are: (1) examining the impact of the program in terms of patient-reported health outcomes, (2) examining patients' and healthcare providers' experiences related to the program implementation process, and (3) examining the impact of the program in terms of cost-effectiveness.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress67%
Mar 2025Dec 2026

Study Start

First participant enrolled

March 13, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 28, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

1.7 years

First QC Date

June 26, 2025

Last Update Submit

August 20, 2025

Conditions

Keywords

adolescentyoung adulttransitional caretransition program

Outcome Measures

Primary Outcomes (1)

  • Readiness to transition - TRAQ 6.0

    The TRAQ 6.0 (Transition Readiness Assessment Questionnaire version 6.0) is a tool designed to assess the readiness of youth with special healthcare needs to transition from pediatric to adult healthcare systems. It evaluates self-management and self-advocacy skills across key domains. The TRAQ 6.0 Dutch Version will be used. The TRAQ 6.0 has 20 items, with a theoretical range from 20 to 100. High TRAQ scores indicate a high level of transition readiness reflecting the individual demonstrates strong self-management and self-advocacy skills, such as managing medications, appointments, insurance, and understanding their own medical condition. Higher scores suggest the youth may be ready or nearly ready for transition to adult care. Low TRAQ scores indicate low transition readiness, indicating that the youth may lack knowledge or confidence in managing aspects of their healthcare, this reflects a need for additional support, education, or targeted transition planning.

    12 months

Secondary Outcomes (4)

  • Generic Youth Patient Empowerment Scale (GYPES)

    12 months

  • Morisky Medication Adherence Scale (MMAS)

    12 months

  • EQ-5D-5L

    12 months

  • Hospital Anxiety and Depression Scale (HADS)

    12 months

Study Arms (2)

Transition program

EXPERIMENTAL

A transition program (TP) was developed, as part of the first work package of the COCCOS project, in close collaboration with stakeholders (i.e., AYA patients, parents and HCPs) based on participatory action research methods (i.e., Experience-Based Co Design, including photovoice). Based on this study, the developed TP entailed four key moments: (i) a transition consultation, (ii) a consultation without parents, (iii) a joint consultation, and (iv) a feedback moment. Over a course of approximately 9-15 months (this can differ considering different pathologies have different care trajectories (e.g., frequency of consultations)), AYAs will receive an intensive person-centered transition program consisting of the four key moments.

Other: Transition program

Standard care

NO INTERVENTION

Participants in this arm will receive standard of care.

Interventions

Transition Consultation: Pediatric HCP introduces the transition process to AYA and family. A contact person is assigned (ideally the AYA's trusted HCP), along with someone from the AYA's personal network. Key points are recorded in the Individualized Transition Plan (ITP). Independent Visit: AYA has a solo consultation (parents briefly step out). They complete the Ready Steady Go checklist. The ITP is updated, and concerns are discussed. Joint Consultation: Pediatric and adult HCPs meet with the AYA. A new adult contact is assigned, and the AYA picks a pediatric contact for feedback. Checklist is completed again. Feedback Moment: After transfer, the pediatric contact checks in. The checklist guides discussion; feedback is shared across teams, and follow-up arranged if needed.

Transition program

Eligibility Criteria

Age16 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • For participants in the intervention group (IG):
  • years old;
  • diagnosed with type 1 diabetes, asthma and/or obesity;
  • are Dutch speaking;
  • planned to transfer to adult care within the next 12 months.
  • For participants in the control group (CG):
  • age 17,5 and 18 years old, as the control period has a shorter duration (4 months vs. 12 months)
  • diagnosed with type 1 diabetes, asthma and/or obesity;
  • are Dutch speaking;
  • planned to transfer to adult care within the next 12 months.

You may not qualify if:

  • Applicable for both CG and IG:
  • \- patients with severe mental, cognitive or neurological problems will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1ObesityAsthma

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivity

Central Study Contacts

Eva Goossens, Professor

CONTACT

Natwarin Janssens

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

June 26, 2025

First Posted

August 28, 2025

Study Start

March 13, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

August 28, 2025

Record last verified: 2025-08

Locations