The COCCOS Study: a Transition Program for Young Persons With Chronic Conditions
COCCOS
The COCCOS Study: Implementing and Evaluating a Transition Program for Young Persons With Chronic Conditions
2 other identifiers
interventional
150
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2025
1 active site
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 Start
First participant enrolled
March 13, 2025
CompletedFirst Submitted
Initial submission to the registry
June 26, 2025
CompletedFirst Posted
Study publicly available on registry
August 28, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
August 28, 2025
August 1, 2025
1.7 years
June 26, 2025
August 20, 2025
Conditions
Keywords
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
EXPERIMENTALA 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.
Standard care
NO INTERVENTIONParticipants 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.
Eligibility Criteria
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
- Universiteit Antwerpenlead
- University Ghentcollaborator
- University Hospital, Ghentcollaborator
- University Hospital, Antwerpcollaborator
Study Sites (1)
Ghent University Hospital
Ghent, 9000, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
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