The COCCOS Study: a Transition Program for Young Persons With Chronic Conditions

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-21
SponsorUniversiteit Antwerpen

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

17 years old;

diagnosed with type 1 diabetes, asthma and/or obesity;

who had at least one pediatric outpatient visit, prior to inclusion, in one of both hospitals within the past 12 months;

are Dutch speaking;

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transition program

    Other intervention

    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.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Transition programExperimental treatment 1 intervention
Group B: Standard careNo intervention 0 interventions

Trial outcomes

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.

Time frame
12 months

Secondary outcomes

1

Generic Youth Patient Empowerment Scale (GYPES)

The Generic Youth Patient Empowerment Scale (GYPES) is a 15-item questionnaire designed to assess the level of empowerment in young patients with chronic conditions. Using a 5-point Likert scale, it yields a total score ranging from 15 to 75. Higher scores reflect greater empowerment, indicating that the young person feels more knowledgeable, confident, and involved in managing their healthcare, while lower scores suggest a need for additional support to strengthen self-management and engagement.

Time frame
12 months
2

Morisky Medication Adherence Scale (MMAS)

The Morisky Medication Adherence Scale (MMAS) is a self-reported questionnaire designed to assess a patient's adherence to prescribed medication. It includes 8 items, with scores ranging from 0 to 8. Higher scores indicate better medication adherence, while lower scores suggest potential issues with taking medications as prescribed and may signal the need for interventions to improve adherence.

Time frame
12 months
3

EQ-5D-5L

The EQ-5D-5L is a standardized questionnaire used to assess health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on five levels of severity, and responses are combined into a single health profile that can be converted into an index score, typically ranging from less than 0 (representing health states worse than death) to 1 (representing full health). Higher scores reflect better perceived quality of life, while lower scores indicate greater health-related challenges.

Time frame
12 months
4

Hospital Anxiety and Depression Scale (HADS)

The Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire used to assess levels of anxiety and depression in individuals with physical health problems. It consists of two subscales-anxiety and depression-each with 7 items, scored from 0 to 21. Higher scores indicate greater levels of anxiety or depression, with scores of 0-7 considered normal, 8-10 borderline, and 11-21 indicating clinically significant symptoms.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universiteit Antwerpen

Lead sponsor

University Ghent

Collaborator

University Hospital, Ghent

Collaborator

University Hospital, Antwerp

Collaborator