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

Not Applicable

Recruiting

• Conditions: Type 1 Diabetes Mellitus; Obesity; Asthma

• Registration Number: NCT07145671
• Lead Sponsor: Universiteit Antwerpen

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.

Detailed Description

Chronic conditions are increasingly common in youth, with 10-25% affected and over 85% reaching adulthood. This rise stems from higher incidence of conditions like diabetes and improved survival of congenital diseases. These young patients face a lifelong risk of complications, requiring continuous, age-appropriate care. A well-managed transfer from pediatric to adult care is essential, yet up to half of adolescents lack adequate preparation. Poor transitions can lead to care disruption, worse health outcomes, and higher costs. Structured transition programs (TPs) can improve self-management, adherence, and health outcomes, while reducing costs. However, implementation and long-term integration of TPs remain limited, especially for common chronic conditions. Following the development of a TP through Experience-Based Co-Design in the COCCOS project, the next phase involves a feasibility study to assess its preliminary impact.

A multicenter, quasi-experimental pre-test post-test study will assess a co-designed transition program at two Belgian hospitals (UZA and UZ Ghent), comparing it to usual care. AYAs aged 17-18 with type 1 diabetes, asthma, or obesity will be recruited (n=150). The intervention group will receive the TP over 9-15 months; the control group (CG) will receive usual care. Assessments occur at baseline, transfer, and 4 months post-transfer.

The TP includes four stages:

1. Transition consultation (intro to transition and planning)

2. Independent visit (AYAs attend without parents, guided by Ready Steady Go-checklist)

3. Joint consultation (with pediatric and adult HCPs)

4. Feedback moment (post-transfer evaluation) An individualized transition plan (ITP) will be created and used throughout the TP. This ITP will be available via hospital portals, where AYAs can review and update their plan as needed.

The primary outcome of the study is transition readiness, measured using the Transition Readiness Assessment Questionnaire (TRAQ). Secondary outcomes include patient empowerment (GYPES), medication adherence (MMAS), quality of life (EQ-5D-5L), and anxiety and depression (HADS). Clinical indicators such as emergency visits, missed consultations, and disease-specific biomarkers will also be collected. Data will be analyzed using descriptive statistics, paired and independent t-tests, and multivariable regression analyses. To account for baseline differences between groups, inverse probability treatment weighting (IPTW) will be applied. Significance will be set at p \< 0.05. A process evaluation will be conducted alongside the effect evaluation to understand how the TP was implemented and received by AYAs, families, and healthcare providers. Data will be gathered using observations, satisfaction questionnaires, and semi-structured interviews. Evaluation will focus on fidelity, dose delivered and received, reach, contextual influences, and any adaptations made during the intervention. Qualitative data will be analyzed thematically using NVivo software. The cost-effectiveness of the TP will be assessed using a health economic model, developed in accordance with ISPOR guidelines. Cost data will include implementation expenses and healthcare utilization, while effectiveness data will focus on quality-adjusted life years (QALYs) derived from the EQ-5D-5L. The model will calculate an incremental cost-effectiveness ratio (ICER) comparing the TP with usual care. Sensitivity analyses and bootstrapping will be performed to address uncertainty, and cost-effectiveness acceptability curves will be generated to assess the probability of the TP being cost-effective at various willingness-to-pay thresholds.

Study Timeline

• Study Start: 2025-03-13
• Study First Submitted: 2025-06-26
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-20
• Last Update Submitted: 2025-08-20
• Study First Posted: 2025-08-28
• Last Update Posted: 2025-08-28
• Primary Completion: 2026-12
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Readiness to transition - TRAQ 6.0	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Generic Youth Patient Empowerment Scale (GYPES)	12 months	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.
Morisky Medication Adherence Scale (MMAS)	12 months	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.
EQ-5D-5L	12 months	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.
Hospital Anxiety and Depression Scale (HADS)	12 months	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.

Trial Locations

Locations (1)

Ghent University Hospital; 🇧🇪 Ghent, Belgium