Type 1 Diabetes MellitusCOCCOSNCT07145671
The COCCOS Study: a Transition Program for Young Persons With Chronic Conditions
A study testing Transition program in people with Type 1 Diabetes Mellitus and Obesity, run by Universiteit Antwerpen at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes Mellitus, Obesity, Asthma
- What is being tested?
- Transition program
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteBelgium
- Study dates
- 13 Mar 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- For participants in the intervention group (IG):
- 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;
- planned to transfer to adult care within the next 12 months.
Show all 12Show fewer
- 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;
- who had at least one pediatric outpatient visit, prior to inclusion, in one of both hospitals within the past 12 months;
- are Dutch speaking;
- planned to transfer to adult care within the next 12 months.
Who cannot join
- Applicable for both CG and IG:
- patients with severe mental, cognitive or neurological problems will be excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The COCCOS Study: Implementing and Evaluating a Transition Program for Young Persons With Chronic Conditions
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.
Read the 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:
- Transition consultation (intro to transition and planning)
- Independent visit (AYAs attend without parents, guided by Ready Steady Go-checklist)
- Joint consultation (with pediatric and adult HCPs)
- 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 (MARS-5), 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.
- Conditions
- Type 1 Diabetes Mellitus, Obesity, Asthma
- Being tested
- Transition program
- Keywords
- adolescent, young adult, transitional care, transition program
- Medical subject headings
- Diabetes Mellitus, Type 1, Obesity, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transition programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Transition program |
| Standard care | No intervention | Participants in this arm will receive standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readiness to transition - TRAQ 6.0
Transition Readiness Assessment Questionnaire (TRAQ), version 6.0. As the primary aim of the TP is to prepare AYAs for transition to adult care, the primary outcome is transition readiness. This is assessed using the TRAQ (version 6.0) [25,26,28]. The TRAQ is a 20-item self-report instrument designed to evaluate the skills necessary for a successful transition. It covers four domains: (1) medication management, (2) appointment keeping, (3) tracking health issues, and (4) talking with providers. In addition, it includes two global transition readiness items. Items are scored on a 5-point Likert scale, with total scores ranging from 0 to 53, where higher scores indicate greater transition readiness [28]. Prior to use in this study, the TRAQ will be forward-backward translated into Dutch (Flemish) to ensure linguistic and cultural validity.
Measured: 12 months
Secondary outcomes (4)
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
Medication Adherence Report Scale (MARS-5)
Medication adherence is evaluated using the MARS-5, a brief 5-item measure assessing both intentional and unintentional non-adherent behaviours. Items address behaviours such as forgetting to take medication or deliberately altering doses. Each item is rated on a 5-point Likert scale, with higher scores indicating better adherence. The MARS-5 is widely used due to its simplicity and sensitivity to different types of non-adherence.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start13 Mar 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent, University Hospital, Ghent, University Hospital, Antwerp
- Responsible party
- Principal investigator, Eva Goossens, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145671
- Sponsor's protocol ID
- B3002024000166
- Other IDs
- G066622N
- Acronym
- COCCOS
- Status last verified
- Oct 2026
- First submitted
- 26 Jun 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Van Wilder L, Janssens N, Van Hoorenbeeck K, Vanden Wyngaert K, Goossens E, De Smedt D. The COCCOS study: A protocol for a multicentric quasi-experimental study of a healthcare transition program for young people with chronic conditions. PLoS One. 2026 Aug 17;21(8):e0353932. doi: 10.1371/journal.pone.0353932. eCollection 2026.
PubMed 42607051Janssens N, Van Wilder L, Vanden Wyngaert K, Van Hecke A, Van Hoorenbeeck K, Dupont E, Moerkens M, De Smedt D, Goossens E. COCCOS: a blueprint transition program for young people with chronic conditions using experience-based co-design. BMC Public Health. 2026 Mar 17;26(1):1343. doi: 10.1186/s12889-026-26966-5.
PubMed 41840380Janssens N, Van Wilder L, Vanden Wyngaert K, Van Hecke A, Van Hoorenbeeck K, Van Loock E, Dupont E, De Smedt D, Goossens E. Understanding young persons' experiences through healthcare transition. A qualitative study. Patient Educ Couns. 2025 Aug;137:108798. doi: 10.1016/j.pec.2025.108798. Epub 2025 Apr 26.
PubMed 40318540
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The COCCOS Study: Implementing and Evaluating a Transition Program for Young Persons With Chronic Conditions
- ClinicalTrials.gov ID
- NCT07145671
- Acronym / sponsor ID
- COCCOS / B3002024000166
- Conditions
- Type 1 Diabetes Mellitus, Obesity, Asthma
- Keywords
- adolescent, young adult, transitional care, transition program
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- University Ghent, University Hospital, Ghent, University Hospital, Antwerp
- Study start
- 13 Mar 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Aug 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.
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:
- Transition consultation (intro to transition and planning)
- Independent visit (AYAs attend without parents, guided by Ready Steady Go-checklist)
- Joint consultation (with pediatric and adult HCPs)
- 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 (MARS-5), 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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transition program | Experimental | Other: Transition programA 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 intervention | –Participants in this arm will receive standard of care. |
Who may qualify
- Ages
- 16 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- 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;
- planned to transfer to adult care within the next 12 months.
Key exclusion criteria (2 listed)
- patients with severe mental, cognitive or neurological problems will be excluded
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 |
|---|---|---|
| Transition programTransition 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. | Other | Transition program |
Primary outcome
Readiness to transition - TRAQ 6.0
Time frame: 12 months
Transition Readiness Assessment Questionnaire (TRAQ), version 6.0. As the primary aim of the TP is to prepare AYAs for transition to adult care, the primary outcome is transition readiness. This is assessed using the TRAQ (version 6.0) [25,26,28]. The TRAQ is a 20-item self-report instrument designed to evaluate the skills necessary for a successful transition. It covers four domains: (1) medication management, (2) appointment keeping, (3) tracking health issues, and (4) talking with providers. In addition, it includes two global transition readiness items. Items are scored on a 5-point Likert scale, with total scores ranging from 0 to 53, where higher scores indicate greater transition readiness [28]. Prior to use in this study, the TRAQ will be forward-backward translated into Dutch (Flemish) to ensure linguistic and cultural validity.
4 secondary outcomes
Generic Youth Patient Empowerment Scale (GYPES)
Time frame: 12 months
EQ-5D-5L
Time frame: 12 months
Hospital Anxiety and Depression Scale (HADS)
Time frame: 12 months
Medication Adherence Report Scale (MARS-5)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Background: PubMed 42607051Van Wilder L, Janssens N, Van Hoorenbeeck K, Vanden Wyngaert K, Goossens E, De Smedt D. The COCCOS study: A protocol for a multicentric quasi-experimental study of a healthcare transition program for young people with chronic conditions. PLoS One. 2026 Aug 17;21(8):e0353932. doi: 10.1371/journal.pone.0353932. eCollection 2026.
- Background: PubMed 41840380Janssens N, Van Wilder L, Vanden Wyngaert K, Van Hecke A, Van Hoorenbeeck K, Dupont E, Moerkens M, De Smedt D, Goossens E. COCCOS: a blueprint transition program for young people with chronic conditions using experience-based co-design. BMC Public Health. 2026 Mar 17;26(1):1343. doi: 10.1186/s12889-026-26966-5.
- Background: PubMed 40318540Janssens N, Van Wilder L, Vanden Wyngaert K, Van Hecke A, Van Hoorenbeeck K, Van Loock E, Dupont E, De Smedt D, Goossens E. Understanding young persons' experiences through healthcare transition. A qualitative study. Patient Educ Couns. 2025 Aug;137:108798. doi: 10.1016/j.pec.2025.108798. Epub 2025 Apr 26.
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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 Transition program in people with Type 1 Diabetes Mellitus and Obesity, run by Universiteit Antwerpen at 1 site in Belgium.
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 12 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 9 Oct 2026. 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
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?
Readiness to transition - TRAQ 6.0 (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07145671, which also lists 3 linked publications.
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 9 Oct 2026.