Chronic Conditions, MultipleNCT07852169
Psychometric Validation of the Flemish Version of the Transition Readiness Assessment Questionnaire (TRAQ 6.0) in Young People With Chronic Conditions
An observational study of Chronic Conditions, Multiple, run by Universiteit Antwerpen at 1 site in Belgium.
Trial summary
Healthcare transition, which involves preparing children and adolescents for the shift from pediatric to adult healthcare, received increased attention in recent years. Evidence and consensus suggest that effective healthcare transition has long-term benefits for patients, including better adherence to treatment… Read more about this study
- Who is it for?
- Ages 16 to 25 years
- Conditions the study is for
- Chronic Conditions, Multiple
- How many people
- 128 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2025to 31 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Eligible participants will be aged 16 to 25 years old, (ii) diagnosed with at least one chronic condition, (iii) attended at least one pediatric outpatient visit in a secondary or tertiary care hospital within the past 12 months prior to inclusion, and (iv) are able to read and speak Flemish Dutch. Patients with neurodevelopmental, cognitive or serious mental health issues will be excluded.
Who may be able to join
- aged 16 to 25 years old, diagnosed with at least one chronic condition, attended at least one pediatric outpatient visit in a secondary or tertiary care hospital within the past 12 months prior to inclusion, and are able to read and speak Flemish Dutch
Who cannot join
- neurodevelopmental, cognitive or serious mental health issues will be excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Psychometric Validation of the Flemish TRAQ 6.0 in Young People With Chronic Conditions
Healthcare transition, which involves preparing children and adolescents for the shift from pediatric to adult healthcare, received increased attention in recent years. Evidence and consensus suggest that effective healthcare transition has long-term benefits for patients, including better adherence to treatment, improved follow-up, and reduced morbidity. The American Academy of Pediatrics published guidelines in 2018 to facilitate good transitions, and similar guidelines were issued by NICE in 2016.
Various psychosocial questionnaires are available to assess the self-management skills of adolescents and young adults during this transition (i.e., transition readiness). The most well-known and widely used questionnaire is the Transition Readiness Assessment Questionnaire (TRAQ). Despite its widespread use and validation in other languages, there is currently no validated Flemish version.
Read more
This observational study aims to validate the Dutch version of the TRAQ for psychometric reliability.
The study will conduct a psychometric validation of the Flemish TRAQ 6.0 following the ISPOR guidelines. The validation process will include: Preparation and forward-backward translation; Harmonization between different language versions; and administering the final questionnaire to a larger sample to assess validity and reliability.
Demographic data (age, sex, ethnicity/nationality, and parental education level) and medical information (type of chronic condition, age of diagnosis, timing of transfer to adult care (if known), and unaccompanied hospital visits) will be collected.
The calculated sample size is 90 participants, with a significance level of 0.05, a power of 0.80, and an estimated effect size of 0.6. Considering a 40% risk of non-response, the final sample size will be at least 150 participants. Eligible participants are adolescents and young adults aged 16 to 25 years, diagnosed with at least one chronic condition, receiving medical follow-ups in secondary or tertiary care hospitals, and able to read and speak Flemish Dutch.
- Conditions
- Chronic Conditions, Multiple
- Medical subject headings
- Multiple Chronic Conditions
What is being measured
The primary outcome is the main question the study is designed to answer.
Transition Readiness Assessment Questionnaire
The revised TRAQ is divided into 4 domains containing a total of 20 items: managing medication (5 questions), appointment keeping (4 questions); tracking health issues (6 questions); and talking to providers (5 questions). Each question is rated on a 5-point Likert scale, ranging from score 1 ("No, I do not know how") to score 5 ("Yes, I always do this when I need to"), with higher scores indicating better readiness for transition. Additionally, two statements are added at the end of the questionnaire, assessing the importance and confidence in self-care management.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start1 Mar 2025
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Conditions, MultipleStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Principal investigator, Eva Goossens, Universiteit Antwerpen
- Investigators
- Eva Goossens, Professor, Principal investigator, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07852169
- Sponsor's protocol ID
- ONZ-2024-0327
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Psychometric Validation of the Flemish TRAQ 6.0 in Young People With Chronic Conditions
- ClinicalTrials.gov ID
- NCT07852169
- Acronym / sponsor ID
- ONZ-2024-0327
- Conditions
- Chronic Conditions, Multiple
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 1 Oct 2026 (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.
Healthcare transition, which involves preparing children and adolescents for the shift from pediatric to adult healthcare, received increased attention in recent years. Evidence and consensus suggest that effective healthcare transition has long-term benefits for patients, including better adherence to treatment, improved follow-up, and reduced morbidity. The American Academy of Pediatrics published guidelines in 2018 to facilitate good transitions, and similar guidelines were issued by NICE in 2016.
Various psychosocial questionnaires are available to assess the self-management skills of adolescents and young adults during this transition (i.e., transition readiness). The most well-known and widely used questionnaire is the Transition Readiness Assessment Questionnaire (TRAQ). Despite its widespread use and validation in other languages, there is currently no validated Flemish version.
This observational study aims to validate the Dutch version of the TRAQ for psychometric reliability.
The study will conduct a psychometric validation of the Flemish TRAQ 6.0 following the ISPOR guidelines. The validation process will include: Preparation and forward-backward translation; Harmonization between different language versions; and administering the final questionnaire to a larger sample to assess validity and reliability.
Demographic data (age, sex, ethnicity/nationality, and parental education level) and medical information (type of chronic condition, age of diagnosis, timing of transfer to adult care (if known), and unaccompanied hospital visits) will be collected.
The calculated sample size is 90 participants, with a significance level of 0.05, a power of 0.80, and an estimated effect size of 0.6. Considering a 40% risk of non-response, the final sample size will be at least 150 participants. Eligible participants are adolescents and young adults aged 16 to 25 years, diagnosed with at least one chronic condition, receiving medical follow-ups in secondary or tertiary care hospitals, and able to read and speak Flemish Dutch.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Eligible participants will be aged 16 to 25 years old, (ii) diagnosed with at least one chronic condition, (iii) attended at least one pediatric outpatient visit in a secondary or tertiary care hospital within the past 12 months prior to inclusion, and (iv) are able to read and speak Flemish Dutch. Patients with neurodevelopmental, cognitive or serious mental health issues will be excluded.
Key inclusion criteria (1 listed)
- aged 16 to 25 years old, diagnosed with at least one chronic condition, attended at least one pediatric outpatient visit in a secondary or tertiary care hospital within the past 12 months prior to inclusion, and are able to read and speak Flemish Dutch
Key exclusion criteria (1 listed)
- neurodevelopmental, cognitive or serious mental health issues 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.
Primary outcome
Transition Readiness Assessment Questionnaire
Time frame: Baseline
The revised TRAQ is divided into 4 domains containing a total of 20 items: managing medication (5 questions), appointment keeping (4 questions); tracking health issues (6 questions); and talking to providers (5 questions). Each question is rated on a 5-point Likert scale, ranging from score 1 ("No, I do not know how") to score 5 ("Yes, I always do this when I need to"), with higher scores indicating better readiness for transition. Additionally, two statements are added at the end of the questionnaire, assessing the importance and confidence in self-care management.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Eva Goossens, Professor principal investigator
Universiteit Antwerpen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Conditions, Multiple, 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 1 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Transition Readiness Assessment Questionnaire (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2026.