TransitionNCT05413278
Targeted Interventions for Successful Transition and Transfer of Adolescents With Inborn Errors of Metabolism to Adult Services
A study testing Behavioral in people with Transition and Inborn Errors of Metabolism, run by University Children's Hospital, Zurich at 8 sites in 2 countries.
Trial summary
Main aims of this project are To assess the baseline status-quo of transition and "fitness for transfer" in terms of information about the adult centre and team, organisational and practical skills (blood sampling and sending, how to make an appointment etc.), disease- and treatment-related knowledge, health-related… Read more about this study
- Who is it for?
- Ages 14 to 25 years
- Conditions the study is for
- Transition, Inborn Errors of Metabolism
- What is being tested?
- Behavioral
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 1 Jan 2024to 31 Dec 2025
- Phase
- Interventional
- 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 14 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- with an inborn error of metabolism in the care of a specialized metabolic care unit
- requiring specialized adult metabolic care
- at least 14 years old
- with a disease for which at least one biochemical and / or physical parameter disease marker is well established .
Who cannot join
- Patients -
- with insufficient knowledge of the German
- with cognitive impairment to a degree that consent, and participation would be impossible
- in an end-of-life situation
- with a disease for which no biochemical and / or physical parameter disease marker is well established
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Switzerland6 sites, 6 recruiting
- Recruiting
University Childrens Hospital Basel
Basel
Martina Huemer, MD, +41 61 704 12 12, martina.huemer@ukbb.ch
- Recruiting
University Hospital Basel
Basel
Katharina Timper, MD, +41 61 207 07 73, katharina.timper@usb.ch
- Recruiting
University Childrens Hospital Bern
Bern
Matthias Gautschi, MD, +41 31 63 2 01 47, matthias.gautschi@insel.ch
- Recruiting
University Hospial Bern
Bern
Michel Hochuli, +41 31 63 2 01 47, michel.hochuli@insel.ch
- Recruiting
University Childrens Hospital Zürich
Zurich, 8032
Martina Huemer, Prof, +41442667593, martina.huemer@kispi.uzh.ch
- Recruiting
University Hospital Zurich
Zurich
Laura Horka, MD, +41 44 255 36 20, laura.horka@usz.ch
Austria2 sites, 2 recruiting
- Recruiting
University Childrens Hospital Vienna
Vienna, 1090
Marion Herle, +43140400, marion.herle@meduniwien.ac.at
- Recruiting
University Hospital Vienna
Vienna, 1090
Miriam Hufgard-Leitner, MD, +43140400, miriam.hufgard@meduniwien.ac.at
About this study
Official title: Fit for Transfer: Targeted Interventions for Successful Transition and Transfer of Adolescents With Inborn Errors of Metabolism to Adult Metabolic Services
Main aims of this project are
- To assess the baseline status-quo of transition and "fitness for transfer" in terms of information about the adult centre and team, organisational and practical skills (blood sampling and sending, how to make an appointment etc.), disease- and treatment-related knowledge, health-related quality of life (HrQoL), and self-efficacy in adolescnets with inborn errors of metabolism. Biochemical or physical parameters as appropriate for the respective diseases from 12 months before are documented.
- To provide targeted, structured intervention modules (using available and, if necessary, adapted materials).
- To measure the effects of these interventions on information about adult services short-term (within a month) and to re-assess all other baseline status-quo parameters long-term (6 and 12 months later). Psychological assessments will be complemented by biochemical or physical parameters as appropriate for the respective diseases and indicative for transition success.
- Conditions
- Transition, Inborn Errors of Metabolism
- Being tested
- Behavioral
- Medical subject headings
- Metabolism, Inborn Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BehavioralBehavioural
Patient education, information and empowerment
| Study group | Role | What they receive |
|---|---|---|
| Training | Other | Patient education, empowerment, and information Receives: Behavioral: Behavioral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease knowledge
interview, semistructured
Measured: change from baseline to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start1 Jan 2024
- Primary completion1 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TransitionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05413278
- Sponsor's protocol ID
- Fit_for_transfer
- Status last verified
- Aug 2024
- First submitted
- 25 May 2022
- Last updated
- 6 Aug 2024
- 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 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fit for Transfer: Targeted Interventions for Successful Transition and Transfer of Adolescents With Inborn Errors of Metabolism to Adult Metabolic Services
- ClinicalTrials.gov ID
- NCT05413278
- Acronym / sponsor ID
- Fit_for_transfer
- Conditions
- Transition, Inborn Errors of Metabolism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Jun 2022 (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.
Main aims of this project are
- To assess the baseline status-quo of transition and "fitness for transfer" in terms of information about the adult centre and team, organisational and practical skills (blood sampling and sending, how to make an appointment etc.), disease- and treatment-related knowledge, health-related quality of life (HrQoL), and self-efficacy in adolescnets with inborn errors of metabolism. Biochemical or physical parameters as appropriate for the respective diseases from 12 months before are documented.
- To provide targeted, structured intervention modules (using available and, if necessary, adapted materials).
- To measure the effects of these interventions on information about adult services short-term (within a month) and to re-assess all other baseline status-quo parameters long-term (6 and 12 months later). Psychological assessments will be complemented by biochemical or physical parameters as appropriate for the respective diseases and indicative for transition success.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Training | Other | Behavioral: BehavioralPatient education, empowerment, and information |
Who may qualify
- Ages
- 14 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- with an inborn error of metabolism in the care of a specialized metabolic care unit
- requiring specialized adult metabolic care
- at least 14 years old
- with a disease for which at least one biochemical and / or physical parameter disease marker is well established .
Key exclusion criteria (5 listed)
- Patients -
- with insufficient knowledge of the German
- with cognitive impairment to a degree that consent, and participation would be impossible
- in an end-of-life situation
- with a disease for which no biochemical and / or physical parameter disease marker is well established
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 |
|---|---|---|
| BehavioralPatient education, information and empowerment | Behavioural | Training |
Primary outcome
Disease knowledge
Time frame: change from baseline to 1 month
interview, semistructured
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- 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.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral in people with Transition and Inborn Errors of Metabolism, run by University Children's Hospital, Zurich at 8 sites in 2 countries.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Switzerland, Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease knowledge (time frame: change from baseline to 1 month). 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 6 Aug 2024.