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Status unknownNCT05413278Updated Aug 6, 2024

Targeted Interventions for Successful Transition and Transfer of Adolescents With Inborn Errors of Metabolism to Adult Services

An interventional study of Behavioral in Transition and Inborn Errors of Metabolism, sponsored by University Children's Hospital, Zurich. Status unknown at 8 sites in 2 countries. Open to participants aged 14 Years to 25 Years. Per ClinicalTrials.gov, last updated 2024-08-06.

Sponsored by University Children's Hospital, Zurich · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Aug 2024), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
14 Years to 25 Years
Sex
All
01

Study 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 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.
02

Conditions studied

  • Transition
  • Inborn Errors of Metabolism
03

In context

Metabolism, Inborn Errors

110 studies on the registry are indexed under Metabolism, Inborn Errors; 23 are open to participants now.

This study's planned enrollment of 20 is below the median of 30 across 65 interventional studies indexed under Metabolism, Inborn Errors.

Browse Metabolism, Inborn Errors studies →

Lead sponsor

University Children's Hospital, Zurich is the lead sponsor of 95 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:Patients

  • 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 .

Exclusion Criteria:

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Other
    Training

    Patient education, empowerment, and information

    Behavioral: Behavioral

Interventions

  • BehavioralBehavioral

    Patient education, information and empowerment

06

What researchers measure

Primary outcomes

  1. Disease knowledge

    interview, semistructured

    Time frame: change from baseline to 1 month

07

Study locations

8 of 8 sites recruiting
  • University Childrens Hospital Vienna
    Vienna, 1090, Austria
    Recruiting
  • University Hospital Vienna
    Vienna, 1090, Austria
    Recruiting
  • University Childrens Hospital Basel
    Basel, Switzerland
    Recruiting
  • University Hospital Basel
    Basel, Switzerland
    Recruiting
  • University Childrens Hospital Bern
    Bern, Switzerland
    Recruiting
  • University Hospial Bern
    Bern, Switzerland
    Recruiting
  • University Childrens Hospital Zürich
    Zurich, 8032, Switzerland
    Recruiting
  • University Hospital Zurich
    Zurich, Switzerland
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2024 (actual). Primary completion is estimated for Sep 2025, 20 months after the start.

Of 15 interventional studies with no phase under Metabolism, Inborn Errors, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's planned 20 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
May 25, 2022
First posted
Jun 10, 2022
StartActual
Jan 1, 2024
Primary completionEst.
Sep 1, 2025
CompletionEst.
Dec 31, 2025
Last update
Aug 6, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05413278
Lead sponsor
University Children's Hospital, Zurich
Responsible party
Sponsor
First posted
Jun 10, 2022
Start date
Jan 1, 2024
Primary completion
Sep 1, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Aug 6, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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