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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05413278
Other study ID # Fit_for_transfer
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2024
Est. completion date December 31, 2025

Study information

Verified date December 2023
Source University Children's Hospital, Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date December 31, 2025
Est. primary completion date September 1, 2025
Accepts healthy volunteers No
Gender All
Age group 14 Years to 25 Years
Eligibility 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

Study Design


Intervention

Behavioral:
Behavioral
Patient education, information and empowerment

Locations

Country Name City State
Austria University Childrens Hospital Vienna Vienna
Austria University Hospital Vienna Vienna
Switzerland University Childrens Hospital Basel Basel
Switzerland University Hospital Basel Basel
Switzerland University Childrens Hospital Bern Bern
Switzerland University Hospial Bern Bern
Switzerland University Childrens Hospital Zürich Zürich
Switzerland University Hospital Zurich Zürich

Sponsors (1)

Lead Sponsor Collaborator
University Children's Hospital, Zurich

Countries where clinical trial is conducted

Austria,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Disease knowledge interview, semistructured change from baseline to 1 month
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