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

Inborn Errors of Metabolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05413278
• Other study ID #: Fit_for_transfer
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Inborn Errors of Metabolism
• Metabolism, Inborn Errors
• Transition

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