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

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.

Study Overview

• Status: Recruiting
• Conditions: Inborn Errors of Metabolism; Transition
• Intervention / Treatment: Behavioral: Behavioral

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • University Hospital Vienna
    • Contact: Miriam Hufgard-Leitner, MD; Phone Number: +43140400; Email: miriam.hufgard@meduniwien.ac.at
  • Vienna, Austria, 1090
    • Recruiting
    • University Childrens Hospital Vienna
    • Contact: Marion Herle; Phone Number: +43140400; Email: marion.herle@meduniwien.ac.at
• Switzerland
  • Basel, Switzerland
    • Recruiting
    • University Hospital Basel
    • Contact: Katharina Timper, MD; Phone Number: +41 61 207 07 73; Email: katharina.timper@usb.ch
  • Basel, Switzerland
    • Recruiting
    • University Childrens Hospital Basel
    • Contact: Martina Huemer, MD; Phone Number: +41 61 704 12 12; Email: martina.huemer@ukbb.ch
  • Bern, Switzerland
    • Recruiting
    • University Childrens Hospital Bern
    • Contact: Matthias Gautschi, MD; Phone Number: +41 31 63 2 01 47; Email: matthias.gautschi@insel.ch
  • Bern, Switzerland
    • Recruiting
    • University Hospial Bern
    • Contact: Michel Hochuli; Phone Number: +41 31 63 2 01 47; Email: michel.hochuli@insel.ch
  • Zürich, Switzerland
    • Recruiting
    • University Hospital Zurich
    • Contact: Laura Horka, MD; Phone Number: +41 44 255 36 20; Email: laura.horka@usz.ch
  • Zürich, Switzerland, 8032
    • Recruiting
    • University Childrens Hospital Zürich
    • Contact: Martina Huemer, Prof; Phone Number: +41442667593; Email: martina.huemer@kispi.uzh.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Training; Patient education, empowerment, and information	Behavioral: Behavioral; Patient education, information and empowerment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease knowledge	interview, semistructured	change from baseline to 1 month

Collaborators and Investigators

• Sponsor: University Children's Hospital, Zurich

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 25, 2022
• First Submitted That Met QC Criteria: June 7, 2022
• First Posted (Actual): June 10, 2022

Study Record Updates

• Last Update Posted (Actual): August 6, 2024
• Last Update Submitted That Met QC Criteria: August 5, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Metabolism, Inborn Errors
• Other Study ID Numbers: Fit_for_transfer

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No