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

Not Applicable

Recruiting

• Conditions: Transition; Inborn Errors of Metabolism
• Interventions: Behavioral: Behavioral

• Registration Number: NCT05413278
• Lead Sponsor: University Children's Hospital, Zurich

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-25
• Study First Submitted QC: 2022-06-07
• Study First Posted: 2022-06-10
• Study Start: 2024-01-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-06
• Primary Completion: 2025-09-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Training	Behavioral	Patient education, empowerment, and information

Primary Outcome Measures

Name	Time	Method
Disease knowledge	change from baseline to 1 month	interview, semistructured

Trial Locations

Locations (8)

University Childrens Hospital Basel; 🇨🇭 Basel, Switzerland

University Hospital Vienna; 🇦🇹 Vienna, Austria

University Hospial Bern; 🇨🇭 Bern, Switzerland

University Childrens Hospital Vienna; 🇦🇹 Vienna, Austria

University Hospital Basel; 🇨🇭 Basel, Switzerland

University Childrens Hospital Bern; 🇨🇭 Bern, Switzerland

University Childrens Hospital Zürich; 🇨🇭 Zürich, Switzerland

University Hospital Zurich; 🇨🇭 Zürich, Switzerland