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

NCT05413278 | Recruiting

• 1 other identifier: Fit_for_transfer
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 8

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.

Conditions

Transition; Inborn Errors of Metabolism

Outcome Measures

Primary Outcomes (1)

• Disease knowledge

  interview, semistructured

  change from baseline to 1 month

Study Arms (1)

Training

OTHER

Patient education, empowerment, and information

Behavioral: Behavioral

Interventions

Behavioral BEHAVIORAL

Patient education, information and empowerment

Training

Eligibility Criteria

• Age: 14 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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 .

You may not qualify if:

• 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

Sponsors & Collaborators

• University Children's Hospital, Zurich: lead

Study Sites (8)

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

MeSH Terms

Conditions

Metabolism, Inborn Errors

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: June 10, 2022
• Study Start: January 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 31, 2025
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (6); AU (2)