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

Sponsor

University Children's Hospital, Zurich (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05413278

Collaborator

(none)

Enrollment

Locations

Arm

Anticipated Duration (Months)

2.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Transition Inborn Errors of Metabolism	Behavioral: Behavioral	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

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

Arm

Intervention/Treatment

Other: Training

Patient education, empowerment, and information

Behavioral: Behavioral

Patient education, information and empowerment

Outcome Measures

Primary Outcome Measures

Disease and treatment knowledge [Change from baseline to 1 month]
Questionnaire, specifically constructed during project

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 25 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	University Childrens Hospital Vienna	Vienna	Austria	1090
2	University Hospital Vienna	Vienna	Austria	1090
3	University Childrens Hospital Basel	Basel	Switzerland
4	University Hospital Basel	Basel	Switzerland
5	University Childrens Hospital Bern	Bern	Switzerland
6	University Hospial Bern	Bern	Switzerland
7	University Childrens Hospital Zürich	Zürich	Switzerland	8032
8	University Hospital Zurich	Zürich	Switzerland

Sponsors and Collaborators

University Children's Hospital, Zurich

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Children's Hospital, Zurich

ClinicalTrials.gov Identifier:

NCT05413278

Other Study ID Numbers:

Fit_for_transfer

First Posted:

Jun 10, 2022

Last Update Posted:

Jun 10, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Metabolism, Inborn Errors

Study Results

No Results Posted as of Jun 10, 2022