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

NCT ID: NCT05413278

Last Updated: 2024-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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Transition Inborn Errors of Metabolism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Training

Patient education, empowerment, and information

Group Type OTHER

Behavioral

Intervention Type BEHAVIORAL

Patient education, information and empowerment

Interventions

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Behavioral

Patient education, information and empowerment

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

14 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Children's Hospital, Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Childrens Hospital Vienna

Vienna, , Austria

Site Status RECRUITING

University Hospital Vienna

Vienna, , Austria

Site Status RECRUITING

University Childrens Hospital Basel

Basel, , Switzerland

Site Status RECRUITING

University Hospital Basel

Basel, , Switzerland

Site Status RECRUITING

University Childrens Hospital Bern

Bern, , Switzerland

Site Status RECRUITING

University Hospial Bern

Bern, , Switzerland

Site Status RECRUITING

University Childrens Hospital Zürich

Zurich, , Switzerland

Site Status RECRUITING

University Hospital Zurich

Zurich, , Switzerland

Site Status RECRUITING

Countries

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Austria Switzerland

Facility Contacts

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Marion Herle

Role: primary

+43140400

Miriam Hufgard-Leitner, MD

Role: primary

+43140400

Martina Huemer, MD

Role: primary

+41 61 704 12 12

Katharina Timper, MD

Role: primary

+41 61 207 07 73

Matthias Gautschi, MD

Role: primary

+41 31 63 2 01 47

Michel Hochuli

Role: primary

+41 31 63 2 01 47

Martina Huemer, Prof

Role: primary

+41442667593

Laura Horka, MD

Role: primary

+41 44 255 36 20

Other Identifiers

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Fit_for_transfer

Identifier Type: -

Identifier Source: org_study_id

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