Back to resultsTargeted Interventions for Successful Transition and Transfer of Adolescents With Inborn Errors of Metabolism to Adult Metabolic Services
Primary Purpose
Transition, Inborn Errors of Metabolism
Status
Not yet recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Behavioral
Sponsored by
About this trial
This is an interventional supportive care trial for Transition
Eligibility Criteria
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
Sites / Locations
- University Childrens Hospital Vienna
- University Hospital Vienna
- University Childrens Hospital Basel
- University Hospital Basel
- University Childrens Hospital Bern
- University Hospial Bern
- University Childrens Hospital Zürich
- University Hospital Zurich
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Training
Arm Description
Patient education, empowerment, and information
Outcomes
Primary Outcome Measures
Disease knowledge
interview, semistructured
Secondary Outcome Measures
Full Information
NCT ID
NCT05413278
First Posted
May 25, 2022
Last Updated
November 9, 2022
Sponsor
University Children's Hospital, Zurich
1. Study Identification
Unique Protocol Identification Number
NCT05413278
Brief Title
Targeted Interventions for Successful Transition and Transfer of Adolescents With Inborn Errors of Metabolism to Adult Metabolic Services
Official Title
Fit for Transfer: Targeted Interventions for Successful Transition and Transfer of Adolescents With Inborn Errors of Metabolism to Adult Metabolic Services
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2023 (Anticipated)
Primary Completion Date
September 1, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Children's Hospital, Zurich
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transition, Inborn Errors of Metabolism
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Training
Arm Type
Other
Arm Description
Patient education, empowerment, and information
Intervention Type
Behavioral
Intervention Name(s)
Behavioral
Intervention Description
Patient education, information and empowerment
Primary Outcome Measure Information:
Title
Disease knowledge
Description
interview, semistructured
Time Frame
change from baseline to 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University Childrens Hospital Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marion Herle
Facility Name
University Hospital Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miriam Hufgard-Leitner, MD
Facility Name
University Childrens Hospital Basel
City
Basel
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martina Huemer, MD
Facility Name
University Hospital Basel
City
Basel
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katharina Timper, MD
Facility Name
University Childrens Hospital Bern
City
Bern
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthias Gautschi, MD
Facility Name
University Hospial Bern
City
Bern
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michel Hochuli
Facility Name
University Childrens Hospital Zürich
City
Zürich
ZIP/Postal Code
8032
Country
Switzerland
Facility Name
University Hospital Zurich
City
Zürich
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Horka, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Targeted Interventions for Successful Transition and Transfer of Adolescents With Inborn Errors of Metabolism to Adult Metabolic Services
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