Parents' Occupation After Diabetes Onset

Type 1 Diabetes Clinical Trial

— AMBA  

Official title:

Long-term Occupational Consequences for Families of Children With Type 1 Diabetes: the Mothers Take the Burden

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04814849
• Other study ID #: 260320597
• Status: Completed
• Start date: December 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: March 2021
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A cross-sectional multicenter study using a questionnaire assessing occupational and financial situation before and after the onset of type 1 diabetes was distributed to all families with a child diagnosed with type 1 diabetes before the age of 14 years in nine German pediatric diabetes centers.

Description:

This cross-sectional multicenter study was conducted between January and June 2018 during a three months period per center. The selected nine pediatric diabetes centers covered all regions of Germany. The study participants were mothers, fathers, or other primary caregivers of children and adolescents diagnosed with type 1 diabetes before 14 years of age. During a regularly scheduled medical visit, in Germany usually 4 per year, families were informed about the study procedure, its aims and anonymous data collection and analyses. The answered questionnaires were either collected in a closed box in each diabetes center or could be sent anonymously via a prepaid envelope to the study administration center.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1144
• Est. completion date: December 31, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• mothers, fathers or other primary caregivers of children and adolescents diagnosed with type 1 diabetes before 14 years of age

• child's diabetes duration at least 12 months

• child's age under 19 years

Exclusion Criteria:

• caregivers unability to understand German language sufficiently

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Locations

Country	Name	City	State
Germany	Hannover Medical School	Hannover	Niedersachsen

Sponsors (10)

Lead Sponsor	Collaborator
Hannover Medical School	diabetesDE-Deutsche Diabetes Hilfe, Elisabeth-Krankenhaus Essen, Evangelisches Krankenhaus Bielefeld gGmbH, Katholisches Kinderkrankenhaus Wilhelmstift, Kinderärzte Mondstraße, Dr. med. Ralph Ziegler und Kollegen, Praxis für Kinder und Jugendmedizin, Kinderkrankenhaus auf der Bult, Leopoldina-Krankenhaus der Stadt Schweinfurt GmbH, Ruhr University of Bochum, Sana-Klinikum Lichtenberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	occupational situation of parents	questionnaire with 7 items to capture changes in occupational situation of parents after the onset of type 1 diabetes in their child	up to 12 weeks
Primary	number of participants reporting financial burden	questionnaire to capture changes in occupational situation of parents after the onset of type 1 diabetes in their child	up to 12 weeks
Secondary	number of participants reporting emotional and/or psychosocial burden	questionnaire to capture psychosocial and emotional burden of parents in the year following the diagnosis of diabetes in a child	up to 12 weeks