Parents' Occupation After Diabetes Onset (AMBA)

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

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 1144

Contacts and Locations

Study Locations

• Germany
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30625
      • Hannover Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Of 1470 eligible families in the nine centers, 1192 (81% response rate) agreed to participate and answered the questionnaire. The majority of respondents to the questionnaire were mothers (n = 939; 82%). Overall 48 questionnaires had to be excluded due to a high number of missing data. Thus, the final sample consisted of n = 1144 answered questionnaires with information about both parents' occupational situation.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Family-Based
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hannover Medical School
• Collaborators: Ruhr University of Bochum; Evangelisches Krankenhaus Bielefeld gGmbH; Kinderkrankenhaus auf der Bult; diabetesDE-Deutsche Diabetes Hilfe; Sana-Klinikum Lichtenberg; Katholisches Kinderkrankenhaus Wilhelmstift; Elisabeth-Krankenhaus Essen; Leopoldina-Krankenhaus der Stadt Schweinfurt GmbH; Kinderärzte Mondstraße, Dr. med. Ralph Ziegler und Kollegen, Praxis für Kinder und Jugendmedizin
• Investigators: Study Director: Karin Lange, PhD, Hannover Medical School

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: March 18, 2021
• First Submitted That Met QC Criteria: March 23, 2021
• First Posted (Actual): March 24, 2021

Study Record Updates

• Last Update Posted (Actual): March 24, 2021
• Last Update Submitted That Met QC Criteria: March 23, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: type 1 diabetes, parents, occupation, gender inequality
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 260320597

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No