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Completed

NCT Number: NCT04814849

Parents' Occupation After Diabetes Onset

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Hannover Medical School

Hanover, Lower Saxony, 30625, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. occupational situation of parents

    Time frame: up to 12 weeks

    questionnaire with 7 items to capture changes in occupational situation of parents after the onset of type 1 diabetes in their child

  2. number of participants reporting financial burden

    Time frame: up to 12 weeks

    questionnaire to capture changes in occupational situation of parents after the onset of type 1 diabetes in their child

Secondary outcomes

  1. number of participants reporting emotional and/or psychosocial burden

    Time frame: up to 12 weeks

    questionnaire to capture psychosocial and emotional burden of parents in the year following the diagnosis of diabetes in a child

Sponsors and collaborators

Lead sponsor

Hannover Medical School

Other

Collaborators

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

Registry information

Official study title

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

Acronym: AMBA

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 24, 2021
Registry last updated
Mar 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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