Clinical trial NCT04814849: Parents' Occupation After Diabetes Onset
Official title: Long-term Occupational Consequences for Families of Children With Type 1 Diabetes: the Mothers Take the Burden
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Keywords: type 1 diabetes, parents, occupation, gender inequality
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
Collaborators: name: diabetesDE-Deutsche Diabetes Hilfe
name: Sana-Klinikum Lichtenberg
name: Kinderkrankenhaus auf der Bult
name: Katholisches Kinderkrankenhaus Wilhelmstift
name: Evangelisches Krankenhaus Bielefeld gGmbH
name: Elisabeth-Krankenhaus Essen
name: Ruhr University of Bochum
name: Leopoldina-Krankenhaus der Stadt Schweinfurt GmbH
name: Kinderärzte Mondstraße, Dr. med. Ralph Ziegler und Kollegen, Praxis für Kinder und Jugendmedizin
First posted: 2021-03-24
Enrollment: 1144
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: CROSS_SECTIONAL
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: occupational situation of parents
timeFrame: up to 12 weeks
measure: number of participants reporting financial burden
timeFrame: up to 12 weeks
Secondary outcomes:
measure: number of participants reporting emotional and/or psychosocial burden
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School
state: Niedersachsen
Study officials:
affiliation: Hannover Medical School
name: Karin Lange, PhD
role: STUDY_DIRECTOR
References: