NCT04814849

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,144

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
Last Updated

March 24, 2021

Status Verified

March 1, 2021

Enrollment Period

7 months

First QC Date

March 18, 2021

Last Update Submit

March 23, 2021

Conditions

Keywords

type 1 diabetes, parents, occupation, gender inequality

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • number of participants reporting emotional and/or psychosocial burden

    up to 12 weeks

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • caregivers unability to understand German language sufficiently

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hannover Medical School

Hanover, Lower Saxony, 30625, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Karin Lange, PhD

    Hannover Medical School

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Heike Saßmann

Study Record Dates

First Submitted

March 18, 2021

First Posted

March 24, 2021

Study Start

December 1, 2017

Primary Completion

June 30, 2018

Study Completion

December 31, 2018

Last Updated

March 24, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations