Type 1 DiabetesAMBANCT04814849
Parents' Occupation After Diabetes Onset
An observational study of Type 1 Diabetes, run by Hannover Medical School at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 1 Diabetes
- How many people
- 1,144 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2017to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- caregivers unability to understand German language sufficiently
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 1 Diabetes
- Keywords
- type 1 diabetes, parents, occupation, gender inequality
- Medical subject headings
- Diabetes Mellitus, Type 1
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: up to 12 weeks
Secondary outcomes (1)
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
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start1 Dec 2017
- Primary completion30 Jun 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 1,144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- diabetesDE-Deutsche Diabetes Hilfe, Sana-Klinikum Lichtenberg, Kinderkrankenhaus auf der Bult, Katholisches Kinderkrankenhaus Wilhelmstift, Evangelisches Krankenhaus Bielefeld gGmbH, Elisabeth-Krankenhaus Essen, Ruhr University of Bochum, Leopoldina-Krankenhaus der Stadt Schweinfurt GmbH, Kinderärzte Mondstraße, Dr. med. Ralph Ziegler und Kollegen, Praxis für Kinder und Jugendmedizin
- Responsible party
- Principal investigator, Heike Saßmann, Dr., Hannover Medical School
- Investigators
- Karin Lange, PhD, Study director, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04814849
- Sponsor's protocol ID
- 260320597
- Acronym
- AMBA
- Status last verified
- Mar 2021
- First submitted
- 18 Mar 2021
- Last updated
- 24 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Occupational Consequences for Families of Children With Type 1 Diabetes: the Mothers Take the Burden
- ClinicalTrials.gov ID
- NCT04814849
- Acronym / sponsor ID
- AMBA / 260320597
- Conditions
- Type 1 Diabetes
- Keywords
- type 1 diabetes, parents, occupation, gender inequality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,144 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- diabetesDE-Deutsche Diabetes Hilfe, Sana-Klinikum Lichtenberg, Kinderkrankenhaus auf der Bult, Katholisches Kinderkrankenhaus Wilhelmstift, Evangelisches Krankenhaus Bielefeld gGmbH, Elisabeth-Krankenhaus Essen, Ruhr University of Bochum, Leopoldina-Krankenhaus der Stadt Schweinfurt GmbH, Kinderärzte Mondstraße, Dr. med. Ralph Ziegler und Kollegen, Praxis für Kinder und Jugendmedizin
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- caregivers unability to understand German language sufficiently
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
1 secondary outcome
number of participants reporting emotional and/or psychosocial burden
Time frame: up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karin Lange, PhD study director
Hannover Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occupational situation of parents (time frame: up to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2021.