Adaption and Testing of the Quality of Life in Short Stature Youth (QoLISSY) Questionnaire for Parents With Children From 0-4
NCT ID: NCT05603936
Last Updated: 2022-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
168 participants
OBSERVATIONAL
2022-03-01
2023-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evolution of the Quality of Life of Short Statured Children Treated With Growth Hormone : Evaluation at Adult Size
NCT05195437
Quality of Life and Psychosocial Dimension in Children With Hypopituitarism
NCT05403255
Special Use-results Surveillance on Long Term Use of Sogroya® in Children With Short Stature Due to Growth Hormone Deficiency Where Epiphysial Discs Are Not Closed
NCT06109935
A Study to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone in Children With Achondroplasia
NCT05353192
Growth Hormone Treatment in Children Born Small for Gestational Age: Assessment of Satisfaction
NCT00519844
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
In addition, it will be investigated whether, from the parents' point of view, other instruments are suitable for measuring the quality of life of their short statured children. Their preference regarding the instruments will be assessed so that a recommendation can be made as to which instruments are particularly suitable.
A systematic literature review will be conducted to identify suitable instruments to measure the quality of life of short statured children aged 0 to 4.
Approximately 10-20 parents of 0-4 year old children with ACH, GHD and SGA will be recruited for the qualitative data collection (n = 30 to 60). The patients will be recruited through the BKMF (German Association for People of Short Stature and their Families).
In order to test the psychometric properties of the instruments, approximately 30 parents (15 mothers / 15 fathers) of 0-4 year old children with ACH, GHD and SGA will be recruited for the quantitative part of the study (n = 90). All participants will be asked to complete the QoLISSY or other instruments found suitable in the pilot test. For the purpose of cross-validation, the PEDSQL will be used in parallel.
Two weeks after receiving the field test, the re-test will be sent to ensure the reliability of the study. The re-test will be administered to a minimum of 20% of the participants.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
CROSS_SECTIONAL
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Questionnaire
The original QOLISSY questionnaire was first developed in 2011, it is available as a patient reported and a parent reported instrument. It includes:
* QoLISSY questionnaire for children and adolescents (8-12, 13-18 yrs)
* QoLISSY questionnaire for parents of children with short stature (4-7, 8-12 and 13-18 yrs) The QoLISSY instrument can be used to assess the health-related quality of life in short stature youth regardless of its cause; however it was specifically developed for patients with GHD and ISS and their parents.The aim of the current study is the adaption, implementation and validation of the instrument for the investigation of the short stature specific quality of life (QoLISSY) for children (age 0-4 years) with achondroplasia (ACH), Small for Gestational Age (SGA) and Growth Hormone Deficiency (GHD) from a parental perspective.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Children older than 4 years of age
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bundesverband Kleinwüchsige Menschen und ihre Familien e.V.
UNKNOWN
Pfizer
INDUSTRY
Universitätsklinikum Hamburg-Eppendorf
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Julia Quitmann
Role: PRINCIPAL_INVESTIGATOR
Center for Psychosocial Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Medical Center Hamburg-Eppendorf
Hamburg, , Germany
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
QoLISSY 0-4
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.