Adaption and Testing of the Quality of Life in Short Stature Youth (QoLISSY) Questionnaire for Parents With Children From 0-4

NCT05603936 | Unknown

• 1 other identifier: QoLISSY 0-4
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the 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.

Conditions

Achondroplasia; Small for Gestational Age; Growth Hormone Deficiency

Keywords

Health related quality of life

Outcome Measures

Primary Outcomes (1)

• Health related quality of life measured by the adapted version of the QoLISSY questionnaire

  The studies aim is to identify factors influencing the health related quality of life of children with Achondroplaise, Growth Hormone Deficiency and Small for Gestational Age to adapt and test the QOLISSY-Questionnaire for children from the age of 0-4.

  June 2022 - March 2023

Interventions

Questionnaire OTHER

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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Parents of children aged 0-4 with the diagnosis Achondroplaisa, Short for Gestational Age or Growth Hormone Defiency

You may qualify if:

• Parents of children aged 0-4 with the diagnosis Achondroplaisa, Short for Gestational Age or Growth Hormone Defiency

You may not qualify if:

• Other diagnosis than Achondroplaisa, Short for Gestational Age or Growth Hormone Defiency
• Children older than 4 years of age

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• Bundesverband Kleinwüchsige Menschen und ihre Familien e.V.: collaborator
• Pfizer: collaborator

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

RECRUITING

MeSH Terms

Conditions

Achondroplasia; Dwarfism, Pituitary

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Osteochondrodysplasias; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Julia Quitmann

  Center for Psychosocial Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia Quitmann, Dipl. Psych.

CONTACT

+49 (040) 74 10 52 789; j.quitmann@uke.de

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 3, 2022
• Study Start: March 1, 2022
• Primary Completion: September 30, 2023
• Study Completion: December 31, 2023
• Last Updated: November 3, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)