Effects of Delayed Growth on the Quality of Life of Children Treated for a Chronic Disease and Quality of Life Study of Their Parents and Siblings

Chronic Disease Clinical Trial

— CROQUIE  

Official title:

Effects of Delayed Growth on the Quality of Life of Children Treated for a Chronic Disease and Quality of Life Study of Their Parents and Siblings

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04733391
• Other study ID #: 2019-47
• Secondary ID: 2020-A00260-36
• Status: Recruiting
• Phase: N/A
• Start date: July 10, 2020
• Est. completion date: July 31, 2021

Study information

• Verified date: January 2021
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Emilie Garrido-Pradalié, Research Director
• Email: drci[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Chronic childhood diseases have sometimes strong repercussions on the everyday life of patients and their families, because of strict daily treatment regimens, physical limitation or effects on social life for instance In children, chronic diseases can lead to poor growth, which can of itself affect the child's quality of life.

Our proposal is therefore to study the effects of short stature on the quality of life of children with chronic diseases treated in our multidisciplinary paediatrics department.

The quality of life of the patients' relatives will also be considered.

Description:

Chronic childhood diseases have sometimes strong repercussions on the everyday life of patients and their families, because of strict daily treatment regimens, physical limitation or effects on social life for instance.

The importance of considering quality of life (an overarching concept covering the effects of the disease on physical, metal, emotional, social and behavioural well-being) in the treatment of patients with chronic conditions is now well established.

Quality of life studies often focus on a specific chronic condition. Studies of multiple chronic pathologies are rarer. However, factors such as the severity of the disease, its prognosis, the constraints of the daily regimen, and the visibility of the disease can have a greater impact than the type of disease itself. Studies of specific chronic diseases have identified several factors affecting quality of life such as age, sex, disease severity, medically unexplained symptoms, family cohesion, socio-economic status, perception of the disease, the adaptation strategies used by the child or their family… It would therefore be interesting to study the effects of these factors on chronic diseases in general, irrespective of disease type.

In children, chronic diseases can lead to poor growth, which can of itself affect the child's quality of life.

Our proposal is therefore to study the effects of short stature on the quality of life of children with chronic diseases treated in our multidisciplinary paediatrics department.

The quality of life of the patients' relatives will also be considered.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

Inclusion Criteria:

• Age between 8 and 18 years

• Treated in the multidisciplinary paediatrics department of the Timone Hospital

• With a chronic disease (ICD10 definition: for at least 3 months in the current year with no curative treatment available)

• For at least three months

• Requiring at least two hospital consultations per year

• Able to complete the questionnaire

• Able to speak French

• Child and parental consent

Exclusion Criteria:

• Problems understanding the questionnaire (intellectual disability, low French proficiency)

• No social security coverage

Related Conditions & MeSH terms

• Chronic Disease

Intervention

Other:
• Quality of life questionnaire
Quality of life will be evaluated using the "child" version of the VSP-A questionnaire, for patients aged 8-10 years and the "adolescent" version for those aged 11-17 years.

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the quality of life of children treated for a chronic disease. using the VSP-A questionnaire for children aged 11 to 18 years and the VSP-Ae questionnaire for children aged between 8 and 11 years.		1 day