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 (CROQUIE)
Primary Purpose
Chronic Disease
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Quality of life questionnaire
Sponsored by
About this trial
This is an interventional other trial for Chronic Disease
Eligibility Criteria
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
Sites / Locations
- Assistance Publique Hopitaux de MarseilleRecruiting
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04733391
First Posted
January 27, 2021
Last Updated
January 27, 2021
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT04733391
Brief 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
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 10, 2020 (Actual)
Primary Completion Date
July 31, 2021 (Anticipated)
Study Completion Date
July 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Quality of life questionnaire
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emilie Garrido-Pradalié, Research Director
Email
drci@ap-hm.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Castets
Email
sarah.castets@ap-hm.fr
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Castets, MD
Email
sarah.castets@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
jean christophe DUBUS
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
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