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)

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Disease
• Intervention / Treatment: Other: Quality of life questionnaire

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emilie Garrido-Pradalié, Research Director; Email: drci@ap-hm.fr
• Study Contact Backup: Name: Sarah Castets; Email: sarah.castets@ap-hm.fr

Study Locations

• France
  • Marseille, France, 13354
    • Recruiting
    • Assistance Publique Hopitaux de Marseille
    • Contact: Sarah Castets, MD; Email: sarah.castets@ap-hm.fr
    • Sub-Investigator: jean christophe DUBUS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2020
• Primary Completion (Anticipated): July 31, 2021
• Study Completion (Anticipated): July 31, 2021

Study Registration Dates

• First Submitted: January 27, 2021
• First Submitted That Met QC Criteria: January 27, 2021
• First Posted (Actual): February 2, 2021

Study Record Updates

• Last Update Posted (Actual): February 2, 2021
• Last Update Submitted That Met QC Criteria: January 27, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: 2019-47; 2020-A00260-36 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No