CROQUIE: 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

Sponsor
Assistance Publique Hopitaux De Marseille (Other)
Overall Status
Recruiting
CT.gov ID
NCT04733391
Collaborator
(none)
200
1
12.7
15.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Quality of life questionnaire
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
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
Actual Study Start Date :
Jul 10, 2020
Anticipated Primary Completion Date :
Jul 31, 2021
Anticipated Study Completion Date :
Jul 31, 2021

Outcome Measures

Primary Outcome Measures

  1. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assistance Publique Hopitaux de Marseille Marseille France 13354

Sponsors and Collaborators

  • Assistance Publique Hopitaux De Marseille

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT04733391
Other Study ID Numbers:
  • 2019-47
  • 2020-A00260-36
First Posted:
Feb 2, 2021
Last Update Posted:
Feb 2, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 2, 2021