NCT04733391

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 10, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 2, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

February 2, 2021

Status Verified

January 1, 2021

Enrollment Period

1.1 years

First QC Date

January 27, 2021

Last Update Submit

January 27, 2021

Conditions

Chronic Disease

Outcome Measures

Primary Outcomes (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

Interventions

Quality of life questionnaireOTHER

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.

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Problems understanding the questionnaire (intellectual disability, low French proficiency)
  • No social security coverage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

RECRUITING

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Emilie Garrido-Pradalié, Research Director

CONTACT

drci@ap-hm.fr

Sarah Castets

CONTACT

sarah.castets@ap-hm.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2021

First Posted

February 2, 2021

Study Start

July 10, 2020

Primary Completion

July 31, 2021

Study Completion

July 31, 2021

Last Updated

February 2, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)