Chronic DiseaseCROQUIENCT04733391
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
A study testing Quality of life questionnaire in people with Chronic Disease, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Chronic Disease
- What is being tested?
- Quality of life questionnaire
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jul 2020to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Problems understanding the questionnaire (intellectual disability, low French proficiency)
- No social security coverage
Trial locations and contacts
1 site in 1 country.
Emilie Garrido-Pradalié, Research Director contact
Sarah Castets contact
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hopitaux de Marseille
Marseille, 13354
Sarah Castets, MD, sarah.castets@ap-hm.fr
jean christophe DUBUS
About this study
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.
Read the 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.
- Conditions
- Chronic Disease
- Being tested
- Quality of life questionnaire
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start10 Jul 2020
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04733391
- Sponsor's protocol ID
- 2019-47
- Other IDs
- 2020-A00260-36
- Acronym
- CROQUIE
- Status last verified
- Jan 2021
- First submitted
- 27 Jan 2021
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04733391
- Acronym / sponsor ID
- CROQUIE / 2019-47
- Conditions
- Chronic Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 10 Jul 2020 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 2 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- Problems understanding the questionnaire (intellectual disability, low French proficiency)
- No social security coverage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality of life questionnaireQuality 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. | Other | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilie Garrido-Pradalié, Research Director contact
Sarah Castets contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality of life questionnaire in people with Chronic Disease, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emilie Garrido-Pradalié, Research Director (drci@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021; AzTrials last refreshed its copy on 8 Nov 2026.