Sickle Cell DiseaseNCT03975699
Implications of a Paediatrician-psychologist Tandem for Sickle Cell Disease Care and Impact on Cognitive Functioning
An observational study of Sickle Cell Disease, run by Fondation Ophtalmologique Adolphe de Rothschild.
Trial summary
Sickle cell disease (SCD) necessitates a paediatric treatment plan that considers the influence of psychological, family and intercultural factors. At the Louis-Mourier Hospital (APHP) in Colombes, France, a paediatric-psychological partnership where a clinical psychologist accompanies the paediatrician at programmed… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Assessment of psychological repercussions of SCD
- How many people
- 155 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to Apr 2014
- Phase
- Observational
- 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 Up to 18 years
- All sexes
- Child, Adult
Study population: Children suffering from SCD and their parents, consulting in one of the 3 hospitals.
Who may be able to join
- Children under 18 years old
- Major form of SCD (SS, SC, Sβ° thal, Sβ+ thal) diagnosed by electrophoresis
Who cannot join
- Child or parent residing in France less than 6 months
- Having received SCD treatment in more than one centre
About this study
Sickle cell disease (SCD) necessitates a paediatric treatment plan that considers the influence of psychological, family and intercultural factors. At the Louis-Mourier Hospital (APHP) in Colombes, France, a paediatric-psychological partnership where a clinical psychologist accompanies the paediatrician at programmed consultations was introduced.
The psychological repercussions of SCD were assessed among children and their parents treated in Colombes and in two other paediatric units without a paediatric-psychological partnership.
- Conditions
- Sickle Cell Disease
- Being tested
- Assessment of psychological repercussions of SCD
- Keywords
- paediatric-psychological partnership, child, mental health, integrated care, well-being
- Medical subject headings
- Anemia, Sickle Cell, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of psychological repercussions of SCDOther
Quantitative relevant data culled from medical files and qualitative analysis based on data gathered from child and parent interviews, were collected in the three hospitals.
| Study group | Role | What they receive |
|---|---|---|
| Patients in centre 1: Louis-Mourier Hospital | All SCD follow-up consultations were conducted jointly by a paediatrician and a clinical psychologist. Receives: Other: Assessment of psychological repercussions of SCD | |
| Patients in centre 2: Evry hospital | All SCD follow-up consultations were conducted by a paediatrician alone. The unit had close links with the local psycho-medical paediatric care centre when specialized referrals were necessary. Receives: Other: Assessment of psychological repercussions of SCD | |
| Patients in centre 3: Clamart hospital | All SCD follow-up consultations were conducted by a paediatrician alone. Receives: Other: Assessment of psychological repercussions of SCD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rey-Osterrieth complex figure test scores (ROCF recall scores)
The Rey-Osterrieth complex figure test (ROCF) is a neuropsychological assessment in which patients are asked to reproduce a complicated line drawing, first by copying it freehand (recognition), and then drawing from memory (recall). Scoring of drawings is based on the widely used 36-point scoring system (0 being the worst score and 36 the best).
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 posted5 Jun 2019
- Study startFeb 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03975699
- Sponsor's protocol ID
- 29185057
- Status last verified
- Sep 2021
- First submitted
- 4 Jun 2019
- Last updated
- 17 Sep 2021
- Results posted
- 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 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implications of a Paediatrician-psychologist Tandem for Sickle Cell Disease Care and Impact on Cognitive Functioning
- ClinicalTrials.gov ID
- NCT03975699
- Acronym / sponsor ID
- 29185057
- Conditions
- Sickle Cell Disease
- Keywords
- paediatric-psychological partnership, child, mental health, integrated care, well-being
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- Feb 2013 (actual)
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 5 Jun 2019 (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.
Sickle cell disease (SCD) necessitates a paediatric treatment plan that considers the influence of psychological, family and intercultural factors. At the Louis-Mourier Hospital (APHP) in Colombes, France, a paediatric-psychological partnership where a clinical psychologist accompanies the paediatrician at programmed consultations was introduced.
The psychological repercussions of SCD were assessed among children and their parents treated in Colombes and in two other paediatric units without a paediatric-psychological partnership.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients in centre 1: Louis-Mourier Hospital | – | Other: Assessment of psychological repercussions of SCDAll SCD follow-up consultations were conducted jointly by a paediatrician and a clinical psychologist. |
| Patients in centre 2: Evry hospital | – | Other: Assessment of psychological repercussions of SCDAll SCD follow-up consultations were conducted by a paediatrician alone. The unit had close links with the local psycho-medical paediatric care centre when specialized referrals were necessary. |
| Patients in centre 3: Clamart hospital | – | Other: Assessment of psychological repercussions of SCDAll SCD follow-up consultations were conducted by a paediatrician alone. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children suffering from SCD and their parents, consulting in one of the 3 hospitals.
Key inclusion criteria (2 listed)
- Children under 18 years old
- Major form of SCD (SS, SC, Sβ° thal, Sβ+ thal) diagnosed by electrophoresis
Key exclusion criteria (2 listed)
- Child or parent residing in France less than 6 months
- Having received SCD treatment in more than one centre
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 |
|---|---|---|
| Assessment of psychological repercussions of SCDQuantitative relevant data culled from medical files and qualitative analysis based on data gathered from child and parent interviews, were collected in the three hospitals. | Other | Patients in centre 1: Louis-Mourier Hospital, Patients in centre 2: Evry hospital, Patients in centre 3: Clamart hospital |
Primary outcome
Rey-Osterrieth complex figure test scores (ROCF recall scores)
Time frame: 1 day
The Rey-Osterrieth complex figure test (ROCF) is a neuropsychological assessment in which patients are asked to reproduce a complicated line drawing, first by copying it freehand (recognition), and then drawing from memory (recall). Scoring of drawings is based on the widely used 36-point scoring system (0 being the worst score and 36 the best).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Disease, run by Fondation Ophtalmologique Adolphe de Rothschild.
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 2 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: finished, as of the sponsor's last update on 17 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rey-Osterrieth complex figure test scores (ROCF recall scores) (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 17 Sep 2021.