Anemia, Sickle CellDrépanoNCT02022891
Systematic Psychological and Medical Care for Children With SCD
An observational study of Anemia, Sickle Cell, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Sickle cell disease (SCD), a genetically transmitted blood disease, necessitates life-long care. In children, the disease may cause intense pain and other severe complications. Studies show that sources of stress, as well as complex psychological and intercultural issues associated with SCD, often aggravate symptoms. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Anemia, Sickle Cell
- What is being tested?
- systematic psychological care
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2013to May 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
- No healthy volunteers
- Child, Adult
Study population: children with sickle cell disease
Who may be able to join
- children with sickle cell disease
- treated in one of the three investigational centers
- All major forms of the disease will be studied regardless of the country of origin.
Who cannot join
- Refusal of the parents or the child to participate.
- Child or parent living in France for less than 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Systematic Psychological and Medical Care for Treatment of Pediatric Patients With SCD: : A Luxury or a Necessity?
Sickle cell disease (SCD), a genetically transmitted blood disease, necessitates life-long care. In children, the disease may cause intense pain and other severe complications. Studies show that sources of stress, as well as complex psychological and intercultural issues associated with SCD, often aggravate symptoms. At Louis Mourier hospital, the treatment model used is systematic psychological and medical care. Our hypothesis is that this care is beneficial for both the children and their families as seen in improved quality of life and positive impact on medical symptoms.
Read the detailed description
In this observational multicentric pilot study, our goal is to assess the effectiveness of a systematic medical-psychological approach in place for the past 6 years at the Louis Mourier Hospital, as compared to the usual practice in 2 other pediatric hospitals for SCD which focus essentially on the medical issues associated with SCD. Two psychologists will interview 80 children and their primary care-takers at Louis Mourier hospital, and 80 children and their care-takers of the other two centers, using a standard comprehensive care for SCD. For the parents, we propose to use a semi-structured interview including a prepared interview guide, the Loneliness Questionnaire, and the parents' version of KIDSCREEN (10 items). For the children, according to their age, The Rey-Osterrieth Complex Figure Test (ROCF), the Draw a Person in the Rain Test (DPR), the KIDSCREEN questionnaire, and semi-directed interview will be used. Relevant information from the patients' medical record directly related to the symptomatic expression of the SCD will be noted on a data collection form. This phase is scheduled to last 12 months. A statistical and qualitative analysis of the results will be carried out at the end of the study.
- Conditions
- Anemia, Sickle Cell
- Being tested
- systematic psychological care
- Keywords
- Sickle cell disease, psychological support, quality of life
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
systematic psychological careBehavioural
Prevention treatment plan that provides systematic medical and psychological care at routine pediatric consultations for SCD. Bio-psychosocial paradigm applied at pediatric consultations.
| Study group | Role | What they receive |
|---|---|---|
| systematic psychological care | Systematic psychological treatment plan added to medical care for children with SCD. Bio-psychosocial paradigm applied at pediatric consultations. | |
| Control | medical care only at routine pediatric consultations for SCD. Psychological support provided only when the pediatrician consider it appropriate. Receives: Behavioral: systematic psychological care |
What is being measured
The primary outcome is the main question the study is designed to answer.
psychological assessment and quality of life (quantitative and qualitative assessment)
quality of life (scales, semi-directive interviews, drawings), psychological assessment of the children and their parent
Measured: baseline
Secondary outcomes (1)
use of care-facilities: comparison between groups
retrospective (back to 2006) collection of the number of hospitalizations (with mean length of stay) and number of emergency care experiences (and reasons) , number of children requiring the support of other care professionals for their SCD (Medico-Psychological center, orthophonist, neuro-pediatrician, psychologist..)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study startJan 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia, Sickle CellStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Marie-Hélène ODIEVRE, MD, Principal investigator, Hôpital Louis Mourier, Colombes, France 92
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02022891
- Sponsor's protocol ID
- SC_MOE_2012-6
- Acronym
- Drépano
- Status last verified
- Aug 2014
- First submitted
- 28 Aug 2013
- Last updated
- 6 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Systematic Psychological and Medical Care for Treatment of Pediatric Patients With SCD: : A Luxury or a Necessity?
- ClinicalTrials.gov ID
- NCT02022891
- Acronym / sponsor ID
- Drépano / SC_MOE_2012-6
- Conditions
- Anemia, Sickle Cell
- Keywords
- Sickle cell disease, psychological support, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- Jan 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 30 Dec 2013 (estimated)
- 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), a genetically transmitted blood disease, necessitates life-long care. In children, the disease may cause intense pain and other severe complications. Studies show that sources of stress, as well as complex psychological and intercultural issues associated with SCD, often aggravate symptoms. At Louis Mourier hospital, the treatment model used is systematic psychological and medical care. Our hypothesis is that this care is beneficial for both the children and their families as seen in improved quality of life and positive impact on medical symptoms.
Detailed description
In this observational multicentric pilot study, our goal is to assess the effectiveness of a systematic medical-psychological approach in place for the past 6 years at the Louis Mourier Hospital, as compared to the usual practice in 2 other pediatric hospitals for SCD which focus essentially on the medical issues associated with SCD. Two psychologists will interview 80 children and their primary care-takers at Louis Mourier hospital, and 80 children and their care-takers of the other two centers, using a standard comprehensive care for SCD. For the parents, we propose to use a semi-structured interview including a prepared interview guide, the Loneliness Questionnaire, and the parents' version of KIDSCREEN (10 items). For the children, according to their age, The Rey-Osterrieth Complex Figure Test (ROCF), the Draw a Person in the Rain Test (DPR), the KIDSCREEN questionnaire, and semi-directed interview will be used. Relevant information from the patients' medical record directly related to the symptomatic expression of the SCD will be noted on a data collection form. This phase is scheduled to last 12 months. A statistical and qualitative analysis of the results will be carried out at the end of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| systematic psychological care | – | –Systematic psychological treatment plan added to medical care for children with SCD. Bio-psychosocial paradigm applied at pediatric consultations. |
| Control | – | Behavioral: systematic psychological caremedical care only at routine pediatric consultations for SCD. Psychological support provided only when the pediatrician consider it appropriate. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- children with sickle cell disease
Key inclusion criteria (3 listed)
- children with sickle cell disease
- treated in one of the three investigational centers
- All major forms of the disease will be studied regardless of the country of origin.
Key exclusion criteria (2 listed)
- Refusal of the parents or the child to participate.
- Child or parent living in France for less than 6 months
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 |
|---|---|---|
| systematic psychological carePrevention treatment plan that provides systematic medical and psychological care at routine pediatric consultations for SCD. Bio-psychosocial paradigm applied at pediatric consultations. | Behavioural | Control |
Primary outcome
psychological assessment and quality of life (quantitative and qualitative assessment)
Time frame: baseline
quality of life (scales, semi-directive interviews, drawings), psychological assessment of the children and their parent
1 secondary outcome
use of care-facilities: comparison between groups
Time frame: baseline
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 6 Aug 2014.
Related trials for Anemia, Sickle Cell
Active, not recruitingPhase 1/2
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Long-term Mitapivat Dosing in Subjects With Stable Sickle Cell Disease: An Extension of a Phase I Pilot Study of Mitapivat
Sickle Cell Disease, Hemolytic Anemia
RecruitingObservational study
HPC Offered for PRESERVE Expansion
Bone Marrow Transplant (BMT)
RecruitingPhase 1
Study to Evaluate the Safety and Tolerability of Escalating Doses of Fostamatinib in Subjects With Stable Sickle Cell Disease
Sickle Cell Disorders, Sickle Cell Disease
RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Not yet recruitingPhase 1
Buprenorphine for the Management of Pain in Children With Sickle Cell Disease
Sickle Cell Disease (SCD), Sickle Cell Disease Vaso-occlusive Crisis
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.
Marie-Hélène ODIEVRE, MD principal investigator
Hôpital Louis Mourier, Colombes, France 92
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia, Sickle Cell, run by Fondation Ophtalmologique Adolphe de Rothschild 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 3 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 6 Aug 2014. 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?
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?
psychological assessment and quality of life (quantitative and qualitative assessment) (time frame: baseline). 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 6 Aug 2014.