免费获得国外相关药品，最快 1 个工作日回馈药物信息
出境医 / 临床实验 / Implications of a Paediatrician-psychologist Tandem for Sickle Cell Disease Care and Impact on Cognitive Functioning
Implications of a Paediatrician-psychologist Tandem for Sickle Cell Disease Care and Impact on Cognitive Functioning
Study Description
Brief 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 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.
| Condition or disease | Intervention/treatment |
|---|---|
| Sickle Cell Disease | Other: Assessment of psychological repercussions of SCD |
Study Design
| Study Type : | Observational |
| Actual Enrollment : | 155 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Prospective |
| Official Title: | Implications of a Paediatrician-psychologist Tandem for Sickle Cell Disease Care and Impact on Cognitive Functioning |
| Actual Study Start Date : | February 2013 |
| Actual Primary Completion Date : | April 2014 |
| Actual Study Completion Date : | April 2014 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
Patients in centre 1: Louis-Mourier Hospital
All SCD follow-up consultations were conducted jointly by a paediatrician and a clinical psychologist.
|
Other: Assessment of psychological repercussions of SCD
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.
|
|
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.
|
Other: Assessment of psychological repercussions of SCD
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.
|
|
Patients in centre 3: Clamart hospital
All SCD follow-up consultations were conducted by a paediatrician alone.
|
Other: Assessment of psychological repercussions of SCD
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.
|
Outcome Measures
Primary Outcome Measures :
- ROCF recall scores (Rey-Osterrieth complex figure test) [ Time Frame: 1 day ]
Eligibility Criteria
| Ages Eligible for Study: | up to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Non-Probability Sample |
Study Population
Children suffering from SCD and their parents, consulting in one of the 3 hospitals.
Criteria
Inclusion Criteria:
- Children under 18 years old
- Major form of SCD (SS, SC, Sβ° thal, Sβ+ thal) diagnosed by electrophoresis
Exclusion Criteria:
- Child or parent residing in France less than 6 months
- Having received SCD treatment in more than one centre
Contacts and Locations
No Contacts or Locations Provided
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | June 4, 2019 | ||||
| First Posted Date | June 5, 2019 | ||||
| Last Update Posted Date | June 5, 2019 | ||||
| Actual Study Start Date | February 2013 | ||||
| Actual Primary Completion Date | April 2014 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
ROCF recall scores (Rey-Osterrieth complex figure test) [ Time Frame: 1 day ] | ||||
| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Implications of a Paediatrician-psychologist Tandem for Sickle Cell Disease Care and Impact on Cognitive Functioning | ||||
| Official Title | Implications of a Paediatrician-psychologist Tandem for Sickle Cell Disease Care and Impact on Cognitive Functioning | ||||
| Brief 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 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. |
||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Case-Control Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Children suffering from SCD and their parents, consulting in one of the 3 hospitals. | ||||
| Condition | Sickle Cell Disease | ||||
| Intervention | Other: Assessment of psychological repercussions of SCD
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 Groups/Cohorts |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
155 | ||||
| Original Actual Enrollment | Same as current | ||||
| Actual Study Completion Date | April 2014 | ||||
| Actual Primary Completion Date | April 2014 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
||||
| Sex/Gender |
|
||||
| Ages | up to 18 Years (Child, Adult) | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Not Provided | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03975699 | ||||
| Other Study ID Numbers | 29185057 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
|
||||
| IPD Sharing Statement |
|
||||
| Responsible Party | Fondation Ophtalmologique Adolphe de Rothschild | ||||
| Study Sponsor | Fondation Ophtalmologique Adolphe de Rothschild | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | Fondation Ophtalmologique Adolphe de Rothschild | ||||
| Verification Date | June 2019 | ||||
