- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03786549
Pediatric -Adult Care Transition Program of Patients With Sickle Cell Disease (DREPADO)
Impact of a Pediatric-adult Care Transition Program on the Health Status of Patients With Sickle Cell Disease - A Randomized Controlled Trial
Background The pediatric-adult care transition is a risk-disrupting time for patients with chronic disease. This care transition takes place during adolescence; a period of psychological upheavals and adaptations of family roles. During this period, medication adherence is non-optimal and absenteeism at medical appointments is high.
Sickle cell disease (SCD) is the first genetic disease detected in France. It is chronic disease characterized by frequent painful vaso-occlusive crises (VOC) requiring emergency hospitalization when they are severe. Other serious complications are acute chest syndromes (ACS) and stroke.
In order to improve the health status of teenagers with sickle cell disease, it is necessary to anticipate this care transition and to involve the pediatric and adult sectors. The biopsychosocial health approach and the Social-Ecological Model of Adolescent and Young Adult Readiness to Transition (SMART) describe a care transition integrating bioclinical and psychosocial factors such as integration of the patient's family, education on disease and therapeutics, psychological management of pain and medico-social orientation.
The pediatric-adult transition program proposed is based on this biopsychosocial approach. It aims to improve the health status of adolescents with SCD, their quality of life and the use of health care service.
Objective of the study To assess the impact of a pediatric-adult transition program on the incidence of sickle-cell-related complications leading to hospitalization on 24-months after transfer to the adult sector.
The evaluation focuses on severe complications leading to hospitalization, such as VOC, ACS, and stroke.
Study design Multicenter Open-label individual Randomized Controlled Trial Population : Patients aged at least 16 years old with sickle cell disease, and their parents (or legal representatives Number of subject : 196 patients (98 patients by arm) The study will last 24 months Expected results For patients and families Better health and quality of life for patients is expected, including better use of medical care after the transition program. It is also expected a better experience of the pediatric-adult care transition and indirectly a better experience of intrafamilial relations.
For health professionals This project is expected to provide solutions to improve the pediatric-adult care transition of patients with chronic disease. Indeed, the methodological quality of the study will make it possible to evaluate the efficiency of the proposed program, to possibly adapt it and test it to other chronic diseases presenting the same care transition problematic.
In terms of public health SCD mainly affects populations of sub-Saharan origin, with low visibility and high social vulnerability. By focusing on this population, this project will reduce the social inequalities in health, experienced by patients with SCD and their families.
By improving the health, quality of life and care of patients with SCD, this project is expected to decrease the cost of the pediatric-adult care transition period.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Alexandra GAUTHIER VASSEROT, DR
- Phone Number: +33 04 69 16 65 72
- Email: alexandra.gauthier@ihope.fr
Study Contact Backup
- Name: Sandrine TOUZET, Dr
- Phone Number: +33 04 72 11 57 61
- Email: sandrine.touzet@chu-lyon.fr
Study Locations
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Créteil, France
- Not yet recruiting
- Centre Hospitalier Intercommunal de Créteil
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Contact:
- Corinne Pondarre
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Principal Investigator:
- Corinne Pondarré
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Créteil, France
- Not yet recruiting
- Hôpital Mondor
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Contact:
- Frédéric Galactéros
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Principal Investigator:
- Frédéric Galactéros
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Le Kremlin-Bicêtre, France
- Not yet recruiting
- Hôpital BICETRE
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Contact:
- Corinne Guitton
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Principal Investigator:
- Corinne Guitton
-
Principal Investigator:
- Christelle Chantalat
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Lyon, France
- Recruiting
- Hospices Civils de Lyon
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Principal Investigator:
- Giovanna Cannas
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Contact:
- Alexandra Gauthier- Vasserot
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Contact:
- Giovanna Cannas
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Principal Investigator:
- Alexandra Gauthier- Vasserot
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Paris, France
- Not yet recruiting
- Hopital Europeen Georges Pompidou
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Contact:
- Jean- Benoît Arlet
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Principal Investigator:
- Jean- Benoît Arlet
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Paris, France
- Not yet recruiting
- Hôpital Necker
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Contact:
- Marianne de Montalembert
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Principal Investigator:
- Marianne De Montalembert
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Pontoise, France
- Not yet recruiting
- Centre Hospitalier de Pontoise
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Contact:
- Stéphanie Eyssette- Guerreau
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Principal Investigator:
- Stéphanie Eyssette- Guerreau
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Principal Investigator:
- Laurent Blum
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La Martinique
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Fort-de-France-La Martinique, La Martinique, France
- Not yet recruiting
- CHU de Fort de France
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Contact:
- Gisèle ELANA, MD
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Principal Investigator:
- Gisèle ELANA
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
For patients :
- Age: 16-17 years,
- With major sickle cell syndrome, defined by hemoglobinopathy of homozygosity SS, or double heterozygosity SC or Sβ-thalassemia,
- Benefiting from social insurance of the type "Affection of long duration" (ALD).
For family members :
- Included children's parents or legal representatives,
- Accepting to participate in the study and having signed the informed consent.
Exclusion Criteria:
- Presenting a cognitive or psychiatric disorder known and major that may hinder interventions or evaluation, the judgment of the investigator, and / or having a family history with this type of disorders,
- Cured of SCD by an allograft of hematopoietic stem cells.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Patients included in this arm wil have usual follow-up.
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Experimental: Care transitional program
Patients included in this arm will get a care transitional program. Three structured axes of multidisciplinary interventions are added to the usual follow-up for the patients drawn in this interventional arm. Those axes integrate the bioclinical medical care and include the parents of the adolescent Three axes are :
|
Three structured axes of multidisciplinary interventions are added to the usual follow-up for the patients drawn in this interventional arm. Those axes integrate the bioclinical medical care and include the parents of the adolescent Three axes are :
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of sickle cell related severe complications leading to hospitalization
Time Frame: Within 24 months after transfer to the adult sector
|
Number of hospital admission or emergency visit in the index hospital
|
Within 24 months after transfer to the adult sector
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of emergency visits in the index hospital
Time Frame: Up to 2 years
|
Frequency of emergency visits in the index hospital Within inclusion and transfer to the adult sector
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Up to 2 years
|
Frequency of emergency visits in the index hospital
Time Frame: Within 12 months after transfer to the adult sector
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Within 12 months after transfer to the adult sector
|
|
Frequency of emergency visits in the index hospital
Time Frame: Within 12 and 24 months after transfer to the adult sector
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Within 12 and 24 months after transfer to the adult sector
|
|
Medication Intake Survey-Asthma (MIS-A) questionnaire score
Time Frame: At inclusion
|
Medication adherence evaluation at inclusion
|
At inclusion
|
Medication Rating Scale (MARS) questionnaire score
Time Frame: At inclusion
|
Medication adherence evaluation at inclusion
|
At inclusion
|
MIS-A questionnaire score
Time Frame: Up to 2 years
|
Medication adherence evaluation At transfer to the adult sector
|
Up to 2 years
|
MARS questionnaire score
Time Frame: Up to 2 years
|
Medication adherence evaluation At transfer to the adult sector
|
Up to 2 years
|
MIS-A questionnaire score
Time Frame: within 12 months after transfer to the adult sector
|
Medication adherence evaluation within 12 months after transfer to the adult sector
|
within 12 months after transfer to the adult sector
|
MARS questionnaire score
Time Frame: within 12 months after transfer to the adult sector
|
This score will allow medication adherence evaluation within 12 months after transfer to the adult sector
|
within 12 months after transfer to the adult sector
|
MIS-A questionnaire score
Time Frame: within 24 months after transfer to the adult sector
|
Medication adherence evaluation within 24 months after transfer to the adult sector
|
within 24 months after transfer to the adult sector
|
MARS questionnaire score
Time Frame: within 24 months after transfer to the adult sector
|
Medication adherence evaluation within 24 months after transfer to the adult sector
|
within 24 months after transfer to the adult sector
|
Number of days absent at school
Time Frame: Up to 2 years
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Scholarly Absenteeism evaluation At transfer to the adult sector
|
Up to 2 years
|
Number of days absent at school
Time Frame: within 12 months after transfer to the adult sector
|
Scholarly Absenteeism evaluation within 12 months after transfer to the adult sector
|
within 12 months after transfer to the adult sector
|
Number of days absent at school
Time Frame: within 24 months after transfer to the adult sector
|
Scholarly Absenteeism evaluation within 24 months after transfer to the adult sector
|
within 24 months after transfer to the adult sector
|
World Health Organization Quality of Life (WHOQOL) questionnaire score
Time Frame: At inclusion
|
Quality of Life evaluation At inclusion
|
At inclusion
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WHOQOL questionnaire score
Time Frame: Up to 2 years
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Quality of Life evaluation At transfer to the adult sector
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Up to 2 years
|
WHOQOL questionnaire score
Time Frame: within 24 months after transfer to the adult sector
|
Quality of Life evaluation within 24 months after transfer to the adult sector
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within 24 months after transfer to the adult sector
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EUropean Health Literacy questionnaire (HLS-EU-Q16) score
Time Frame: At inclusion
|
This will allow Health Literacy evaluation
|
At inclusion
|
HLS-EU-Q16 score
Time Frame: Up to 2 years
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Health Literacy evaluation At transfer to the adult sector
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Up to 2 years
|
HLS-EU-Q16 score
Time Frame: within 24 months after transfer to the adult sector
|
Health Literacy evaluation within 24 months after transfer to the adult sector
|
within 24 months after transfer to the adult sector
|
Disease knowledge
Time Frame: At inclusion
|
Questionnaire developed for this study
|
At inclusion
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Disease knowledge
Time Frame: Up to 2 years
|
Questionnaire developed for this study
|
Up to 2 years
|
Disease knowledge
Time Frame: within 24 months after transfer to the adult sector
|
Questionnaire developed for this study
|
within 24 months after transfer to the adult sector
|
Patient activation measure-13 items questionnaire score
Time Frame: At inclusion
|
Patient activation At inclusion
|
At inclusion
|
Patient activation measure-13 items questionnaire score
Time Frame: Up to 2 years
|
Patient activation At transfer to the adult sector
|
Up to 2 years
|
Patient activation measure-13 items questionnaire score
Time Frame: within 24 months after transfer to the adult sector
|
Patient activation within 24 months after transfer to the adult sector
|
within 24 months after transfer to the adult sector
|
Self efficacy specific instrument - sickle cell disease (SCD-SES) questionnaire score
Time Frame: At inclusion
|
Self efficacy evaluation at inclusion
|
At inclusion
|
SCD-SES questionnaire score
Time Frame: Up to 2 years
|
Self efficacy evaluation At transfer to the adult sector
|
Up to 2 years
|
SCD-SES questionnaire score
Time Frame: within 24 months after transfer to the adult sector
|
Self efficacy evaluation within 24 months after transfer to the adult sector
|
within 24 months after transfer to the adult sector
|
Transition readiness assessment questionnaire (TRAQ) questionnaire score
Time Frame: At inclusion
|
Transition readiness evaluation at inclusion
|
At inclusion
|
TRAQ questionnaire score
Time Frame: Up to 2 years
|
Transition readiness evaluation At transfer to the adult sector
|
Up to 2 years
|
TRAQ questionnaire score
Time Frame: within 24 months after transfer to the adult sector
|
Transition readiness evaluation within 24 months after transfer to the adult sector
|
within 24 months after transfer to the adult sector
|
cost effectiveness ratio
Time Frame: Up to 4 years
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Cost analysis at the end of the study
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Up to 4 years
|
number of pediatric-adult transition program sessions performed
Time Frame: Up to 4 years
|
number of interventions performed per patient and date of implementation At the end of the study
|
Up to 4 years
|
type of pediatric-adult transition program sessions performed
Time Frame: Up to 4 years
|
type of interventions performed per patient and date of implementation At the end of the study
|
Up to 4 years
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL18_0039
- 2018-A02198-47 (Other Identifier: ID RCB Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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