Informations générales (source: ClinicalTrials.gov)
Impact of a Pediatric-adult Care Transition Program on the Health Status of Patients With Sickle Cell Disease - A Randomized Controlled Trial (DREPADO)
Interventional
N/A
Hospices Civils de Lyon (Voir sur ClinicalTrials)
janvier 2019
avril 2027
25 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Cécile ARNAUD | 17/05/2024 08:11:32 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Europeen Georges Pompidou | Jean- Benoît Arlet | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Necker-Enfants Malades | Marianne De Montalembert | Contact (sur clinicalTrials) | |||
| HOPITAL NOVO | Stéphanie Eyssette- Guerreau | Contact (sur clinicalTrials) | |||
| IFSI DE L'HÔPITAL BICÊTRE | Corinne Guitton | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Hospices Civils de Lyon - Lyon - France | Alexandra Gauthier- Vasserot | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU de Fort de France - Fort-de-France-La Martinique - La Martinique - France | Gisèle ELANA, MD | Contact (sur clinicalTrials) | |||
| Hôpital Mondor - Créteil - France | Frédéric Galactéros | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
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.
- 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.