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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
196
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 : * Educative, family (patient and parent), at home * Psychological, with the patient individually * Medico-social orientation, group of patients
CHU de Fort de France
Fort-de-France-La Martinique, La Martinique, France
NOT_YET_RECRUITINGCentre Hospitalier Intercommunal de Creteil
Créteil, France
NOT_YET_RECRUITINGHôpital Mondor
Créteil, France
NOT_YET_RECRUITINGHôpital Bicêtre
Le Kremlin-Bicêtre, France
NOT_YET_RECRUITINGHospices Civils de Lyon
Lyon, France
RECRUITINGHôpital Européen Georges Pompidou
Paris, France
NOT_YET_RECRUITINGHôpital Necker
Paris, France
NOT_YET_RECRUITINGCentre Hospitalier de Pontoise
Pontoise, France
NOT_YET_RECRUITINGIncidence of sickle cell related severe complications leading to hospitalization
Number of hospital admission or emergency visit in the index hospital
Time frame: Within 24 months after transfer to the adult sector
Frequency of emergency visits in the index hospital
Frequency of emergency visits in the index hospital Within inclusion and transfer to the adult sector
Time frame: Up to 2 years
Frequency of emergency visits in the index hospital
Time frame: 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
Medication Intake Survey-Asthma (MIS-A) questionnaire score
Medication adherence evaluation at inclusion
Time frame: At inclusion
Medication Rating Scale (MARS) questionnaire score
Medication adherence evaluation at inclusion
Time frame: At inclusion
MIS-A questionnaire score
Medication adherence evaluation At transfer to the adult sector
Time frame: Up to 2 years
MARS questionnaire score
Medication adherence evaluation At transfer to the adult sector
Time frame: Up to 2 years
MIS-A questionnaire score
Medication adherence evaluation within 12 months after transfer to the adult sector
Time frame: within 12 months after transfer to the adult sector
MARS questionnaire score
This score will allow medication adherence evaluation within 12 months after transfer to the adult sector
Time frame: within 12 months after transfer to the adult sector
MIS-A questionnaire score
Medication adherence evaluation within 24 months after transfer to the adult sector
Time frame: within 24 months after transfer to the adult sector
MARS questionnaire score
Medication adherence evaluation within 24 months after transfer to the adult sector
Time frame: within 24 months after transfer to the adult sector
Number of days absent at school
Scholarly Absenteeism evaluation At transfer to the adult sector
Time frame: Up to 2 years
Number of days absent at school
Scholarly Absenteeism evaluation within 12 months after transfer to the adult sector
Time frame: within 12 months after transfer to the adult sector
Number of days absent at school
Scholarly Absenteeism evaluation within 24 months after transfer to the adult sector
Time frame: within 24 months after transfer to the adult sector
World Health Organization Quality of Life (WHOQOL) questionnaire score
Quality of Life evaluation At inclusion
Time frame: At inclusion
WHOQOL questionnaire score
Quality of Life evaluation At transfer to the adult sector
Time frame: Up to 2 years
WHOQOL questionnaire score
Quality of Life evaluation within 24 months after transfer to the adult sector
Time frame: within 24 months after transfer to the adult sector
EUropean Health Literacy questionnaire (HLS-EU-Q16) score
This will allow Health Literacy evaluation
Time frame: At inclusion
HLS-EU-Q16 score
Health Literacy evaluation At transfer to the adult sector
Time frame: Up to 2 years
HLS-EU-Q16 score
Health Literacy evaluation within 24 months after transfer to the adult sector
Time frame: within 24 months after transfer to the adult sector
Disease knowledge
Questionnaire developed for this study
Time frame: At inclusion
Disease knowledge
Questionnaire developed for this study
Time frame: Up to 2 years
Disease knowledge
Questionnaire developed for this study
Time frame: within 24 months after transfer to the adult sector
Patient activation measure-13 items questionnaire score
Patient activation At inclusion
Time frame: At inclusion
Patient activation measure-13 items questionnaire score
Patient activation At transfer to the adult sector
Time frame: Up to 2 years
Patient activation measure-13 items questionnaire score
Patient activation within 24 months after transfer to the adult sector
Time frame: within 24 months after transfer to the adult sector
Self efficacy specific instrument - sickle cell disease (SCD-SES) questionnaire score
Self efficacy evaluation at inclusion
Time frame: At inclusion
SCD-SES questionnaire score
Self efficacy evaluation At transfer to the adult sector
Time frame: Up to 2 years
SCD-SES questionnaire score
Self efficacy evaluation within 24 months after transfer to the adult sector
Time frame: within 24 months after transfer to the adult sector
Transition readiness assessment questionnaire (TRAQ) questionnaire score
Transition readiness evaluation at inclusion
Time frame: At inclusion
TRAQ questionnaire score
Transition readiness evaluation At transfer to the adult sector
Time frame: Up to 2 years
TRAQ questionnaire score
Transition readiness evaluation within 24 months after transfer to the adult sector
Time frame: within 24 months after transfer to the adult sector
cost effectiveness ratio
Cost analysis at the end of the study
Time frame: Up to 4 years
number of pediatric-adult transition program sessions performed
number of interventions performed per patient and date of implementation At the end of the study
Time frame: Up to 4 years
type of pediatric-adult transition program sessions performed
type of interventions performed per patient and date of implementation At the end of the study
Time frame: Up to 4 years
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