Pediatric -Adult Care Transition Program of Patients With Sickle Cell Disease
- Conditions
- Sickle Cell Disease
- Interventions
- Other: pediatric-adult care transition program
- Registration Number
- NCT03786549
- Lead Sponsor
- Hospices Civils de Lyon
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 196
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Care transitional program pediatric-adult care transition 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 : * Educative, family (patient and parent), at home * Psychological, with the patient individually * Medico-social orientation, group of patients
- Primary Outcome Measures
Name Time Method Incidence of sickle cell related severe complications leading to hospitalization Within 24 months after transfer to the adult sector Number of hospital admission or emergency visit in the index hospital
- Secondary Outcome Measures
Name Time Method Medication Intake Survey-Asthma (MIS-A) questionnaire score At inclusion Medication adherence evaluation at inclusion
HLS-EU-Q16 score within 24 months after transfer to the adult sector Health Literacy evaluation within 24 months after transfer to the adult sector
Frequency of emergency visits in the index hospital Within 12 and 24 months after transfer to the adult sector Medication Rating Scale (MARS) questionnaire score At inclusion Medication adherence evaluation at inclusion
MIS-A questionnaire score within 24 months after transfer to the adult sector Medication adherence evaluation within 24 months after transfer to the adult sector
Self efficacy specific instrument - sickle cell disease (SCD-SES) questionnaire score At inclusion Self efficacy evaluation at inclusion
MARS questionnaire score within 24 months after transfer to the adult sector Medication adherence evaluation within 24 months after transfer to the adult sector
Number of days absent at school within 24 months after transfer to the adult sector Scholarly Absenteeism evaluation within 24 months after transfer to the adult sector
EUropean Health Literacy questionnaire (HLS-EU-Q16) score At inclusion This will allow Health Literacy evaluation
Patient activation measure-13 items questionnaire score within 24 months after transfer to the adult sector Patient activation within 24 months after transfer to the adult sector
number of pediatric-adult transition program sessions performed Up to 4 years number of interventions performed per patient and date of implementation At the end of the study
World Health Organization Quality of Life (WHOQOL) questionnaire score At inclusion Quality of Life evaluation At inclusion
Disease knowledge within 24 months after transfer to the adult sector Questionnaire developed for this study
SCD-SES questionnaire score within 24 months after transfer to the adult sector Self efficacy evaluation within 24 months after transfer to the adult sector
WHOQOL questionnaire score within 24 months after transfer to the adult sector Quality of Life evaluation within 24 months after transfer to the adult sector
Transition readiness assessment questionnaire (TRAQ) questionnaire score At inclusion Transition readiness evaluation at inclusion
type of pediatric-adult transition program sessions performed Up to 4 years type of interventions performed per patient and date of implementation At the end of the study
TRAQ questionnaire score within 24 months after transfer to the adult sector Transition readiness evaluation within 24 months after transfer to the adult sector
cost effectiveness ratio Up to 4 years Cost analysis at the end of the study
Trial Locations
- Locations (8)
Centre Hospitalier de Pontoise
🇫🇷Pontoise, France
CHU de Fort de France
🇫🇷Fort-de-France-La Martinique, La Martinique, France
Centre Hospitalier Intercommunal de Creteil
🇫🇷Créteil, France
Hôpital Mondor
🇫🇷Créteil, France
Hôpital Bicêtre
🇫🇷Le Kremlin-Bicêtre, France
Hôpital Necker
🇫🇷Paris, France
Hospices Civils de Lyon
🇫🇷Lyon, France
Hôpital Européen Georges Pompidou
🇫🇷Paris, France