Ignite Creation Date:
2024-05-06 @ 12:32 PM
Last Modification Date:
2024-10-26 @ 1:00 PM
Study NCT ID:
NCT03786549
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2018-12-13
Brief Title:
Pediatric -Adult Care Transition Program of Patients With Sickle Cell Disease
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Impact of a Pediatric-adult Care Transition Program on the Health Status of Patients With Sickle Cell Disease - A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DREPADO
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 patients 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
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 patients 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-A02198-47 | OTHER | ID RCB Number | None |