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
2 other identifiers
interventional
196
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2019
Longer than P75 for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2018
CompletedFirst Posted
Study publicly available on registry
December 26, 2018
CompletedStudy Start
First participant enrolled
January 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 16, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 16, 2027
June 21, 2024
June 1, 2024
8.3 years
December 13, 2018
June 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of sickle cell related severe complications leading to hospitalization
Number of hospital admission or emergency visit in the index hospital
Within 24 months after transfer to the adult sector
Secondary Outcomes (35)
Frequency of emergency visits in the index hospital
Up to 2 years
Frequency of emergency visits in the index hospital
Within 12 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 Intake Survey-Asthma (MIS-A) questionnaire score
At inclusion
Medication Rating Scale (MARS) questionnaire score
At inclusion
- +30 more secondary outcomes
Study Arms (2)
Control
NO INTERVENTIONPatients included in this arm wil have usual follow-up.
Care transitional program
EXPERIMENTALPatients 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
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
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
Hospices Civils de Lyon
Lyon, France
Hôpital Européen Georges Pompidou
Paris, France
Hôpital Necker
Paris, France
Centre Hospitalier de Pontoise
Pontoise, France
Related Publications (1)
Hoegy D, Bleyzac N, Gauthier-Vasserot A, Cannas G, Denis A, Hot A, Bertrand Y, Occelli P, Touzet S, Dussart C, Janoly-Dumenil A; DREPADO study group. Impact of a paediatric-adult care transition programme on the health status of patients with sickle cell disease: study protocol for a randomised controlled trial (the DREPADO trial). Trials. 2020 Feb 10;21(1):152. doi: 10.1186/s13063-019-4009-9.
PMID: 32039737DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2018
First Posted
December 26, 2018
Study Start
January 16, 2019
Primary Completion (Estimated)
April 16, 2027
Study Completion (Estimated)
April 16, 2027
Last Updated
June 21, 2024
Record last verified: 2024-06