NCT03786549: DREPADO

Pediatric -Adult Care Transition Program of Patients With Sickle Cell Disease

Recruiting now NA Last updated 21 June 2024

What this trial tests

NA trial testing pediatric-adult care transition program in Sickle Cell Disease in 196 participants. Currently enrolling.

Timeline

16 January 2019

Primary endpoint
16 April 2027

16 April 2027

Quick facts

Lead sponsor	Hospices Civils de Lyon
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	196
Start date	16 January 2019
Primary completion	16 April 2027
Estimated completion	16 April 2027
Sites	8 locations across France

Drugs / interventions tested

• pediatric-adult care transition program

Conditions studied

• Sickle Cell Disease — all drugs for Sickle Cell Disease →

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

Adults 16 to 17, any sex, with Sickle Cell Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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).
   Hoegy D, Bleyzac N, Gauthier-Vasserot A, Cannas G, et al · · 2020 · cited 6× · PMID 32039737 · DOI 10.1186/s13063-019-4009-9
2. Impact of COVID-19 pandemic on access to online therapeutic education programs for children with sickle cell disease.
   Sterlin A, de Montalembert M, Taylor M, Mensah S, et al · · 2022 · PMID 35816905 · DOI 10.1016/j.pedn.2022.06.014
3. 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)
   Hoegy D, Bleyzac N, Gauthier-Vasserot A, Cannas G, et al · · 2019 · DOI 10.21203/rs.2.16608/v1