Impact of a Pediatric-adult Care Transition Program on the Health Status of Patients With Sickle Cell Disease – A Randomized Controlled Trial

About the study

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 point of contact

Sandrine TOUZET, Dr
04 72 11 57 61 ext +33
[email protected]
Alexandra GAUTHIER VASSEROT, DR
04 69 16 65 72 ext +33
[email protected]

Locations

8 France sites

Age

16 to 17 Years

Phase

N/A

Study type

Interventional

Gender

All

Interventions

Other

Compensation

Unknown

participation requirements

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.

participation restrictions

– 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.

Locations

  • Fort-de-France-La Martinique, La Martinique, France, CHU de Fort de France [Not yet recruiting]
  • Créteil, France, Centre Hospitalier Intercommunal de Creteil [Not yet recruiting]
  • Créteil, France, Hôpital Mondor [Not yet recruiting]
  • Le Kremlin-Bicêtre, France, Hôpital Bicêtre [Not yet recruiting]
  • Lyon, France, Hospices Civils de Lyon [Recruiting]
  • Paris, France, Hôpital Européen Georges Pompidou [Not yet recruiting]
  • Paris, France, Hôpital Necker [Not yet recruiting]
  • Pontoise, France, Centre Hospitalier de Pontoise [Not yet recruiting]
Last updated 2021-08-24