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

April 14, 2022 updated by: Hospices Civils de Lyon

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

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 Overview

Status

Recruiting

Conditions

Study Type

Interventional

Enrollment (Anticipated)

196

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Créteil, France
        • Not yet recruiting
        • Centre Hospitalier Intercommunal de Créteil
        • Contact:
          • Corinne Pondarre
        • Principal Investigator:
          • Corinne Pondarré
      • Créteil, France
        • Not yet recruiting
        • Hôpital Mondor
        • Contact:
          • Frédéric Galactéros
        • Principal Investigator:
          • Frédéric Galactéros
      • Le Kremlin-Bicêtre, France
        • Not yet recruiting
        • Hôpital BICETRE
        • Contact:
          • Corinne Guitton
        • Principal Investigator:
          • Corinne Guitton
        • Principal Investigator:
          • Christelle Chantalat
      • Lyon, France
        • Recruiting
        • Hospices Civils de Lyon
        • Principal Investigator:
          • Giovanna Cannas
        • Contact:
          • Alexandra Gauthier- Vasserot
        • Contact:
          • Giovanna Cannas
        • Principal Investigator:
          • Alexandra Gauthier- Vasserot
      • Paris, France
        • Not yet recruiting
        • Hopital Europeen Georges Pompidou
        • Contact:
          • Jean- Benoît Arlet
        • Principal Investigator:
          • Jean- Benoît Arlet
      • Paris, France
        • Not yet recruiting
        • Hôpital Necker
        • Contact:
          • Marianne de Montalembert
        • Principal Investigator:
          • Marianne De Montalembert
      • Pontoise, France
        • Not yet recruiting
        • Centre Hospitalier de Pontoise
        • Contact:
          • Stéphanie Eyssette- Guerreau
        • Principal Investigator:
          • Stéphanie Eyssette- Guerreau
        • Principal Investigator:
          • Laurent Blum
    • La Martinique
      • Fort-de-France-La Martinique, La Martinique, France
        • Not yet recruiting
        • CHU de Fort de France
        • Contact:
          • Gisèle ELANA, MD
        • Principal Investigator:
          • Gisèle ELANA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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.

Exclusion Criteria:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Patients included in this arm wil have usual follow-up.
Experimental: Care transitional 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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of sickle cell related severe complications leading to hospitalization
Time Frame: Within 24 months after transfer to the adult sector
Number of hospital admission or emergency visit in the index hospital
Within 24 months after transfer to the adult sector

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of emergency visits in the index hospital
Time Frame: Up to 2 years
Frequency of emergency visits in the index hospital Within inclusion and transfer to the adult sector
Up to 2 years
Frequency of emergency visits in the index hospital
Time Frame: Within 12 months after transfer to the adult sector
Within 12 months after transfer to the adult sector
Frequency of emergency visits in the index hospital
Time Frame: Within 12 and 24 months after transfer to the adult sector
Within 12 and 24 months after transfer to the adult sector
Medication Intake Survey-Asthma (MIS-A) questionnaire score
Time Frame: At inclusion
Medication adherence evaluation at inclusion
At inclusion
Medication Rating Scale (MARS) questionnaire score
Time Frame: At inclusion
Medication adherence evaluation at inclusion
At inclusion
MIS-A questionnaire score
Time Frame: Up to 2 years
Medication adherence evaluation At transfer to the adult sector
Up to 2 years
MARS questionnaire score
Time Frame: Up to 2 years
Medication adherence evaluation At transfer to the adult sector
Up to 2 years
MIS-A questionnaire score
Time Frame: within 12 months after transfer to the adult sector
Medication adherence evaluation within 12 months after transfer to the adult sector
within 12 months after transfer to the adult sector
MARS questionnaire score
Time Frame: within 12 months after transfer to the adult sector
This score will allow medication adherence evaluation within 12 months after transfer to the adult sector
within 12 months after transfer to the adult sector
MIS-A questionnaire score
Time Frame: within 24 months after transfer to the adult sector
Medication adherence evaluation within 24 months after transfer to the adult sector
within 24 months after transfer to the adult sector
MARS questionnaire score
Time Frame: within 24 months after transfer to the adult sector
Medication adherence evaluation within 24 months after transfer to the adult sector
within 24 months after transfer to the adult sector
Number of days absent at school
Time Frame: Up to 2 years
Scholarly Absenteeism evaluation At transfer to the adult sector
Up to 2 years
Number of days absent at school
Time Frame: within 12 months after transfer to the adult sector
Scholarly Absenteeism evaluation within 12 months after transfer to the adult sector
within 12 months after transfer to the adult sector
Number of days absent at school
Time Frame: within 24 months after transfer to the adult sector
Scholarly Absenteeism evaluation within 24 months after transfer to the adult sector
within 24 months after transfer to the adult sector
World Health Organization Quality of Life (WHOQOL) questionnaire score
Time Frame: At inclusion
Quality of Life evaluation At inclusion
At inclusion
WHOQOL questionnaire score
Time Frame: Up to 2 years
Quality of Life evaluation At transfer to the adult sector
Up to 2 years
WHOQOL questionnaire score
Time Frame: within 24 months after transfer to the adult sector
Quality of Life evaluation within 24 months after transfer to the adult sector
within 24 months after transfer to the adult sector
EUropean Health Literacy questionnaire (HLS-EU-Q16) score
Time Frame: At inclusion
This will allow Health Literacy evaluation
At inclusion
HLS-EU-Q16 score
Time Frame: Up to 2 years
Health Literacy evaluation At transfer to the adult sector
Up to 2 years
HLS-EU-Q16 score
Time Frame: within 24 months after transfer to the adult sector
Health Literacy evaluation within 24 months after transfer to the adult sector
within 24 months after transfer to the adult sector
Disease knowledge
Time Frame: At inclusion
Questionnaire developed for this study
At inclusion
Disease knowledge
Time Frame: Up to 2 years
Questionnaire developed for this study
Up to 2 years
Disease knowledge
Time Frame: within 24 months after transfer to the adult sector
Questionnaire developed for this study
within 24 months after transfer to the adult sector
Patient activation measure-13 items questionnaire score
Time Frame: At inclusion
Patient activation At inclusion
At inclusion
Patient activation measure-13 items questionnaire score
Time Frame: Up to 2 years
Patient activation At transfer to the adult sector
Up to 2 years
Patient activation measure-13 items questionnaire score
Time Frame: within 24 months after transfer to the adult sector
Patient activation within 24 months after transfer to the adult sector
within 24 months after transfer to the adult sector
Self efficacy specific instrument - sickle cell disease (SCD-SES) questionnaire score
Time Frame: At inclusion
Self efficacy evaluation at inclusion
At inclusion
SCD-SES questionnaire score
Time Frame: Up to 2 years
Self efficacy evaluation At transfer to the adult sector
Up to 2 years
SCD-SES questionnaire score
Time Frame: within 24 months after transfer to the adult sector
Self efficacy evaluation within 24 months after transfer to the adult sector
within 24 months after transfer to the adult sector
Transition readiness assessment questionnaire (TRAQ) questionnaire score
Time Frame: At inclusion
Transition readiness evaluation at inclusion
At inclusion
TRAQ questionnaire score
Time Frame: Up to 2 years
Transition readiness evaluation At transfer to the adult sector
Up to 2 years
TRAQ questionnaire score
Time Frame: within 24 months after transfer to the adult sector
Transition readiness evaluation within 24 months after transfer to the adult sector
within 24 months after transfer to the adult sector
cost effectiveness ratio
Time Frame: Up to 4 years
Cost analysis at the end of the study
Up to 4 years
number of pediatric-adult transition program sessions performed
Time Frame: Up to 4 years
number of interventions performed per patient and date of implementation At the end of the study
Up to 4 years
type of pediatric-adult transition program sessions performed
Time Frame: Up to 4 years
type of interventions performed per patient and date of implementation At the end of the study
Up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2019

Primary Completion (Anticipated)

April 16, 2027

Study Completion (Anticipated)

April 16, 2027

Study Registration Dates

First Submitted

December 13, 2018

First Submitted That Met QC Criteria

December 20, 2018

First Posted (Actual)

December 26, 2018

Study Record Updates

Last Update Posted (Actual)

April 15, 2022

Last Update Submitted That Met QC Criteria

April 14, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 69HCL18_0039
  • 2018-A02198-47 (Other Identifier: ID RCB Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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