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

Sickle Cell Disease Clinical Trial

— DREPADO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03786549
• Other study ID #: 69HCL18_0039
• Secondary ID: 2018-A02198-47
• Status: Recruiting
• Phase: N/A
• Start date: January 16, 2019
• Est. completion date: April 16, 2027

Study information

• Verified date: April 2022
• Source: Hospices Civils de Lyon
• Contact: Alexandra GAUTHIER VASSEROT, DR
• Phone: 04 69 16 65 72
• Email: alexandra.gauthier[@]ihope.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 196
• Est. completion date: April 16, 2027
• Est. primary completion date: April 16, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 17 Years

Eligibility

Inclusion Criteria:

For patients :

• Age: 16-17 years,
• With major sickle cell syndrome, defined by hemoglobinopathy of homozygosity SS, or double heterozygosity SC or Sß-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.

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

Other:
• pediatric-adult care transition 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

Locations

Country	Name	City	State
France	Centre Hospitalier Intercommunal de Creteil	Créteil
France	Hôpital Mondor	Créteil
France	CHU de Fort de France	Fort-de-France-La Martinique	La Martinique
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

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

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