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

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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

Первичные конечные точки

• Incidence of sickle cell related severe complications leading to hospitalization [Срок оценки: Within 24 months after transfer to the adult sector]

Вторичные конечные точки (12)

• Frequency of emergency visits in the index hospital [Срок оценки: Up to 2 years]
• Frequency of emergency visits in the index hospital [Срок оценки: Within 12 months after transfer to the adult sector]
• Frequency of emergency visits in the index hospital [Срок оценки: Within 12 and 24 months after transfer to the adult sector]
• Medication Intake Survey-Asthma (MIS-A) questionnaire score [Срок оценки: At inclusion]
• Medication Rating Scale (MARS) questionnaire score [Срок оценки: At inclusion]
• MIS-A questionnaire score [Срок оценки: Up to 2 years]
• MARS questionnaire score [Срок оценки: Up to 2 years]
• MIS-A questionnaire score [Срок оценки: within 12 months after transfer to the adult sector]
• MARS questionnaire score [Срок оценки: within 12 months after transfer to the adult sector]
• MIS-A questionnaire score [Срок оценки: within 24 months after transfer to the adult sector]
• MARS questionnaire score [Срок оценки: within 24 months after transfer to the adult sector]
• Number of days absent at school [Срок оценки: Up to 2 years]

Критерии участия

Критерии включения

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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Франция · 8 центров

• CHU de Fort de France — Fort-de-France-La Martinique
• Centre Hospitalier Intercommunal de Creteil — Créteil
• Hôpital Mondor — Créteil
• Hôpital Bicêtre — Le Kremlin-Bicêtre
• Hospices Civils de Lyon — Lyon
• Hôpital Européen Georges Pompidou — Paris
• Hôpital Necker — Paris
• Centre Hospitalier de Pontoise — Pontoise

Публикации

• 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 32039737

Идентификаторы

NCT: NCT03786549 · 69HCL18_0039 · 2018-A02198-47

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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