EA 4129 P2S Parcours Santé Systémique-Université Claude Bernard Lyon 1, Université Lyon 1, Lyon, France.
Pharmacie Hôpital Edouard Herriot, Hospices Civils de Lyon, 5 place d'Arsonval, 69003, Lyon, France.
Trials. 2020 Feb 10;21(1):152. doi: 10.1186/s13063-019-4009-9.
Thanks to advancements in medical care, a majority of patients with sickle cell disease (SCD) worldwide live beyond 18 years of age, and therefore, patients initially followed in paediatric departments are then transferred to adult departments. This paediatric-adult care transition is a period with an increased risk of discontinuity of care and subsequent morbidity and mortality. During this period, the patient will have to manage new interlocutors and places of care, and personal issues related to the period of adolescence. To take into consideration all these aspects, an interesting approach is to use the whole system approach to the patient, as presented in the biopsychosocial approach. The aim of this trial is to evaluate the impact of the proposed biopsychosocial paediatric-adult transition programme.
The DREPADO study is a multicentre randomised control trial comparing a control group (Arm A) to an interventional group with a paediatric-adult transition programme based on a biopsychosocial approach (Arm B). To be included, patients should have the SS, SC, or Sβ form of sickle cell disease and be aged between 16 and 17 years. The randomisation in a 1:1 ratio assigns to Arm A or B. The primary outcome is the number of hospital admissions and emergencies for complications in the index hospital, in the 2 years after the first consultation in the adult department of care. Secondary outcomes consider the quality of life, but also include coping skills such as sense of self-efficacy and disease knowledge. To provide patient and parent knowledge and coping skills, the transition programme is composed of three axes: educational, psychological, and social, conducted individually and in groups.
By providing self-care knowledge and coping skills related to SCD and therapeutics, helping empower patientsin relation to pain management and emotions, and facilitating the relationship to oneself, others, and care in Arm B of the DREPADO study, we believe that the morbidity and mortality of patients with SCD may be reduced after the proposed paediatric-adult transition programme.
ClinicalTrials.gov, ID: NCT03786549; registered on 17 December 2018; https://clinicaltrials.gov/.
由于医疗保健的进步，全球大多数镰状细胞病（SCD）患者的寿命超过 18 岁，因此最初在儿科部门接受治疗的患者随后被转至成人部门。这种儿科到成人的护理过渡时期存在着护理连续性中断以及随后发病率和死亡率增加的风险。在此期间，患者将不得不管理新的对话者和护理场所，并处理与青春期相关的个人问题。为了考虑到所有这些方面，一种有趣的方法是使用整体系统方法来对待患者，如生物心理社会方法所示。本试验的目的是评估所提出的生物心理社会儿科到成人过渡方案的影响。
DREPADO 研究是一项多中心随机对照试验，比较对照组（A 组）和基于生物心理社会方法的儿科到成人过渡方案的干预组（B 组）。纳入标准为患者应患有 SS、SC 或 Sβ 型镰状细胞病，年龄在 16 至 17 岁之间。1:1 比例随机分配至 A 组或 B 组。主要结局是首次在成人护理部门就诊后 2 年内索引医院因并发症而住院和急诊的次数。次要结局考虑生活质量，但也包括应对技能，如自我效能感和疾病知识。为了提供患者和家长的知识和应对技能，过渡方案由教育、心理和社会三个轴组成，单独和小组进行。
通过提供与 SCD 和治疗相关的自我护理知识和应对技能，帮助患者增强对疼痛管理和情绪的掌控感，并促进患者与自己、他人和护理的关系，我们相信 DREPADO 研究 B 组的镰状细胞病患者的发病率和死亡率可能会降低。
ClinicalTrials.gov，ID：NCT03786549；注册于 2018 年 12 月 17 日；https://clinicaltrials.gov/。
