一项研究小组医疗预约对镰状细胞病自我效能和依从性的有效性的随机对照试验（团队研究）：研究方案。
A randomized controlled trial studying the effectiveness of group medical appointments on self-efficacy and adherence in sickle cell disease (TEAM study): study protocol.
作者信息
Madderom Marlous J, Heijdra Jessica, Utens Elisabeth M W J, Polinder Suzanne, Rijneveld Anita W, Cnossen Marjon H
机构信息
Department of Pediatric Hematology, Erasmus University Medical Center - Sophia Children's Hospital, Wytemaweg 80, PO Box 2060, 3000 CB Rotterdam, The Netherlands.
Department of Child and Adolescent Psychiatry/Psychology, Erasmus University Medical Center - Sophia Children's Hospital, Wytemaweg 80, PO Box 2060, 3000 CB Rotterdam, The Netherlands.
出版信息
BMC Hematol. 2016 Aug 4;16:21. doi: 10.1186/s12878-016-0058-4. eCollection 2016.
BACKGROUND
Sickle cell disease (SCD) is endemic in non-Western countries. Due to migration, the prevalence of SCD in the Netherlands has increased. Adherence to medical treatment is recognized as a major problem area. Therefore, new effective interventions to increase adherence are urgently needed.
METHODS/DESIGN: The TEAM study is an ongoing randomized controlled trial (RCT) to compare protocolized individual medical appointments (IMA's; care-as-usual) with protocolized group medical appointments (GMA's; novel intervention) in pediatric (n = 40) and adult (n = 60) patients. The study aims to assess the effectiveness of GMA's (over a three year period) on patients' self-efficacy, adherence, quality of life, morbidity, hospital admissions and satisfaction with the treating professional; as well as to test the cost-effectiveness of GMA's. In both the IMA and GMA groups structured assessments will be performed at baseline (start of the study), after 1.5 and after 3 years.
DISCUSSION
This is the first RCT to investigate the effectiveness of GMA's on self-efficacy and adherence in pediatric and adult patients with SCD, including a cost-effectiveness analysis.
TRIAL REGISTRATION
NTR4750 (NL42182.000.12). Registered 13 August 2014.
背景
镰状细胞病（SCD）在非西方国家呈地方性流行。由于移民，荷兰SCD的患病率有所上升。坚持药物治疗被认为是一个主要问题领域。因此，迫切需要新的有效干预措施来提高依从性。
方法/设计：TEAM研究是一项正在进行的随机对照试验（RCT），旨在比较小儿（n = 40）和成人（n = 60）患者的标准化个体医疗预约（IMA；常规护理）与标准化集体医疗预约（GMA；新型干预措施）。该研究旨在评估GMA（在三年期间）对患者自我效能感、依从性、生活质量、发病率、住院情况以及对治疗专业人员满意度的有效性；同时测试GMA的成本效益。在IMA组和GMA组中，将在基线（研究开始时）、1.5年后和3年后进行结构化评估。
讨论
这是第一项研究GMA对小儿和成人SCD患者自我效能感和依从性有效性的RCT，包括成本效益分析。
试验注册
NTR4750（NL42182.000.12）。于2014年8月13日注册。
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