一项研究团体医疗预约对镰状细胞病患者自我效能感和依从性有效性的随机对照试验(TEAM研究):研究方案。

Q2 Medicine BMC Hematology Pub Date : 2016-08-04 eCollection Date: 2016-01-01 DOI:10.1186/s12878-016-0058-4
Marlous J Madderom, Jessica Heijdra, Elisabeth M W J Utens, Suzanne Polinder, Anita W Rijneveld, Marjon H Cnossen
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引用次数: 3

摘要

背景:镰状细胞病(SCD)在非西方国家流行。由于移民,荷兰的SCD患病率有所增加。坚持接受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增加依从性。方法/设计:TEAM研究是一项正在进行的随机对照试验(RCT),旨在比较协议化的个人医疗预约(IMA’s;照旧护理),并安排了小组医疗预约(GMA’s;儿童(n = 40)和成人(n = 60)患者的新型干预。本研究旨在评估GMA在患者自我效能、依从性、生活质量、发病率、住院率和对治疗专业人员满意度方面的有效性(超过三年);以及测试GMA的成本效益。IMA组和GMA组将在基线(研究开始)、1.5年后和3年后进行结构化评估。讨论:这是第一个研究GMA对儿童和成人SCD患者自我效能和依从性有效性的随机对照试验,包括成本-效果分析。试验注册:NTR4750 (NL42182.000.12)。注册于2014年8月13日。
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A randomized controlled trial studying the effectiveness of group medical appointments on self-efficacy and adherence in sickle cell disease (TEAM study): study protocol.

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.

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来源期刊
BMC Hematology
BMC Hematology Medicine-Hematology
CiteScore
4.10
自引率
0.00%
发文量
0
期刊介绍: BMC Hematology is an open access, peer-reviewed journal that considers articles on basic, experimental and clinical research related to hematology. The journal welcomes submissions on non-malignant and malignant hematological diseases, hemostasis and thrombosis, hematopoiesis, stem cells and transplantation.
期刊最新文献
Correction to: Rapid and reliable detection of α-globin copy number variations by quantitative real-time PCR Correction to: Patterns of bone marrow aspiration confirmed hematological malignancies in Eritrean National Health Laboratory. Correction to: The impact of helicobacter pylori eradication on platelet counts of adult patients with idiopathic thrombocytopenic purpura. Assessment of knowledge, attitude and practice and associated factors of blood donation among health care workers in Ethiopia: a cross-sectional study. Health-related quality of life of adolescents with sickle cell disease in sub-Saharan Africa: a cross-sectional study.
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