针对出院后发生急性冠脉事件的 2 型糖尿病患者的个体化支持 - 一项随机对照试验的设计和开发。
Tailored support for type 2 diabetes patients with an acute coronary event after discharge from hospital - design and development of a randomised controlled trial.
机构信息
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, STR 6,131, P,O, box 85500, Utrecht, GA 3508, The Netherlands.
出版信息
Diabetol Metab Syndr. 2014 Jan 18;6(1):5. doi: 10.1186/1758-5996-6-5.
BACKGROUND
Type 2 diabetes mellitus patients with an acute coronary event (ACE) experience decreased quality of life and increased distress. According to the American Diabetes Association, discharge from the hospital is a time of increased distress for all patients. Tailored support specific to diabetes is scarce in that period. We developed an intervention based on Bandura's Social Cognitive Theory, Leventhal's Common Sense Model, and results of focus groups. The aim of this study is to evaluate the effectiveness of the intervention to reduce distress in type 2 diabetes patients who experienced a first ACE.
METHODS
Randomised controlled trial. Two hundred patients are recruited in thirteen hospitals. A diabetes nurse visits the patients in the intervention group (n = 100) at home within three weeks after discharge from hospital, and again after two weeks and two months. The control group (n = 100) receives a consultation by telephone. The primary outcome is diabetes-related distress, measured with the Problem Areas in Diabetes (PAID) questionnaire. Secondary outcomes are well-being, health status, anxiety, depression, HbA1c, blood pressure and lipids. Mediating variables are self-management, self-efficacy and illness representations. Outcomes are measured with questionnaires directly after discharge from hospital and five months later. Biomedical variables are obtained from the records from the primary care physician and the hospital. Differences between groups in change over time are analysed according to the intention-to-treat principle. The Holm-Bonferroni correction is used to adjust for multiplicity.
DISCUSSION
Type 2 diabetes patients who experience a first ACE need tailored support after discharge from the hospital. This trial will provide evidence on the effectiveness of a supportive intervention in reducing distress in these patients.
TRIAL REGISTRATION
NCT01801631.
背景
患有急性冠脉事件 (ACE) 的 2 型糖尿病患者生活质量下降，痛苦增加。根据美国糖尿病协会的说法，所有患者在出院时都会感到更加痛苦。在那段时间里，针对糖尿病的特定支持非常稀缺。我们根据班杜拉的社会认知理论、莱文瑟尔的常识模型以及焦点小组的结果开发了一种干预措施。本研究的目的是评估该干预措施对首次 ACE 后 2 型糖尿病患者减轻痛苦的有效性。
方法
随机对照试验。在 13 家医院招募了 200 名患者。出院后 3 周内，糖尿病护士会上门家访干预组（n=100）患者，然后在 2 周和 2 个月后再次家访。对照组（n=100）接受电话咨询。主要结局是用糖尿病相关痛苦量表（PAID）评估糖尿病相关痛苦。次要结局是幸福感、健康状况、焦虑、抑郁、HbA1c、血压和血脂。中介变量是自我管理、自我效能和疾病认知。直接在出院时和 5 个月后测量结果。通过初级保健医生和医院的记录获得生物医学变量。根据意向治疗原则分析组间随时间的变化差异。采用 Holm-Bonferroni 校正法进行多重性调整。
讨论
首次经历 ACE 的 2 型糖尿病患者出院后需要有针对性的支持。该试验将提供关于支持性干预措施在减轻这些患者痛苦方面有效性的证据。
试验注册
NCT01801631。
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