一项针对糖尿病患者的社区基层同伴主导项目的整群随机对照试验的心血管风险结果与项目评估
Cardiovascular risk outcome and program evaluation of a cluster randomised controlled trial of a community-based, lay peer led program for people with diabetes.
作者信息
Riddell M A, Dunbar J A, Absetz P, Wolfe R, Li H, Brand M, Aziz Z, Oldenburg B
机构信息
Department of Epidemiology and Preventive Medicine, Faculty of Medicine Nursing and Health Science, Monash University, The Alfred Centre, 99 Commercial Road, Melbourne, Victoria, 3004, Australia.
Deakin Population Health Strategic Research Centre, Deakin University, Melbourne, Australia.
出版信息
BMC Public Health. 2016 Aug 24;16(1):864. doi: 10.1186/s12889-016-3538-3.
BACKGROUND
The 2013 Global Burden of Disease Study demonstrated the increasing burden of diabetes and the challenge it poses to the health systems of all countries. The chronic and complex nature of diabetes requires active self-management by patients in addition to clinical management in order to achieve optimal glycaemic control and appropriate use of available clinical services. This study is an evaluation of a "real world" peer support program aimed at improving the control and management of type 2 diabetes (T2DM) in Australia.
METHODS
The trial used a randomised cluster design with a peer support intervention and routine care control arms and 12-month follow up. Participants in both arms received a standardised session of self-management education at baseline. The intervention program comprised monthly community-based group meetings over 12 months led by trained peer supporters and active encouragement to use primary health care and other community resources and supports related to diabetes. Clinical, behavioural and other measures were collected at baseline, 6 and 12 months. The primary outcome was the predicted 5 year cardiovascular disease risk using the United Kingdom Prospective Diabetes Study (UKPDS) Risk Equation at 12 months. Secondary outcomes included clinical measures, quality of life, measures of support, psychosocial functioning and lifestyle measures.
RESULTS
Eleven of 12 planned groups were successfully implemented in the intervention arm. Both the usual care and the intervention arms demonstrated a small reduction in 5 year UKPDS risk and the mean values for biochemical and anthropometric outcomes were close to target at 12 months. There were some small positive changes in self-management behaviours.
CONCLUSIONS
The positive changes in self-management behaviours among intervention participants were not sufficient to reduce cardiovascular risk, possibly because approximately half of the study participants already had quite well controlled T2DM at baseline. Future research needs to address how to enhance community based programs so that they reach and benefit those most in need of resources and supports to improve metabolic control and associated clinical outcomes.
TRIAL REGISTRATION
Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12609000469213 . Registered 16 June 2009.
背景
2013年全球疾病负担研究表明，糖尿病负担日益加重，给各国卫生系统带来挑战。糖尿病的慢性和复杂性要求患者在临床管理之外积极进行自我管理，以实现最佳血糖控制并合理利用现有临床服务。本研究旨在评估一项旨在改善澳大利亚2型糖尿病（T2DM）控制与管理的“真实世界”同伴支持项目。
方法
该试验采用随机整群设计，设有同伴支持干预组和常规护理对照组，并进行为期12个月的随访。两组参与者在基线时均接受了标准化的自我管理教育课程。干预项目包括在12个月内由经过培训的同伴支持者每月组织一次社区小组会议，并积极鼓励参与者利用初级卫生保健及其他与糖尿病相关的社区资源和支持。在基线、6个月和12个月时收集临床、行为及其他指标。主要结局是在12个月时使用英国前瞻性糖尿病研究（UKPDS）风险方程预测的5年心血管疾病风险。次要结局包括临床指标、生活质量、支持措施、心理社会功能及生活方式指标。
结果
干预组成功实施了计划中的12个小组中的11个。常规护理组和干预组的5年UKPDS风险均略有降低，且生化和人体测量指标的平均值在12个月时接近目标值。自我管理行为有一些小的积极变化。
结论
干预参与者自我管理行为的积极变化不足以降低心血管风险，可能是因为约一半的研究参与者在基线时T2DM控制情况就相当良好。未来研究需要探讨如何加强基于社区的项目，使其能够惠及最需要资源和支持以改善代谢控制及相关临床结局的人群。
试验注册
澳大利亚新西兰临床试验注册中心（ANZCTR）ACTRN12609000469213。2009年6月16日注册。
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