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魔鬼在细节中——一项多因素干预措施,以降低同时存在的糖尿病和慢性肾脏病患者的血压:一项单盲、随机对照试验。

The devil is in the detail - a multifactorial intervention to reduce blood pressure in co-existing diabetes and chronic kidney disease: a single blind, randomized controlled trial.

机构信息

Melbourne School of Health Sciences, The University of Melbourne, Level 5, 234 Queensberry Street, Carlton, Australia 3053.

出版信息

BMC Fam Pract. 2010 Jan 12;11:3. doi: 10.1186/1471-2296-11-3.

DOI:10.1186/1471-2296-11-3
PMID:20064272
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2817677/
Abstract

BACKGROUND

About 30-60% of individuals are non-adherent to their prescribed medications and this risk increases as the number of prescribed medications increases. This paper outlines the development of a consumer-centred Medicine Self-Management Intervention (MESMI), designed to improve blood pressure control and medication adherence in consumers with diabetes and chronic kidney disease recruited from specialist outpatients' clinics.

METHODS

We developed a multifactorial intervention consisting of Self Blood Pressure Monitoring (SBPM), medication review, a twenty-minute interactive Digital Versatile Disc (DVD), and follow-up support telephone calls to help consumers improve their blood pressure control and take their medications as prescribed. The intervention is novel in that it has been developed from analysis of consumer and health professional views, and includes consumer video exemplars in the DVD. The primary outcome measure was a drop of 3-6 mmHg systolic blood pressure at three months after completion of the intervention. Secondary outcome measures included: assessment of medication adherence, medication self-efficacy and general wellbeing. Consumers' adherence to their prescribed medications was measured by manual pill count, self-report of medication adherence, and surrogate biochemical markers of disease control.

DISCUSSION

The management of complex health problems is an increasing component of health care practice, and requires interventions that improve patient outcomes. We describe the preparatory work and baseline data of a single blind, randomized controlled trial involving consumers requiring cross-specialty care with a follow-up period extending to 12 months post-baseline.

TRIAL REGISTRATION

The trial was registered with the Australian and New Zealand Clinical Trials Register (ACTRN12607000044426).

摘要

背景

约 30-60%的个体不遵守其规定的药物治疗方案,且随着规定药物数量的增加,这种风险会增加。本文概述了一种以消费者为中心的药物自我管理干预(MESMI)的制定过程,该干预旨在改善从专科门诊招募的患有糖尿病和慢性肾病的消费者的血压控制和药物依从性。

方法

我们开发了一种多因素干预措施,包括自我血压监测(SBPM)、药物审查、时长为 20 分钟的互动数字多功能光盘(DVD)以及随访支持电话,以帮助消费者改善血压控制并按规定服用药物。该干预措施是新颖的,因为它是根据消费者和卫生专业人员的观点分析而制定的,并且在 DVD 中包含了消费者视频范例。主要结局测量指标是干预完成后三个月收缩压下降 3-6mmHg。次要结局测量指标包括:评估药物依从性、药物自我效能和整体健康状况。消费者的药物依从性通过手动药片计数、药物依从性自我报告以及疾病控制的替代生化标志物来衡量。

讨论

复杂健康问题的管理是医疗保健实践的一个日益重要的组成部分,需要采取能够改善患者结局的干预措施。我们描述了一项单盲、随机对照试验的准备工作和基线数据,该试验涉及需要跨专科护理的消费者,随访期延长至基线后 12 个月。

试验注册

该试验已在澳大利亚和新西兰临床试验注册中心(ACTRN12607000044426)注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/721b/2817677/0ead71aded11/1471-2296-11-3-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/721b/2817677/0ead71aded11/1471-2296-11-3-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/721b/2817677/0ead71aded11/1471-2296-11-3-1.jpg

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