基于生活方式选择和指导干预的护士主导护理对伴有高动脉粥样硬化性心血管风险的 2 型糖尿病患者收缩压的影响：一项整群随机试验研究方案。

Effect of a nurse-led lifestyle choice and coaching intervention on systolic blood pressure among type 2 diabetic patients with a high atherosclerotic cardiovascular risk: study protocol for a cluster-randomized trial.

机构信息

Department of Internal Medicine, Mengo Hospital, Kampala, Uganda.

Uganda Martyrs Hospital Lubaga, Kampala, Uganda.

出版信息

Trials. 2021 Feb 11;22(1):133. doi: 10.1186/s13063-021-05085-z.

DOI:10.1186/s13063-021-05085-z

PMID:33573687

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7879519/

Abstract

BACKGROUND

More than 50% of patients with type 2 diabetes have hypertension in Uganda. Diabetic patients with elevated systolic blood pressure experience higher all-cause mortality and cardiovascular events compared with normotensive diabetic individuals, hence escalating resource utilization and cost of care. The aim of this study is to determine the effect of a nurse-led lifestyle choice and coaching intervention on systolic blood pressure among type 2 diabetic patients with a high atherosclerotic cardiovascular risk.

METHODS

This is a cluster-randomized study comprising two arms (intervention and non-intervention-control arm) with four clusters per arm with 388 diabetic patients with a high predicted 10-year atherosclerotic cardiovascular risk. The study will be implemented in 8 health facilities in Uganda. The intervention arm will employ a nurse-led lifestyle choice and coaching intervention. Within the intervention, nurses will be trained to provide structured health education, protocol-based hypertension management, and general atherosclerotic cardiovascular risk factor management, 24-h phone calls, and 2-monthly text messaging. The control group will be constituted by the usual care. The primary outcome measure is the mean difference in systolic blood pressure between the intervention and usual care groups after 6 months. The study is designed to have an 80% statistical power to detect an 8.5-mmHg mean reduction in systolic blood pressure from baseline to 6 months. The unit of analysis for the primary outcome is the individual participants. To monitor the effect of within-cluster correlation, generalized estimating equations will be used to assess the changes over time in systolic blood pressure as a continuous variable.

DISCUSSION

The data generated from this trial will inform change in the policy of shifting task of screening of hypertension and atherosclerotic cardiovascular disease from doctors to nurses.

TRIAL REGISTRATION

Pan African Trials Registry PACTR 202001916873358 . Registered on 6 October 2019.

摘要

背景

在乌干达，超过 50%的 2 型糖尿病患者患有高血压。与血压正常的糖尿病患者相比，收缩压升高的糖尿病患者发生全因死亡率和心血管事件的风险更高，因此增加了资源利用和医疗成本。本研究旨在确定护士主导的生活方式选择和指导干预对高动脉粥样硬化性心血管风险 2 型糖尿病患者收缩压的影响。

方法

这是一项包括两个组（干预组和非干预对照组）的集群随机研究，每组有四个集群，共有 388 名高预测 10 年动脉粥样硬化性心血管风险的糖尿病患者。该研究将在乌干达的 8 家卫生机构实施。干预组将采用护士主导的生活方式选择和指导干预。在干预组中，护士将接受培训，提供结构化健康教育、基于方案的高血压管理以及一般动脉粥样硬化性心血管风险因素管理、24 小时电话咨询和 2 个月短信服务。对照组将由常规护理组成。主要结局指标是干预组和常规护理组在 6 个月后收缩压的平均差异。该研究设计有 80%的统计效力，以检测从基线到 6 个月收缩压平均降低 8.5mmHg。主要结局的分析单位是个体参与者。为了监测组内相关性的影响，将使用广义估计方程来评估收缩压作为连续变量随时间的变化。