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Nurse-led Reminder Program for the Prevention of Cardiovascular Diseases

2015年7月20日 更新者:Lamberto Manzoli、Università degli Studi 'G. d'Annunzio' Chieti e Pescara

Efficacy of a Nurse-led Reminder Program for the Management of the Risk Factors for Cardiovascular Diseases in Hypertensive Patients: a Randomized Controlled Trial

A number of strategies have been evaluated to improve the prevention and control of the main cardiovascular (CVD) risk factors. Nursing telephonic and tele-counseling individualized lifestyle educational programs were found to improve blood pressure (BP) control and adherence to healthy lifestyle. This study aims at evaluating for the first time the efficacy of a nurse-led reminder program through email (NRP-e) to improve CVD risk factors among hypertensive adults.

Participants will receive usual care and a guideline-based educational program on BP control and healthy lifestyle habits. Subjects in the NRP-e group will also receive weekly email alerts and phone calls from a nurse care manager for 6 months. Emails contain a reminder program on the compliance with a healthy lifestyle based upon current guidelines for CVD prevention. Follow-up visits will be scheduled at 1, 3 and 6 months after enrollment; randomization will be made centrally and blood samples will be evaluated into a single, accredited laboratory.

研究概览

研究类型

介入性

注册 (实际的)

203

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Abruzzo
      • Chieti、Abruzzo、意大利、66100
        • ASL02Abruzzo
    • CH
      • Chieti、CH、意大利、66100
        • Department of Medicine and Aging Sciences, University of Chieti

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 80年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • to be eligible, all subjects had to be hypertensive (on active treatment for hypertension, or systolic blood pressure ≥ 140 mmHg; or
  • diastolic blood pressure ≥ 90 mmHg).
  • speaking and reading Italian,
  • having a active phone number and an email address, and
  • providing a signed informed consent.

Exclusion Criteria:

  • mental illness;
  • nursing home institutionalization;
  • pregnancy;
  • previous cardiovascular major events, non-modifiable cardiovascular risk-factors (i.e. diabetes).

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
无干预:Usual care
Educational program and usual cardiovascular prevention.
实验性的:Nurse-led reminder through email
In addition to usual care and educational program, the intervention group will also receive email alerts and phone calls from the nurse-care manager (NCM)

Both groups will receive an educational program and usual care. The educational program will consist of 1-hour sessions, during which the NCM emphasize the importance of blood pressure control and correct measurement, give advice for a correct blood pressure self-measurement; report non-pharmacological strategies for a healthy lifestyle, and instruction on how to fill the daily self-assessment form.

Educational program and usual cardiovascular prevention. The educational program will consist of 1-hour sessions, during which the NCM emphasize the importance of blood pressure control and correct measurement, give advice for a correct blood pressure self-measurement; report non-pharmacological strategies for a healthy lifestyle, and instruction on how to fill the daily self-assessment form.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
The main outcome of the study was the mean difference between groups in the average reduction in systolic and diastolic blood pressure between baseline and the end of follow-up
大体时间:6 months
6 months

次要结果测量

结果测量
大体时间
Mean difference between groups in the average reduction in LDL cholesterol between baseline and the end of follow-up
大体时间:6 months
6 months
Mean difference between groups in the average reduction in physical activity between baseline and the end of follow-up
大体时间:6 months
6 months
Mean difference between groups in the average reduction in BMI between baseline and the end of follow-up
大体时间:6 months
6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Giancarlo GC Cicolini, PhD、ASL 02 Abruzzo - Abruzzo Region - Italy

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年4月1日

初级完成 (实际的)

2013年5月1日

研究完成 (实际的)

2013年5月1日

研究注册日期

首次提交

2013年3月28日

首先提交符合 QC 标准的

2013年4月2日

首次发布 (估计)

2013年4月4日

研究记录更新

最后更新发布 (估计)

2015年7月22日

上次提交的符合 QC 标准的更新

2015年7月20日

最后验证

2015年7月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • Nurse led

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