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临床试验/NCT03524456
NCT03524456已完成不适用

Home Blood Pressure Telemonitoring With an Adapted Device With SMS Capability in the Primary Care Setting

Universidad Peruana Cayetano Heredia1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年4月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Comparison of blood pressure diference before and after the intervention period between the control and intervention arm

研究概览

简要总结

Hypertension is a public health problem worldwide, being responsible for 9.4 million deaths worldwide each year, as well as contributing to the burden of coronary, cerebrovascular, renal diseases, among others. The monitoring of blood pressure at home has gained importance in recent years, being related to adherence to treatment, as well as in the prevention of complications and optimization of pressure levels; In the same way, the use of information and communication technologies (ICT) in health has contributed to the improvement of communication systems by providing alternative tele-monitoring in this type of diseases.

Objective:

To evaluate the impact of tele-monitoring at home through tensiometers with integrated SMS system (text message), for the sending and recording of blood pressure and heart rate data in the primary care setting.

Methods:

A randomized controlled trial will be conducted, evaluating the intervention with the integrated blood pressure device with SMS capability, comparing it with the standard care. After a follow-up of 1 month, the effect on the values of systolic and diastolic blood pressure will be evaluated, as well as the adherence to treatment and complications related to arterial hypertension. A sample number of 20 participants per group was calculated, with a significance of 95% and a power of 80%, to detect a minimum significant difference of 10 mmHg.

详细描述

Objectives

Main Objective:

To evaluate the impact of the home blood pressure telemonitoring through a device with integrated SMS system, in blood pressure values in uncontrolled hypertensive patients.

Secondary objectives:

  1. Compare adherence to treatment at the beginning and end of the follow-up between the group that uses integrated tele-monitoring with SMS and the usual monitoring.
  2. Describe the experiences of the participants of the intervention group with the tele-monitoring system.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Older than 18 years-old.
  • Diagnosis of hypertension more than 3 months ago.
  • Not Controlled hypertension
  • In antihypertensive medication

排除标准

  • Patient with chronic kidney disease on hemodialysis or peritoneal dialysis.
  • Pregnant women.
  • Travel or change of address in the next 4 weeks

研究组 & 干预措施

Usual monitoring

No Intervention

Home blood pressure monitoring

Experimental

干预措施: Home blood pressure monitoring (Other)

结局指标

主要结局

Comparison of blood pressure diference before and after the intervention period between the control and intervention arm

时间窗: 1 month

Changes in the blood pressure levels would be compare in both study groups

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Renzo Calderon

Researcher

Universidad Peruana Cayetano Heredia

研究点 (1)

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