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临床试验/NCT02444715
NCT02444715已完成不适用

Study on Improved Prevention Methods for Cerebro-cardiovascular Diseases Based on a Computer-aided Prevention System

Lübomira Spassova0 个研究点目标入组 94 人开始时间: 2013年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
94
主要终点
Change in Systolic Blood Pressure

研究概览

简要总结

Stroke is one of the most frequent and life-threatening diseases in Europe. About four stroke events occur per day in Luxembourg alone, and about 30% of these patients are affected by recurrent stroke within the following five years. Thus, new methods of primary and secondary prevention are needed to better control lifestyle-related risk factors.

The development and maintenance of a healthy lifestyle (smoking cessation, healthy nutrition, moderate physical exercises etc.) is a major objective concerning the primary and secondary prevention of cerebro- and cardiovascular diseases. CAPSYS is a computer-based lifestyle coaching system developed by researchers from the Public Research Centre (CRP) Henri Tudor in Luxembourg in collaboration with neurologists from the Centre Hospitalier de Luxembourg (CHL), which aims at supporting patients in performing appropriate behavior changes in order to minimize their individual risk factors. Patients can access CAPSYS by dialing a local-rate telephone number and answer to a set of previously known questions concerning their current nutrition, physical activity, blood pressure, smoking etc. In an interactive voice response approach, questions are issued by the system in natural language using text-to-speech, and the patient can provide the required values using the phone keypad. Based on the gathered values for each patient, the system automatically generates personalized verbal feedback at runtime and presents it to the patient during the phone dialog. Depending on the individual development of the patient's risk factors, the system feedback can contain advice for improvement, praise for healthy behavior and motivation to pursue a certain goal.

The user acceptance and effectiveness of the CAPSYS system is evaluated in a six-month randomized controlled study with participants recruited at CHL's neurology department.

研究设计

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

入排标准

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

入选标准

  • At high risk of stroke:
  • Already suffered a stroke or Transient Ischemic Attack (TIA) or
  • At least two risk factors for stroke:
  • High blood pressure
  • Overweight
  • Low physical activity
  • Unhealthy diet

排除标准

  • Inability to fill out or to understand the informed consent
  • No signed informed consent

结局指标

主要结局

Change in Systolic Blood Pressure

时间窗: baseline and 6 months

Change in HDL Level

时间窗: baseline and 6 months

Change in LDL Level

时间窗: baseline and 6 months

Change in Triglyceride Level

时间窗: baseline and 6 months

Change in HbA1c Level

时间窗: baseline and 6 months

Change in Glycaemia Level

时间窗: baseline and 6 months

Change in BMI Value

时间窗: baseline and 6 months

次要结局

  • Change in Sweets Consumption(baseline and 6 months)
  • Change in Whole Grain Food Consumption(baseline and 6 months)
  • Change in Duration of Physical Activity(baseline and 6 months)
  • Change in Fruits and Vegetables Consumption(baseline and 6 months)
  • Change in Quality of Life(baseline and 6 months)

研究者

发起方
Lübomira Spassova
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lübomira Spassova

Dr.-Ing.

Luxembourg Institute of Science and Technology

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