Computer-Aided Prevention System

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cerebrovascular Diseases Stroke Cardiovascular Diseases CVD Risk Factors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Standard care (SC)

Group Type ACTIVE_COMPARATOR

Standard care

Intervention Type BEHAVIORAL

Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.

Interventional care (IC)

Group Type EXPERIMENTAL

CAPSYS

Intervention Type BEHAVIORAL

In addition to the usual care, patients are asked to call the CAPSYS system twice a week.

Interventions

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Standard care

Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.

Intervention Type BEHAVIORAL

CAPSYS

In addition to the usual care, patients are asked to call the CAPSYS system twice a week.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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
* Smoking
* Unhealthy diet