Computer-Aided Prevention System

Study Overview
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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.

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

Conditions
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Stroke, Cerebrovascular Diseases, Cardiovascular Diseases, CVD Risk Factors

Intervention / Treatment
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* Behavioral: Standard care
* Behavioral: CAPSYS


Participation Criteria
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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 Exclusion Criteria: Inability to fill out or to understand the informed consent No signed informed consent Dementia

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard care (SC)<br> | Behavioral: Standard care<br>* 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.<br>|
| Experimental: Interventional care (IC)<br> | Behavioral: CAPSYS<br>* In addition to the usual care, patients are asked to call the CAPSYS system twice a week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Systolic Blood Pressure |  | baseline and 6 months | 
| Change in HDL Level |  | baseline and 6 months | 
| Change in LDL Level |  | baseline and 6 months | 
| Change in Triglyceride Level |  | baseline and 6 months | 
| Change in HbA1c Level |  | baseline and 6 months | 
| Change in Glycaemia Level |  | baseline and 6 months | 
| Change in BMI Value |  | baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fruits and Vegetables Consumption | Self-reported weekly portions of fruits and vegetables consumption (During the recruiting interview, participants were instructed in estimating the size of a portion of fruits or vegetables and they were provided an information booklet on this topic.) | baseline and 6 months | 
| Change in Whole Grain Food Consumption | Self-reported weekly portions of whole grain food consumption (During the recruiting interview, participants were instructed in estimating the size of a portion of whole grain food and they were provided an information booklet on this topic.) | baseline and 6 months | 
| Change in Sweets Consumption | Self-reported weekly portions of sweets consumption (During the recruiting interview, participants were instructed in estimating the size of a portion of sweets and they were provided an information booklet on this topic.) | baseline and 6 months | 
| Change in Duration of Physical Activity | Self-reported weekly duration of physical activity of medium or high intensity | baseline and 6 months | 
| Change in Quality of Life | The QoL was measured using the standardised EQ-5D-5L instrument provided by the EuroQol Group. In this context, the health value was specified by the participants on a subjective scale ranging from 0 (The worst health you can imagine) to 100 (The best health you can imagine). | baseline and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lifestyle coaching, Phone-based system, CVD prevention, Patient-centered decision support