Computer-Aided Prevention System "CAPSYS"

Completed

Phase N/A Results

Trial Description

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.

Conditions

Interventions

  • Standard Care Behavioral
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Standard care (SC)
  • CAPSYS Behavioral
    Intervention Desc: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
    ARM 1: Kind: Experimental
    Label: Interventional care (IC)
    Description: Patients are asked to call the CAPSYS system twice a week.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Prevention
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change in systolic blood pressure baseline and 6 months No
Primary Change in HDL level baseline and 6 months No
Primary Change in LDL level baseline and 6 months No
Primary Change in triglyceride level baseline and 6 months No
Primary Change in HbA1c level baseline and 6 months No
Primary Change in glycaemia level baseline and 6 months No
Primary Change in BMI value baseline and 6 months No
Secondary Change in fruits and vegetables consumption baseline and 6 months No
Secondary Change in whole grain food consumption baseline and 6 months No
Secondary Change in sweets consumption baseline and 6 months No
Secondary Change in duration of physical activity baseline and 6 months No
Secondary Change in Quality of Life baseline and 6 months No

Sponsors