Computer-Aided Prevention System

Not Applicable

Completed

• Conditions: Stroke; Cerebrovascular Diseases; CVD Risk Factors; Cardiovascular Diseases
• Interventions: Behavioral: CAPSYS; Behavioral: Standard care

• Registration Number: NCT02444715
• Lead Sponsor: Lübomira Spassova

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Study First Submitted: 2015-05-12
• Study First Submitted QC: 2015-05-13
• Study First Posted: 2015-05-14
• Results First Submitted: 2015-06-08
• Results First Submitted QC: 2015-07-27
• Results First Posted: 2015-08-24
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-20
• Last Update Posted: 2016-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional care (IC)	CAPSYS	-
Standard care (SC)	Standard care	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change in Fruits and Vegetables Consumption	baseline and 6 months	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.)
Change in Whole Grain Food Consumption	baseline and 6 months	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.)
Change in Sweets Consumption	baseline and 6 months	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.)
Change in Duration of Physical Activity	baseline and 6 months	Self-reported weekly duration of physical activity of medium or high intensity
Change in Quality of Life	baseline and 6 months	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").