Computer-Aided Prevention System (CAPSYS)

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Stroke; Cerebrovascular Diseases; CVD Risk Factors
• Intervention / Treatment: Behavioral: Standard care; Behavioral: CAPSYS

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability: SUS Score	The usability of the intervention was assessed based on the standardised System Usability Scale (SUS). SUS scores were not collected in the SC group because the SC participants were not using CAPSYS and hence were not able to assess its usability. The System Usability Scale (SUS) provides a "quick and dirty", reliable tool for measuring the usability. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. Originally created by John Brooke in 1986, it allows to evaluate a wide variety of products and services, including hardware, software, mobile devices, websites and applications. The total SUS score computed based on the responses provided to each of the 10 items can range from 0 (worst) to 100 (best). Based on research, a SUS score above a 68 would be considered above average and anything below 68 is below average.	6 months

Collaborators and Investigators

• Sponsor: Lübomira Spassova
• Collaborators: Centre Hospitalier du Luxembourg
• Investigators: Study Chair: Lübomira Spassova, Dr.-Ing., Luxembourg Institute of Science and Technology; Study Chair: Debora Vittore, Centre Hospitalier de Luxembourg (CHL); Principal Investigator: Dirk W Droste, Prof. Dr., Centre Hospitalier de Luxembourg (CHL); Study Director: Norbert Rösch, Prof. Dr., University of Applied Sciences Kaiserslautern

Publications and helpful links

General Publications

• Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
• Spassova L, Vittore D, Droste D, Rosch N. Automated lifestyle coaching for cerebro-cardiovascular disease prevention. Stud Health Technol Inform. 2013;190:234-6.
• Spassova L, Vittore D, Droste DW, Rosch N. Randomised controlled trial to evaluate the efficacy and usability of a computerised phone-based lifestyle coaching system for primary and secondary prevention of stroke. BMC Neurol. 2016 Feb 9;16:22. doi: 10.1186/s12883-016-0540-4.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: May 12, 2015
• First Submitted That Met QC Criteria: May 13, 2015
• First Posted (Estimate): May 14, 2015

Study Record Updates

• Last Update Posted (Estimate): February 18, 2016
• Last Update Submitted That Met QC Criteria: January 20, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: CVD prevention; Lifestyle coaching; Phone-based system; Patient-centered decision support
• Additional Relevant MeSH Terms: Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cardiovascular Diseases; Cerebrovascular Disorders
• Other Study ID Numbers: CAPSYS-201205/08-1