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Computer-Aided Prevention System (CAPSYS)

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ClinicalTrials.gov Identifier: NCT02444715
Recruitment Status : Completed
First Posted : May 14, 2015
Results First Posted : August 24, 2015
Last Update Posted : February 18, 2016
Sponsor:
Collaborator:
Centre Hospitalier du Luxembourg
Information provided by (Responsible Party):
Lübomira Spassova, Luxembourg Institute of Science and Technology

Tracking Information
First Submitted Date  ICMJE May 12, 2015
First Posted Date  ICMJE May 14, 2015
Results First Submitted Date  ICMJE June 8, 2015
Results First Posted Date  ICMJE August 24, 2015
Last Update Posted Date February 18, 2016
Study Start Date  ICMJE January 2013
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2015)
  • Change in Systolic Blood Pressure [ Time Frame: baseline and 6 months ]
  • Change in HDL Level [ Time Frame: baseline and 6 months ]
  • Change in LDL Level [ Time Frame: baseline and 6 months ]
  • Change in Triglyceride Level [ Time Frame: baseline and 6 months ]
  • Change in HbA1c Level [ Time Frame: baseline and 6 months ]
  • Change in Glycaemia Level [ Time Frame: baseline and 6 months ]
  • Change in BMI Value [ Time Frame: baseline and 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02444715 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2015)
  • Change in Fruits and Vegetables Consumption [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: baseline and 6 months ]
    Self-reported weekly duration of physical activity of medium or high intensity
  • Change in Quality of Life [ Time Frame: 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").
Original Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2015)
  • Change in Fruits and Vegetables Consumption [ Time Frame: baseline and 6 months ]
    Self-reported daily or weekly portions
  • Change in Whole Grain Food Consumption [ Time Frame: baseline and 6 months ]
    Self-reported daily or weekly portions
  • Change in Sweets Consumption [ Time Frame: baseline and 6 months ]
    Self-reported daily or weekly portions
  • Change in Duration of Physical Activity [ Time Frame: baseline and 6 months ]
    Self-reported weekly duration of physical activity of low, medium or high intensity
  • Change in Quality of Life [ Time Frame: baseline and 6 months ]
    The QoL was measured using the standardised EQ-5D-5L instrument provided by the EuroQol Group.
Current Other Pre-specified Outcome Measures
 (submitted: December 16, 2015)
Usability: SUS Score [ Time Frame: 6 months ]
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.
Original Other Pre-specified Outcome Measures
 (submitted: May 13, 2015)
Usability: SUS Score [ Time Frame: 6 months ]
The usability of the intervention was assessed based on the standardised System Usability Scale (SUS).
 
Descriptive Information
Brief Title  ICMJE Computer-Aided Prevention System
Official Title  ICMJE Study on Improved Prevention Methods for Cerebro-cardiovascular Diseases Based on a Computer-aided Prevention System
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Cerebrovascular Diseases
  • Stroke
  • Cardiovascular Diseases
  • CVD Risk Factors
Intervention  ICMJE
  • 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.
  • Behavioral: CAPSYS
    In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
Study Arms  ICMJE
  • Active Comparator: Standard care (SC)
    Intervention: Behavioral: Standard care
  • Experimental: Interventional care (IC)
    Intervention: Behavioral: CAPSYS
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 13, 2015)
94
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02444715
Other Study ID Numbers  ICMJE CAPSYS-201205/08-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lübomira Spassova, Luxembourg Institute of Science and Technology
Study Sponsor  ICMJE Lübomira Spassova
Collaborators  ICMJE Centre Hospitalier du Luxembourg
Investigators  ICMJE
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
PRS Account Luxembourg Institute of Science and Technology
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP