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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

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.


Condition or disease Intervention/treatment Phase
Cerebrovascular Diseases Stroke Cardiovascular Diseases CVD Risk Factors Behavioral: Standard care Behavioral: CAPSYS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Study on Improved Prevention Methods for Cerebro-cardiovascular Diseases Based on a Computer-aided Prevention System
Study Start Date : January 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

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.




Primary Outcome Measures :
  1. Change in Systolic Blood Pressure [ Time Frame: baseline and 6 months ]
  2. Change in HDL Level [ Time Frame: baseline and 6 months ]
  3. Change in LDL Level [ Time Frame: baseline and 6 months ]
  4. Change in Triglyceride Level [ Time Frame: baseline and 6 months ]
  5. Change in HbA1c Level [ Time Frame: baseline and 6 months ]
  6. Change in Glycaemia Level [ Time Frame: baseline and 6 months ]
  7. Change in BMI Value [ Time Frame: baseline and 6 months ]

Secondary Outcome Measures :
  1. 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.)


  2. 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.)


  3. 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.)


  4. Change in Duration of Physical Activity [ Time Frame: baseline and 6 months ]
    Self-reported weekly duration of physical activity of medium or high intensity

  5. 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").



Other Outcome Measures:
  1. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02444715


Sponsors and Collaborators
Lübomira Spassova
Centre Hospitalier du Luxembourg
Investigators
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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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lübomira Spassova, Dr.-Ing., Luxembourg Institute of Science and Technology
ClinicalTrials.gov Identifier: NCT02444715     History of Changes
Other Study ID Numbers: CAPSYS-201205/08-1
First Posted: May 14, 2015    Key Record Dates
Results First Posted: August 24, 2015
Last Update Posted: February 18, 2016
Last Verified: January 2016

Keywords provided by Lübomira Spassova, Luxembourg Institute of Science and Technology:
Lifestyle coaching
Phone-based system
CVD prevention
Patient-centered decision support

Additional relevant MeSH terms:
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Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases