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Computer-Aided Prevention System (CAPSYS)

Primary Purpose

Cerebrovascular Diseases, Stroke, Cardiovascular Diseases

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Standard care
CAPSYS
Sponsored by
Lübomira Spassova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cerebrovascular Diseases focused on measuring Lifestyle coaching, Phone-based system, CVD prevention, Patient-centered decision support

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Standard care (SC)

    Interventional care (IC)

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change in Systolic Blood Pressure
    Change in HDL Level
    Change in LDL Level
    Change in Triglyceride Level
    Change in HbA1c Level
    Change in Glycaemia Level
    Change in BMI Value

    Secondary Outcome Measures

    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.)
    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.)
    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.)
    Change in Duration of Physical Activity
    Self-reported weekly duration of physical activity of medium or high intensity
    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").

    Full Information

    First Posted
    May 12, 2015
    Last Updated
    January 20, 2016
    Sponsor
    Lübomira Spassova
    Collaborators
    Centre Hospitalier du Luxembourg
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02444715
    Brief Title
    Computer-Aided Prevention System
    Acronym
    CAPSYS
    Official Title
    Study on Improved Prevention Methods for Cerebro-cardiovascular Diseases Based on a Computer-aided Prevention System
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2013 (undefined)
    Primary Completion Date
    August 2014 (Actual)
    Study Completion Date
    August 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Lübomira Spassova
    Collaborators
    Centre Hospitalier du Luxembourg

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebrovascular Diseases, Stroke, Cardiovascular Diseases, CVD Risk Factors
    Keywords
    Lifestyle coaching, Phone-based system, CVD prevention, Patient-centered decision support

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    94 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard care (SC)
    Arm Type
    Active Comparator
    Arm Title
    Interventional care (IC)
    Arm Type
    Experimental
    Intervention Type
    Behavioral
    Intervention Name(s)
    Standard care
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    CAPSYS
    Intervention Description
    In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
    Primary Outcome Measure Information:
    Title
    Change in Systolic Blood Pressure
    Time Frame
    baseline and 6 months
    Title
    Change in HDL Level
    Time Frame
    baseline and 6 months
    Title
    Change in LDL Level
    Time Frame
    baseline and 6 months
    Title
    Change in Triglyceride Level
    Time Frame
    baseline and 6 months
    Title
    Change in HbA1c Level
    Time Frame
    baseline and 6 months
    Title
    Change in Glycaemia Level
    Time Frame
    baseline and 6 months
    Title
    Change in BMI Value
    Time Frame
    baseline and 6 months
    Secondary Outcome Measure Information:
    Title
    Change in Fruits and Vegetables Consumption
    Description
    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.)
    Time Frame
    baseline and 6 months
    Title
    Change in Whole Grain Food Consumption
    Description
    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.)
    Time Frame
    baseline and 6 months
    Title
    Change in Sweets Consumption
    Description
    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.)
    Time Frame
    baseline and 6 months
    Title
    Change in Duration of Physical Activity
    Description
    Self-reported weekly duration of physical activity of medium or high intensity
    Time Frame
    baseline and 6 months
    Title
    Change in Quality of Life
    Description
    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").
    Time Frame
    baseline and 6 months
    Other Pre-specified Outcome Measures:
    Title
    Usability: SUS Score
    Description
    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.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lübomira Spassova, Dr.-Ing.
    Organizational Affiliation
    Luxembourg Institute of Science and Technology
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Debora Vittore
    Organizational Affiliation
    Centre Hospitalier de Luxembourg (CHL)
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Dirk W Droste, Prof. Dr.
    Organizational Affiliation
    Centre Hospitalier de Luxembourg (CHL)
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Norbert Rösch, Prof. Dr.
    Organizational Affiliation
    University of Applied Sciences Kaiserslautern
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23823433
    Citation
    Spassova L, Vittore D, Droste D, Rosch N. Automated lifestyle coaching for cerebro-cardiovascular disease prevention. Stud Health Technol Inform. 2013;190:234-6.
    Results Reference
    background
    PubMed Identifier
    34813082
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    26861865
    Citation
    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.
    Results Reference
    derived

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