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
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
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
NCT ID
NCT02444715
First Posted
May 12, 2015
Last Updated
January 20, 2016
Sponsor
Lübomira Spassova
Collaborators
Centre Hospitalier du Luxembourg
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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Computer-Aided Prevention System
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