Stroke Clinical Trial
— CAPSYSOfficial title:
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.
Status | Completed |
Enrollment | 94 |
Est. completion date | August 2014 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Lübomira Spassova | Centre Hospitalier du Luxembourg |
Spassova L, Vittore D, Droste D, Rösch N. Automated lifestyle coaching for cerebro-cardiovascular disease prevention. Stud Health Technol Inform. 2013;190:234-6. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | No |
Primary | Change in Systolic Blood Pressure | baseline and 6 months | No | |
Primary | Change in HDL Level | baseline and 6 months | No | |
Primary | Change in LDL Level | baseline and 6 months | No | |
Primary | Change in Triglyceride Level | baseline and 6 months | No | |
Primary | Change in HbA1c Level | baseline and 6 months | No | |
Primary | Change in Glycaemia Level | baseline and 6 months | No | |
Primary | Change in BMI Value | baseline and 6 months | No | |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | Change in Duration of Physical Activity | Self-reported weekly duration of physical activity of medium or high intensity | baseline and 6 months | No |
Secondary | 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 | No |
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