An interventional study of Standard care and CAPSYS in Cerebrovascular Diseases, Stroke and Cardiovascular Diseases, sponsored by Lübomira Spassova. Completed. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2016-02-18.
Sponsored by Lübomira Spassova · Not applicable, Interventional, and Prevention
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.
385 studies on the registry are indexed under Cerebrovascular Disorders; 129 are open to participants now.
This study's enrollment of 94 is below the median of 109 across 224 interventional studies indexed under Cerebrovascular Disorders.
Browse Cerebrovascular Disorders studies →This is the only study on the registry with Lübomira Spassova as lead sponsor.
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At high risk of stroke:
At least two risk factors for stroke:
Exclusion Criteria:
Behavioral: Standard care
Behavioral: CAPSYS
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.
In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
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
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.)
Time frame: baseline and 6 months
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.)
Time frame: baseline and 6 months
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.)
Time frame: baseline and 6 months
Change in Duration of Physical Activity
Self-reported weekly duration of physical activity of medium or high intensity
Time frame: baseline and 6 months
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").
Time frame: baseline and 6 months
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.
Time frame: 6 months
| Milestone | Standard Care (SC) | Interventional Care (IC) |
|---|---|---|
| Started | 46 | 48 |
| Completed | 36 | 32 |
| Not completed | 10 | 16 |
| mmHg | Standard Care (SC) | Interventional Care (IC) |
|---|---|---|
| Change in Systolic Blood Pressure | 0.19 ± 21.34 | -9 ± 21.37 |
| mg/dl | Standard Care (SC) | Interventional Care (IC) |
|---|---|---|
| Change in HDL Level | 1 (-5 to 7) | -2 (-7 to 4) |
| mg/dl | Standard Care (SC) | Interventional Care (IC) |
|---|---|---|
| Change in LDL Level | -1 (-17 to 10) | -6 (-16 to 3) |
| mg/dl | Standard Care (SC) | Interventional Care (IC) |
|---|---|---|
| Change in Triglyceride Level | -1 (-33.25 to 18) | -11 (-37.5 to 10.25) |
| percent HbA1c | Standard Care (SC) | Interventional Care (IC) |
|---|---|---|
| Change in HbA1c Level | -0.1 (-0.2 to 0.2) | -0.1 (-0.2 to 0) |
| mg/dl | Standard Care (SC) | Interventional Care (IC) |
|---|---|---|
| Change in Glycaemia Level | -0.5 (-8.25 to 6) | -2 (-7.5 to 2.5) |
| kg/m^2 | Standard Care (SC) | Interventional Care (IC) |
|---|---|---|
| Change in BMI Value | 0.05 ± 1.61 | -0.26 ± 1.3 |
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.)
| portions | Standard Care (SC) | Interventional Care (IC) |
|---|---|---|
| Change in Fruits and Vegetables Consumption | 0 (-7 to 7) | 3.5 (-3.25 to 11.75) |
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.)
| portions | Standard Care (SC) | Interventional Care (IC) |
|---|---|---|
| Change in Whole Grain Food Consumption | 0 (-4 to 3) | 1 (-0.25 to 7) |
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.)
| portions | Standard Care (SC) | Interventional Care (IC) |
|---|---|---|
| Change in Sweets Consumption | 0 (0 to 1) | 0 (0 to 2) |
Self-reported weekly duration of physical activity of medium or high intensity
| minutes | Standard Care (SC) | Interventional Care (IC) |
|---|---|---|
| medium intensity | 0 (-60 to 135) | 0 (-60 to 112.5) |
| high intensity | 0 (-120 to 15) | 0 (-45 to 30) |
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").
| units on a scale (health value) | Standard Care (SC) | Interventional Care (IC) |
|---|---|---|
| Change in Quality of Life | 0 (-6.25 to 10) | 0 (-0.25 to 5) |
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.
| units on a scale (total SUS score) | Interventional Care (IC) |
|---|---|
| Usability: SUS Score | 80.1 ± 16.22 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard Care (SC) | — | 0/46 (0%) | 0/46 (0%) |
| Interventional Care (IC) | — | 0/48 (0%) | 0/48 (0%) |
| Age, Continuous(years) | Standard Care (SC) | Interventional Care (IC) | Total |
|---|---|---|---|
| Mean | 59.6 ± 12.1 | 60.7 ± 11.3 | 60.2 ± 11.6 |
| Sex: Female, Male(Participants) | Standard Care (SC) | Interventional Care (IC) | Total |
|---|---|---|---|
| Female | 17 | 14 | 31 |
| Male | 29 | 34 | 63 |
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This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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