Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Centre Hospitalier du Luxembourg | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard care (SC) | Active Comparator |
| |
| Interventional care (IC) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard care | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Systolic Blood Pressure | baseline and 6 months | |
| Change in HDL Level | baseline and 6 months | |
| Change in LDL Level | baseline and 6 months | |
| Change in Triglyceride Level | baseline and 6 months | |
| Change in HbA1c Level | baseline and 6 months | |
| Change in Glycaemia Level | baseline and 6 months | |
| Change in BMI Value | baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
At high risk of stroke:
Already suffered a stroke or Transient Ischemic Attack (TIA) or
At least two risk factors for stroke:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lübomira Spassova, Dr.-Ing. | Luxembourg Institute of Science and Technology | Study Chair |
| Debora Vittore | Centre Hospitalier de Luxembourg (CHL) | Study Chair |
| Dirk W Droste, Prof. Dr. | Centre Hospitalier de Luxembourg (CHL) | Principal Investigator |
| Norbert Rösch, Prof. Dr. | University of Applied Sciences Kaiserslautern | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23823433 | Background | Spassova L, Vittore D, Droste D, Rosch N. Automated lifestyle coaching for cerebro-cardiovascular disease prevention. Stud Health Technol Inform. 2013;190:234-6. | |
| 34813082 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Standard Care (SC) | 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. |
| FG001 | Interventional Care (IC) | CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Standard Care (SC) | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Systolic Blood Pressure | Blood pressure data is missing for 4 of the 36 SC and 4 of the 32 IC participants who provided final questionnaires. | Posted | Mean | Standard Deviation | mmHg | baseline and 6 months |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Care (SC) | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lübomira Spassova | Luxembourg Institute of Science and Technology | +352 275 888 1 | lubomira.spassova@list.lu |
Not provided
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D020521 | Stroke |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| CAPSYS | Behavioral | In addition to the usual care, patients are asked to call the CAPSYS system twice a week. |
|
| 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 |
| 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 |
| Change in Duration of Physical Activity | Self-reported weekly duration of physical activity of medium or high intensity | 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"). | baseline and 6 months |
| 6 months |
| 26861865 | Derived | 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. |
| Interventional Care (IC) |
CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| Primary | Change in HDL Level | For participants who did not provide final questionnaires, data was retrieved from medical records. HDL data is missing for 5 of the 46 SC and 11 of the 48 IC participants who started the study. | Posted | Median | Inter-Quartile Range | mg/dl | baseline and 6 months |
|
|
|
|
| Primary | Change in LDL Level | For participants who did not provide final questionnaires, data was retrieved from medical records. LDL data is missing for 5 of the 46 SC and 11 of the 48 IC participants who started the study. | Posted | Median | Inter-Quartile Range | mg/dl | baseline and 6 months |
|
|
|
|
| Primary | Change in Triglyceride Level | For participants who did not provide final questionnaires, data was retrieved from medical records. Triglyceride data is missing for 16 of the 46 SC and 16 of the 48 IC participants who started the study. | Posted | Median | Inter-Quartile Range | mg/dl | baseline and 6 months |
|
|
|
|
| Primary | Change in HbA1c Level | For participants who did not provide final questionnaires, data was retrieved from medical records. HbA1c data is missing for 21 of the 46 SC and 21 of the 48 IC participants who started the study. | Posted | Median | Inter-Quartile Range | percent HbA1c | baseline and 6 months |
|
|
|
|
| Primary | Change in Glycaemia Level | For participants who did not provide final questionnaires, data was retrieved from medical records. Glycaemia data is missing for 6 of the 46 SC and 13 of the 48 IC participants who started the study. | Posted | Median | Inter-Quartile Range | mg/dl | baseline and 6 months |
|
|
|
|
| Primary | Change in BMI Value | For participants who did not provide final questionnaires, data was retrieved from medical records. Weight data is missing for 9 of the 46 SC and 15 of the 48 IC participants who started the study. | Posted | Mean | Standard Deviation | kg/m^2 | baseline and 6 months |
|
|
|
|
| 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.) | Data on fruits and vegetables consumption was retrieved from final questionnaires. Hence, food consumption data is missing for the 10 SC and 16 IC participants who did not provide final questionnaires. | Posted | Median | Inter-Quartile Range | portions | baseline and 6 months |
|
|
|
|
| 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.) | Data on whole grain food consumption was retrieved from final questionnaires. Hence, food consumption data is missing for the 10 SC and 16 IC participants who did not provide final questionnaires. | Posted | Median | Inter-Quartile Range | portions | baseline and 6 months |
|
|
|
|
| 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.) | Data on sweets consumption was retrieved from final questionnaires. Hence, food consumption data is missing for the 10 SC and 16 IC participants who did not provide final questionnaires. | Posted | Median | Inter-Quartile Range | portions | baseline and 6 months |
|
|
|
|
| Secondary | Change in Duration of Physical Activity | Self-reported weekly duration of physical activity of medium or high intensity | Data on physical activity was retrieved from final questionnaires. Hence, physical activity data is missing for the 10 SC and 16 IC participants who did not provide final questionnaires. | Posted | Median | Inter-Quartile Range | minutes | baseline and 6 months |
|
|
|
|
| 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"). | Data on quality of life was retrieved from final questionnaires. Hence, QoL data is missing for the 10 SC and 16 IC participants who did not provide final questionnaires. | Posted | Median | Inter-Quartile Range | units on a scale (health value) | baseline and 6 months |
|
|
|
|
| Other Pre-specified | 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. | SUS questionnaires are missing, incomplete or invalid for 6 of the 32 IC participants who provided final questionnaires. | Posted | Mean | Standard Deviation | units on a scale (total SUS score) | 6 months |
|
|
|
| 0 |
| 46 |
| 0 |
| 46 |
| EG001 | Interventional Care (IC) | CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week. | 0 | 48 | 0 | 48 |
Not provided
Not provided
| 0.44 |
| 2-Sided |
| No |
| Superiority or Other |
| 0.04 |
| 2-Sided |
| No |
| Superiority or Other |
| 0.04 |
| 2-Sided |
| No |
| Superiority or Other |
| 0.37 |
| 2-Sided |
| No |
| Superiority or Other |
| 0.19 |
| 2-Sided |
| No |
| Superiority or Other |
| 0.43 |
| 2-Sided |
| No |
| Superiority or Other |
| 0.04 |
| 2-Sided |
| No |
| Superiority or Other |
| 0.07 |
| 2-Sided |
| No |
| Superiority or Other |
| 0.04 |
| 2-Sided |
| No |
| Superiority or Other |
| 0.34 |
| 2-Sided |
| No |
| Superiority or Other |
| High intensity H0: no change between baseline and post-intervention | Wilcoxon (Mann-Whitney) | 0.37 | 2-Sided | No | Superiority or Other |
| High intensity H0: no change between baseline and post-intervention | Wilcoxon (Mann-Whitney) | 0.59 | 2-Sided | No | Superiority or Other |
| 0.14 |
| 2-Sided |
| No |
| Superiority or Other |