Cardiovascular Diseases, Cerebrovascular Diseases, CVD Risk Factors, Stroke
Conditions
Keywords
Lifestyle coaching, Phone-based system, CVD prevention, Patient-centered decision support
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.
Interventions
BEHAVIORALStandard 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.
BEHAVIORALCAPSYS
In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
Sponsors
Centre Hospitalier du Luxembourg
Lübomira Spassova
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in BMI Value | baseline and 6 months |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fruits and Vegetables Consumption | baseline and 6 months | 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 | baseline and 6 months | 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 | baseline and 6 months | 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 | baseline and 6 months | Self-reported weekly duration of physical activity of medium or high intensity |
| Change in Quality of Life | baseline and 6 months | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Usability: SUS Score | 6 months | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 46 |
| Interventional Care (IC) CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week. | 48 |
| Total | 94 |
Baseline characteristics
| Characteristic | Standard Care (SC) | Interventional Care (IC) | Total |
|---|---|---|---|
| Age, Continuous | 59.6 years STANDARD_DEVIATION 12.1 | 60.7 years STANDARD_DEVIATION 11.3 | 60.2 years STANDARD_DEVIATION 11.6 |
| Sex: Female, Male Female | 17 Participants | 14 Participants | 31 Participants |
| Sex: Female, Male Male | 29 Participants | 34 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 46 | 0 / 48 |
| serious Total, serious adverse events | 0 / 46 | 0 / 48 |
Outcome results
Primary
Change in BMI Value
Time frame: baseline and 6 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care (SC) | Change in BMI Value | 0.05 kg/m^2 | Standard Deviation 1.61 |
| Interventional Care (IC) | Change in BMI Value | -0.26 kg/m^2 | Standard Deviation 1.3 |
Comparison: H0: no change between baseline and post-interventionp-value: 0.9t-test, 2 sided
Comparison: H0: no change between baseline and post-interventionp-value: 0.43t-test, 2 sided
Primary
Change in Glycaemia Level
Time frame: baseline and 6 months
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Care (SC) | Change in Glycaemia Level | -0.5 mg/dl |
| Interventional Care (IC) | Change in Glycaemia Level | -2 mg/dl |
Comparison: H0: no change between baseline and post-interventionp-value: 0.78Wilcoxon (Mann-Whitney)
Comparison: H0: no change between baseline and post-interventionp-value: 0.19Wilcoxon (Mann-Whitney)
Primary
Change in HbA1c Level
Time frame: baseline and 6 months
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Care (SC) | Change in HbA1c Level | -0.1 percent HbA1c |
| Interventional Care (IC) | Change in HbA1c Level | -0.1 percent HbA1c |
Comparison: H0: no change between baseline and post-interventionp-value: 0.92Wilcoxon (Mann-Whitney)
Comparison: H0: no change between baseline and post-interventionp-value: 0.37Wilcoxon (Mann-Whitney)
Primary
Change in HDL Level
Time frame: baseline and 6 months
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Care (SC) | Change in HDL Level | 1 mg/dl |
| Interventional Care (IC) | Change in HDL Level | -2 mg/dl |
Comparison: H0: no change between baseline and post-interventionp-value: 0.53Wilcoxon (Mann-Whitney)
Comparison: H0: no change between baseline and post-interventionp-value: 0.44Wilcoxon (Mann-Whitney)
Primary
Change in LDL Level
Time frame: baseline and 6 months
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Care (SC) | Change in LDL Level | -1 mg/dl |
| Interventional Care (IC) | Change in LDL Level | -6 mg/dl |
Comparison: H0: no change between baseline and post-interventionp-value: 0.76Wilcoxon (Mann-Whitney)
Comparison: H0: no change between baseline and post-interventionp-value: 0.04Wilcoxon (Mann-Whitney)
Primary
Change in Systolic Blood Pressure
Time frame: baseline and 6 months
Population: Blood pressure data is missing for 4 of the 36 SC and 4 of the 32 IC participants who provided final questionnaires.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care (SC) | Change in Systolic Blood Pressure | 0.19 mmHg | Standard Deviation 21.34 |
| Interventional Care (IC) | Change in Systolic Blood Pressure | -9 mmHg | Standard Deviation 21.37 |
Comparison: H0: no change between baseline and post-interventionp-value: 0.96t-test, 2 sided
Comparison: H0: no change between baseline and post-interventionp-value: 0.03t-test, 2 sided
Primary
Change in Triglyceride Level
Time frame: baseline and 6 months
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Care (SC) | Change in Triglyceride Level | -1 mg/dl |
| Interventional Care (IC) | Change in Triglyceride Level | -11 mg/dl |
Comparison: H0: no change between baseline and post-interventionp-value: 0.39Wilcoxon (Mann-Whitney)
Comparison: H0: no change between baseline and post-interventionp-value: 0.04Wilcoxon (Mann-Whitney)
Secondary
Change in Duration of Physical Activity
Self-reported weekly duration of physical activity of medium or high intensity
Time frame: baseline and 6 months
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Standard Care (SC) | Change in Duration of Physical Activity | medium intensity | 0 minutes |
| Standard Care (SC) | Change in Duration of Physical Activity | high intensity | 0 minutes |
| Interventional Care (IC) | Change in Duration of Physical Activity | medium intensity | 0 minutes |
| Interventional Care (IC) | Change in Duration of Physical Activity | high intensity | 0 minutes |
Comparison: Medium intensity~H0: no change between baseline and post-interventionp-value: 0.37Wilcoxon (Mann-Whitney)
Comparison: Medium intensity~H0: no change between baseline and post-interventionp-value: 0.34Wilcoxon (Mann-Whitney)
Comparison: High intensity~H0: no change between baseline and post-interventionp-value: 0.37Wilcoxon (Mann-Whitney)
Comparison: High intensity~H0: no change between baseline and post-interventionp-value: 0.59Wilcoxon (Mann-Whitney)
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.)
Time frame: baseline and 6 months
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Care (SC) | Change in Fruits and Vegetables Consumption | 0 portions |
| Interventional Care (IC) | Change in Fruits and Vegetables Consumption | 3.5 portions |
Comparison: H0: no change between baseline and post-interventionp-value: 0.67Wilcoxon (Mann-Whitney)
Comparison: H0: no change between baseline and post-interventionp-value: 0.04Wilcoxon (Mann-Whitney)
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).
Time frame: baseline and 6 months
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Care (SC) | Change in Quality of Life | 0 units on a scale (health value) |
| Interventional Care (IC) | Change in Quality of Life | 0 units on a scale (health value) |
Comparison: H0: no change between baseline and post-interventionp-value: 0.64Wilcoxon (Mann-Whitney)
Comparison: H0: no change between baseline and post-interventionp-value: 0.14Wilcoxon (Mann-Whitney)
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.)
Time frame: baseline and 6 months
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Care (SC) | Change in Sweets Consumption | 0 portions |
| Interventional Care (IC) | Change in Sweets Consumption | 0 portions |
Comparison: H0: no change between baseline and post-interventionp-value: 0.06Wilcoxon (Mann-Whitney)
Comparison: H0: no change between baseline and post-interventionp-value: 0.04Wilcoxon (Mann-Whitney)
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.)
Time frame: baseline and 6 months
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Care (SC) | Change in Whole Grain Food Consumption | 0 portions |
| Interventional Care (IC) | Change in Whole Grain Food Consumption | 1 portions |
Comparison: H0: no change between baseline and post-interventionp-value: 0.26Wilcoxon (Mann-Whitney)
Comparison: H0: no change between baseline and post-interventionp-value: 0.07Wilcoxon (Mann-Whitney)
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.
Time frame: 6 months
Population: SUS questionnaires are missing, incomplete or invalid for 6 of the 32 IC participants who provided final questionnaires.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care (SC) | Usability: SUS Score | 80.1 units on a scale (total SUS score) | Standard Deviation 16.22 |