Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Computer-Aided Prevention System (CAPSYS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02444715
Recruitment Status : Completed
First Posted : May 14, 2015
Results First Posted : August 24, 2015
Last Update Posted : February 18, 2016
Sponsor:
Collaborator:
Centre Hospitalier du Luxembourg
Information provided by (Responsible Party):
Lübomira Spassova, Luxembourg Institute of Science and Technology

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Cerebrovascular Diseases
Stroke
Cardiovascular Diseases
CVD Risk Factors
Interventions Behavioral: Standard care
Behavioral: CAPSYS
Enrollment 94
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Standard Care (SC) Interventional Care (IC)
Hide Arm/Group Description 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. CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
Period Title: Overall Study
Started 46 48
Completed 36 32
Not Completed 10 16
Arm/Group Title Standard Care (SC) Interventional Care (IC) Total
Hide Arm/Group Description 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. CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week. Total of all reporting groups
Overall Number of Baseline Participants 46 48 94
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 46 participants 48 participants 94 participants
59.6  (12.1) 60.7  (11.3) 60.2  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 48 participants 94 participants
Female
17
  37.0%
14
  29.2%
31
  33.0%
Male
29
  63.0%
34
  70.8%
63
  67.0%
1.Primary Outcome
Title Change in Systolic Blood Pressure
Hide Description [Not Specified]
Time Frame baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Blood pressure data is missing for 4 of the 36 SC and 4 of the 32 IC participants who provided final questionnaires.
Arm/Group Title Standard Care (SC) Interventional Care (IC)
Hide Arm/Group Description:
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.
CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
Overall Number of Participants Analyzed 32 28
Mean (Standard Deviation)
Unit of Measure: mmHg
0.19  (21.34) -9  (21.37)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Care (SC)
Comments H0: no change between baseline and post-intervention
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.96
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Interventional Care (IC)
Comments H0: no change between baseline and post-intervention
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title Change in HDL Level
Hide Description [Not Specified]
Time Frame baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Standard Care (SC) Interventional Care (IC)
Hide Arm/Group Description:
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.
CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
Overall Number of Participants Analyzed 41 37
Median (Inter-Quartile Range)
Unit of Measure: mg/dl
1
(-5 to 7)
-2
(-7 to 4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Care (SC)
Comments H0: no change between baseline and post-intervention
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Interventional Care (IC)
Comments H0: no change between baseline and post-intervention
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.44
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Primary Outcome
Title Change in LDL Level
Hide Description [Not Specified]
Time Frame baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Standard Care (SC) Interventional Care (IC)
Hide Arm/Group Description:
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.
CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
Overall Number of Participants Analyzed 41 37
Median (Inter-Quartile Range)
Unit of Measure: mg/dl
-1
(-17 to 10)
-6
(-16 to 3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Care (SC)
Comments H0: no change between baseline and post-intervention
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.76
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Interventional Care (IC)
Comments H0: no change between baseline and post-intervention
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Primary Outcome
Title Change in Triglyceride Level
Hide Description [Not Specified]
Time Frame baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Standard Care (SC) Interventional Care (IC)
Hide Arm/Group Description:
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.
CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
Overall Number of Participants Analyzed 30 32
Median (Inter-Quartile Range)
Unit of Measure: mg/dl
-1
(-33.25 to 18)
-11
(-37.5 to 10.25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Care (SC)
Comments H0: no change between baseline and post-intervention
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.39
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Interventional Care (IC)
Comments H0: no change between baseline and post-intervention
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Primary Outcome
Title Change in HbA1c Level
Hide Description [Not Specified]
Time Frame baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Standard Care (SC) Interventional Care (IC)
Hide Arm/Group Description:
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.
CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
Overall Number of Participants Analyzed 25 27
Median (Inter-Quartile Range)
Unit of Measure: percent HbA1c
-0.1
(-0.2 to 0.2)
-0.1
(-0.2 to 0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Care (SC)
Comments H0: no change between baseline and post-intervention
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.92
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Interventional Care (IC)
Comments H0: no change between baseline and post-intervention
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.37
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Primary Outcome
Title Change in Glycaemia Level
Hide Description [Not Specified]
Time Frame baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Standard Care (SC) Interventional Care (IC)
Hide Arm/Group Description:
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.
CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
Overall Number of Participants Analyzed 40 35
Median (Inter-Quartile Range)
Unit of Measure: mg/dl
-0.5
(-8.25 to 6)
-2
(-7.5 to 2.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Care (SC)
Comments H0: no change between baseline and post-intervention
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.78
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Interventional Care (IC)
Comments H0: no change between baseline and post-intervention
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.19
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
7.Primary Outcome
Title Change in BMI Value
Hide Description [Not Specified]
Time Frame baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Standard Care (SC) Interventional Care (IC)
Hide Arm/Group Description:
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.
CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
Overall Number of Participants Analyzed 37 33
Mean (Standard Deviation)
Unit of Measure: kg/m^2
0.05  (1.61) -0.26  (1.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Care (SC)
Comments H0: no change between baseline and post-intervention
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Interventional Care (IC)
Comments H0: no change between baseline and post-intervention
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.43
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
8.Secondary Outcome
Title Change in Fruits and Vegetables Consumption
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Standard Care (SC) Interventional Care (IC)
Hide Arm/Group Description:
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.
CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
Overall Number of Participants Analyzed 36 32
Median (Inter-Quartile Range)
Unit of Measure: portions
0
(-7 to 7)
3.5
(-3.25 to 11.75)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Care (SC)
Comments H0: no change between baseline and post-intervention
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.67
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Interventional Care (IC)
Comments H0: no change between baseline and post-intervention
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
9.Secondary Outcome
Title Change in Whole Grain Food Consumption
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Standard Care (SC) Interventional Care (IC)
Hide Arm/Group Description:
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.
CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
Overall Number of Participants Analyzed 36 32
Median (Inter-Quartile Range)
Unit of Measure: portions
0
(-4 to 3)
1
(-0.25 to 7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Care (SC)
Comments H0: no change between baseline and post-intervention
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Interventional Care (IC)
Comments H0: no change between baseline and post-intervention
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
10.Secondary Outcome
Title Change in Sweets Consumption
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Standard Care (SC) Interventional Care (IC)
Hide Arm/Group Description:
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.
CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
Overall Number of Participants Analyzed 36 32
Median (Inter-Quartile Range)
Unit of Measure: portions
0
(0 to 1)
0
(0 to 2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Care (SC)
Comments H0: no change between baseline and post-intervention
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Interventional Care (IC)
Comments H0: no change between baseline and post-intervention
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
11.Secondary Outcome
Title Change in Duration of Physical Activity
Hide Description Self-reported weekly duration of physical activity of medium or high intensity
Time Frame baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Standard Care (SC) Interventional Care (IC)
Hide Arm/Group Description:
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.
CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
Overall Number of Participants Analyzed 36 32
Median (Inter-Quartile Range)
Unit of Measure: minutes
medium intensity
0
(-60 to 135)
0
(-60 to 112.5)
high intensity
0
(-120 to 15)
0
(-45 to 30)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Care (SC)
Comments

Medium intensity

H0: no change between baseline and post-intervention

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.37
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Interventional Care (IC)
Comments

Medium intensity

H0: no change between baseline and post-intervention

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.34
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Standard Care (SC)
Comments

High intensity

H0: no change between baseline and post-intervention

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.37
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Interventional Care (IC)
Comments

High intensity

H0: no change between baseline and post-intervention

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.59
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
12.Secondary Outcome
Title Change in Quality of Life
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Standard Care (SC) Interventional Care (IC)
Hide Arm/Group Description:
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.
CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
Overall Number of Participants Analyzed 36 32
Median (Inter-Quartile Range)
Unit of Measure: units on a scale (health value)
0
(-6.25 to 10)
0
(-0.25 to 5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Care (SC)
Comments H0: no change between baseline and post-intervention
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.64
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Interventional Care (IC)
Comments H0: no change between baseline and post-intervention
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.14
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
13.Other Pre-specified Outcome
Title Usability: SUS Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
SUS questionnaires are missing, incomplete or invalid for 6 of the 32 IC participants who provided final questionnaires.
Arm/Group Title Interventional Care (IC)
Hide Arm/Group Description:
CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
Overall Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: units on a scale (total SUS score)
80.1  (16.22)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard Care (SC) Interventional Care (IC)
Hide Arm/Group Description 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. CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
All-Cause Mortality
Standard Care (SC) Interventional Care (IC)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Standard Care (SC) Interventional Care (IC)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/46 (0.00%)   0/48 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard Care (SC) Interventional Care (IC)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/46 (0.00%)   0/48 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Lübomira Spassova
Organization: Luxembourg Institute of Science and Technology
Phone: +352 275 888 1
EMail: lubomira.spassova@list.lu
Layout table for additonal information
Responsible Party: Lübomira Spassova, Luxembourg Institute of Science and Technology
ClinicalTrials.gov Identifier: NCT02444715     History of Changes
Other Study ID Numbers: CAPSYS-201205/08-1
First Submitted: May 12, 2015
First Posted: May 14, 2015
Results First Submitted: June 8, 2015
Results First Posted: August 24, 2015
Last Update Posted: February 18, 2016