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Computer-Aided Prevention System (CAPSYS)

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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.
Interventional Care (IC) CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.

Participant Flow:   Overall Study
    Standard Care (SC)   Interventional Care (IC)
STARTED   46   48 
COMPLETED   36   32 
NOT COMPLETED   10   16 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Interventional Care (IC) CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
Total Total of all reporting groups

Baseline Measures
   Standard Care (SC)   Interventional Care (IC)   Total 
Overall Participants Analyzed 
[Units: Participants]
 46   48   94 
Age 
[Units: Years]
Mean (Standard Deviation)
 59.6  (12.1)   60.7  (11.3)   60.2  (11.6) 
Gender 
[Units: Participants]
     
Female   17   14   31 
Male   29   34   63 


  Outcome Measures

1.  Primary:   Change in Systolic Blood Pressure   [ Time Frame: baseline and 6 months ]

2.  Primary:   Change in HDL Level   [ Time Frame: baseline and 6 months ]

3.  Primary:   Change in LDL Level   [ Time Frame: baseline and 6 months ]

4.  Primary:   Change in Triglyceride Level   [ Time Frame: baseline and 6 months ]

5.  Primary:   Change in HbA1c Level   [ Time Frame: baseline and 6 months ]

6.  Primary:   Change in Glycaemia Level   [ Time Frame: baseline and 6 months ]

7.  Primary:   Change in BMI Value   [ Time Frame: baseline and 6 months ]

8.  Secondary:   Change in Fruits and Vegetables Consumption   [ Time Frame: baseline and 6 months ]

9.  Secondary:   Change in Whole Grain Food Consumption   [ Time Frame: baseline and 6 months ]

10.  Secondary:   Change in Sweets Consumption   [ Time Frame: baseline and 6 months ]

11.  Secondary:   Change in Duration of Physical Activity   [ Time Frame: baseline and 6 months ]

12.  Secondary:   Change in Quality of Life   [ Time Frame: baseline and 6 months ]

13.  Other Pre-specified:   Usability: SUS Score   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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:  
Name/Title: Dr. Lübomira Spassova
Organization: Luxembourg Institute of Science and Technology
phone: +352 275 888 1
e-mail: lubomira.spassova@list.lu


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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