A Personalized Dashboard to Educate Veterans at Risk of Stroke

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01133171
First received: May 26, 2010
Last updated: October 28, 2015
Last verified: October 2015
Results First Received: March 31, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Open Label;   Primary Purpose: Health Services Research
Conditions: Cardiovascular Disease
Stroke
Interventions: Behavioral: Nurse Alone
Behavioral: Dashboard Plus Nurse

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Dashboard Plus Nurse No text entered.
Nurse Alone No text entered.
Control No text entered.

Participant Flow:   Overall Study
    Dashboard Plus Nurse     Nurse Alone     Control  
STARTED     25     27     25  
COMPLETED     24     25     25  
NOT COMPLETED     1     2     0  
Withdrawal by Subject                 1                 2                 0  



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Dashboard Plus Nurse No text entered.
Nurse Alone No text entered.
Control No text entered.
Total Total of all reporting groups

Baseline Measures
    Dashboard Plus Nurse     Nurse Alone     Control     Total  
Number of Participants  
[units: participants]
  24     25     25     74  
Age  
[units: years]
Mean (Standard Deviation)
  56.3  (9.2)     61.9  (12.5)     62.8  (10.5)     60  (10)  
Gender  
[units: participants]
       
Female     1     0     0     1  
Male     23     25     25     73  
Region of Enrollment  
[units: participants]
       
United States     24     25     25     74  



  Outcome Measures
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1.  Primary:   Change in Percentage of Participants Who Initiate Conversation With Primary Care Provider About Vascular Risk   [ Time Frame: From baseline to six-months ]

2.  Secondary:   Change in Systolic Blood Pressure   [ Time Frame: From baseline to six months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dawn M. Bravata, MD
Organization: Department of Veterans Affairs
phone: 317-988-2676
e-mail: dawn.bravata2@va.gov



Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01133171     History of Changes
Other Study ID Numbers: RRP 09-186
Study First Received: May 26, 2010
Results First Received: March 31, 2015
Last Updated: October 28, 2015
Health Authority: United States: Federal Government