Stroke Education Intervention Trial - Pilot (AVAIL II)

This study has been completed.
Sponsor:
Collaborator:
Wake Forest Baptist Health
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01115660
First received: May 2, 2010
Last updated: December 14, 2012
Last verified: December 2012
Results First Received: August 10, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Ischemic Stroke
Intracranial Hemorrhage
Transient Ischemic Attack
Intervention: Behavioral: stroke education

  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
Enrolled patients in 2010 at Wake Forest Baptist Medical Center

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients assigned to intervention arm and control arm, consecutively.

Reporting Groups
  Description
Stroke Education Patients in this arm receive a telephone call by a medication coach who reviews their condition and importance of adherence to medication regimen.
Control Arm Patients received standard discharge counseling but no 2-week follow-up call.

Participant Flow:   Overall Study
    Stroke Education     Control Arm  
STARTED     20     10  
COMPLETED     19     10  
NOT COMPLETED     1     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.
No text entered.

Reporting Groups
  Description
Stroke Education Patients in this arm receive a telephone call by a medication coach who reviews their condition and importance of adherence to medication regimen.
Control Arm Patients received standard discharge counseling but no 2-week follow-up call.
Total Total of all reporting groups

Baseline Measures
    Stroke Education     Control Arm     Total  
Number of Participants  
[units: participants]
  20     10     30  
Age  
[units: years]
Median ( Inter-Quartile Range )
     
Median Age     61  
  ( 55 to 70 )  
  59  
  ( 47 to 67 )  
  61  
  ( 52 to 69 )  
Gender  
[units: participants]
     
Female     8     4     12  
Male     12     6     18  
Race (NIH/OMB)  
[units: Participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     10     3     13  
White     9     7     16  
More than one race     0     0     0  
Unknown or Not Reported     1     0     1  
Region of Enrollment  
[units: participants]
     
United States     20     10     30  



  Outcome Measures
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1.  Primary:   Feasibility of Intervention (Ability to Reach Patients at 3 Months)   [ Time Frame: 3 months ]

2.  Secondary:   Follow up Appointment With MD   [ Time Frame: 3 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
Adverse events not collected


  More Information
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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. Cheryl Bushnell
Organization: Wake Forest School of Medicine
phone: (336) 716-2357
e-mail: cbushnel@wakehealth.edu


No publications provided


Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01115660     History of Changes
Other Study ID Numbers: Pro00019690, 5U18HS016964
Study First Received: May 2, 2010
Results First Received: August 10, 2012
Last Updated: December 14, 2012
Health Authority: United States: Institutional Review Board