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Stroke Education Intervention Trial - Pilot (AVAIL II)

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ClinicalTrials.gov Identifier: NCT01115660
Recruitment Status : Completed
First Posted : May 4, 2010
Results First Posted : January 24, 2013
Last Update Posted : October 14, 2015
Sponsor:
Collaborator:
Wake Forest University Health Sciences
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Ischemic Stroke
Intracranial Hemorrhage
Transient Ischemic Attack
Intervention Behavioral: stroke education
Enrollment 30
Recruitment Details Enrolled patients in 2010 at Wake Forest Baptist Medical Center
Pre-assignment Details Patients assigned to intervention arm and control arm, consecutively.
Arm/Group Title Stroke Education Control Arm
Hide Arm/Group Description Patients in this arm receive a telephone call by a medication coach who reviews their condition and importance of adherence to medication regimen. Patients received standard discharge counseling but no 2-week follow-up call.
Period Title: Overall Study
Started 20 10
Completed 19 10
Not Completed 1 0
Arm/Group Title Stroke Education Control Arm Total
Hide Arm/Group Description Patients in this arm receive a telephone call by a medication coach who reviews their condition and importance of adherence to medication regimen. Patients received standard discharge counseling but no 2-week follow-up call. Total of all reporting groups
Overall Number of Baseline Participants 20 10 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Median Age Number Analyzed 20 participants 10 participants 30 participants
61
(55 to 70)
59
(47 to 67)
61
(52 to 69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 10 participants 30 participants
Female
8
  40.0%
4
  40.0%
12
  40.0%
Male
12
  60.0%
6
  60.0%
18
  60.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 10 participants 30 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
10
  50.0%
3
  30.0%
13
  43.3%
White
9
  45.0%
7
  70.0%
16
  53.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   5.0%
0
   0.0%
1
   3.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 10 participants 30 participants
20 10 30
1.Primary Outcome
Title Feasibility of Intervention (Ability to Reach Patients at 3 Months)
Hide Description Number of patients contacted at 3 months
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who also were available at 3 months for post-intervention follow-up call.
Arm/Group Title Stroke Education Control
Hide Arm/Group Description:
Patients in this arm receive a telephone call by a medication coach who reviews their condition and importance of adherence to medication regimen.
standard of care
Overall Number of Participants Analyzed 19 10
Measure Type: Number
Unit of Measure: number of patients contacted
16 10
2.Secondary Outcome
Title Follow up Appointment With MD
Hide Description Follow up appointment with primary care provider since stroke
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients who were contacted at 3 months
Arm/Group Title Stroke Education Control
Hide Arm/Group Description:
Patients in this arm receive a telephone call by a medication coach who reviews their condition and importance of adherence to medication regimen.
standard of care
Overall Number of Participants Analyzed 16 10
Measure Type: Number
Unit of Measure: participants
15 7
Time Frame Adverse events were not collected
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Stroke Education Control Arm
Hide Arm/Group Description Patients in this arm receive a telephone call by a medication coach who reviews their condition and importance of adherence to medication regimen. Patients received standard discharge counseling but no 2-week follow-up call.
All-Cause Mortality
Stroke Education Control Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Stroke Education Control Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Stroke Education Control Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
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
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01115660     History of Changes
Other Study ID Numbers: Pro00019690
5U18HS016964 ( U.S. AHRQ Grant/Contract )
First Submitted: May 2, 2010
First Posted: May 4, 2010
Results First Submitted: August 10, 2012
Results First Posted: January 24, 2013
Last Update Posted: October 14, 2015