Stroke Education Intervention Trial - Pilot (AVAIL II)

This study has been completed.

Sponsor:

Collaborator:

Wake Forest University Baptist Medical Center

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

History of Changes

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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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 ]

Show Outcome Measure 1

2. Secondary:

Follow up Appointment With MD [ Time Frame: 3 months ]

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Serious Adverse Events

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Other Adverse Events

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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.

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
Adverse events not collected

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

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