Back to resultsStroke Education Intervention Trial - Pilot (AVAIL II)
Primary Purpose
Ischemic Stroke, Intracranial Hemorrhage, Transient Ischemic Attack
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
stroke education
Sponsored by
About this trial
This is an interventional prevention trial for Ischemic Stroke focused on measuring stroke, patient education, medication adherence
Eligibility Criteria
Inclusion Criteria:
- Patients at Wake Forest University Baptist Medical Center (WFUBMC) over age 18
- Diagnosed with acute ischemic stroke, transient ischemic attack or intracranial hemorrhage
- provide consent to participate
Exclusion Criteria:
- discharged to nursing home, acute rehabilitation center, inpatient hospice, or other acute hospital
- homeless
- non-English speakers
- patient and proxy unable to participate in telephone conversation
Sites / Locations
- WFUBMC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
stroke education
control arm
Arm Description
Patients in this arm receive a telephone call by a medication coach who reviews their condition and importance of adherence to medication regimen.
Subjects in this arm received instruction at hospital discharge and a 3-month follow-up call to collect study data.
Outcomes
Primary Outcome Measures
Feasibility of Intervention (Ability to Reach Patients at 3 Months)
Number of patients contacted at 3 months
Secondary Outcome Measures
Follow up Appointment With MD
Follow up appointment with primary care provider since stroke
Full Information
NCT ID
NCT01115660
First Posted
May 2, 2010
Last Updated
October 11, 2015
Sponsor
Duke University
Collaborators
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01115660
Brief Title
Stroke Education Intervention Trial - Pilot
Acronym
AVAIL II
Official Title
AVAIL interVention Trial (Adherence Evaluation After Ischemic Stroke - Longitudinal): Pilot Protocol
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Wake Forest University Health Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objectives of the trial of a medication-coach program for patients with stroke or transient ischemic attack are to pilot test the study design, the intervention components and the data collection forms and refine them for a larger trial whose goal will be to improve long-term adherence to stroke prevention medications.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Intracranial Hemorrhage, Transient Ischemic Attack
Keywords
stroke, patient education, medication adherence
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
stroke education
Arm Type
Experimental
Arm Description
Patients in this arm receive a telephone call by a medication coach who reviews their condition and importance of adherence to medication regimen.
Arm Title
control arm
Arm Type
No Intervention
Arm Description
Subjects in this arm received instruction at hospital discharge and a 3-month follow-up call to collect study data.
Intervention Type
Behavioral
Intervention Name(s)
stroke education
Intervention Description
call by medication coach 2 weeks after hospital discharge
Primary Outcome Measure Information:
Title
Feasibility of Intervention (Ability to Reach Patients at 3 Months)
Description
Number of patients contacted at 3 months
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Follow up Appointment With MD
Description
Follow up appointment with primary care provider since stroke
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients at Wake Forest University Baptist Medical Center (WFUBMC) over age 18
Diagnosed with acute ischemic stroke, transient ischemic attack or intracranial hemorrhage
provide consent to participate
Exclusion Criteria:
discharged to nursing home, acute rehabilitation center, inpatient hospice, or other acute hospital
homeless
non-English speakers
patient and proxy unable to participate in telephone conversation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric D Peterson, MD, MPH
Organizational Affiliation
DCRI
Official's Role
Principal Investigator
Facility Information:
Facility Name
WFUBMC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22830539
Citation
Sides EG, Zimmer LO, Wilson L, Pan W, Olson DM, Peterson ED, Bushnell C. Medication coaching program for patients with minor stroke or TIA: a pilot study. BMC Public Health. 2012 Jul 25;12:549. doi: 10.1186/1471-2458-12-549.
Results Reference
result
Learn more about this trial
Stroke Education Intervention Trial - Pilot
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