Stroke Education Intervention Trial - Pilot (AVAIL II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01115660
Recruitment Status : Completed
First Posted : May 4, 2010
Results First Posted : January 24, 2013
Last Update Posted : October 14, 2015
Wake Forest University Health Sciences
Information provided by (Responsible Party):
Duke University

May 2, 2010
May 4, 2010
August 10, 2012
January 24, 2013
October 14, 2015
January 2010
June 2011   (Final data collection date for primary outcome measure)
Feasibility of Intervention (Ability to Reach Patients at 3 Months) [ Time Frame: 3 months ]
Number of patients contacted at 3 months
validity of intervention (medication coach script and patient contacts) [ Time Frame: 3 months ]
The intervention will be evaluated using a survey given to the participants after they have received the intervention (telephone contact post-discharge).
Complete list of historical versions of study NCT01115660 on Archive Site
Follow up Appointment With MD [ Time Frame: 3 months ]
Follow up appointment with primary care provider since stroke
validity of 3-month follow-up questionnaire for collection of medication persistence, resource utilization and functional status. [ Time Frame: 3 months ]
The secondary outcome is validity and refinement of the 3-month follow-up questionnaire for collection of medication persistence, resource utilization and functional status.
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Not Provided
Stroke Education Intervention Trial - Pilot
AVAIL interVention Trial (Adherence Evaluation After Ischemic Stroke - Longitudinal): Pilot Protocol
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.
Not Provided
Not Applicable
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Ischemic Stroke
  • Intracranial Hemorrhage
  • Transient Ischemic Attack
Behavioral: stroke education
call by medication coach 2 weeks after hospital discharge
  • Experimental: 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.
    Intervention: Behavioral: stroke education
  • No Intervention: control arm
    Subjects in this arm received instruction at hospital discharge and a 3-month follow-up call to collect study data.
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2011
June 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
19 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
5U18HS016964 ( U.S. AHRQ Grant/Contract )
Not Provided
Not Provided
Duke University
Duke University
Wake Forest University Health Sciences
Principal Investigator: Eric D Peterson, MD, MPH DCRI
Duke University
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP