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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

May 2, 2010
December 14, 2012
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 ] [ Designated as safety issue: No ]
Number of patients contacted at 3 months
validity of intervention (medication coach script and patient contacts) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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 ClinicalTrials.gov Archive Site
Follow up Appointment With MD [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
The secondary outcome is validity and refinement of the 3-month follow-up questionnaire for collection of medication persistence, resource utilization and functional status.
Not Provided
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
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
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
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01115660
Pro00019690, 5U18HS016964
No
Duke University
Duke University
Wake Forest University Baptist Medical Center
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