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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:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Ischemic Stroke Intracranial Hemorrhage Transient Ischemic Attack Behavioral: stroke education

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: AVAIL interVention Trial (Adherence Evaluation After Ischemic Stroke - Longitudinal): Pilot Protocol
Study Start Date : January 2010
Primary Completion Date : June 2011
Study Completion Date : June 2011
Arms and Interventions

Arm Intervention/treatment
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.
Behavioral: stroke education
call by medication coach 2 weeks after hospital discharge
No Intervention: control arm
Subjects in this arm received instruction at hospital discharge and a 3-month follow-up call to collect study data.


Outcome Measures

Primary Outcome Measures :
  1. Feasibility of Intervention (Ability to Reach Patients at 3 Months) [ Time Frame: 3 months ]
    Number of patients contacted at 3 months


Secondary Outcome Measures :
  1. Follow up Appointment With MD [ Time Frame: 3 months ]
    Follow up appointment with primary care provider since stroke


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01115660


Locations
United States, North Carolina
WFUBMC
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Duke University
Wake Forest University Health Sciences
Investigators
Principal Investigator: Eric D Peterson, MD, MPH DCRI
More Information

Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01115660     History of Changes
Other Study ID Numbers: Pro00019690
5U18HS016964 ( U.S. AHRQ Grant/Contract )
First Posted: May 4, 2010    Key Record Dates
Results First Posted: January 24, 2013
Last Update Posted: October 14, 2015
Last Verified: December 2012

Keywords provided by Duke University:
stroke
patient education
medication adherence

Additional relevant MeSH terms:
Stroke
Ischemia
Hemorrhage
Ischemic Attack, Transient
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Ischemia