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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
  Purpose

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 Intervention
Ischemic Stroke
Intracranial Hemorrhage
Transient Ischemic Attack
 Behavioral: stroke education

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: AVAIL interVention Trial (Adherence Evaluation After Ischemic Stroke - Longitudinal): Pilot Protocol

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Follow up Appointment With MD [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Follow up appointment with primary care provider since stroke


Enrollment: 30
Study Start Date: January 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01115660

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

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

Keywords provided by Duke University:
stroke
patient education
medication adherence

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

ClinicalTrials.gov processed this record on June 17, 2013