Stroke Education Intervention Trial - Pilot (AVAIL II)

October 11, 2015 updated by: Duke University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • WFUBMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of Intervention (Ability to Reach Patients at 3 Months)
Time Frame: 3 months
Number of patients contacted at 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Follow up Appointment With MD
Time Frame: 3 months
Follow up appointment with primary care provider since stroke
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Eric D Peterson, MD, MPH, DCRI

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

May 2, 2010

First Submitted That Met QC Criteria

May 2, 2010

First Posted (Estimate)

May 4, 2010

Study Record Updates

Last Update Posted (Estimate)

October 14, 2015

Last Update Submitted That Met QC Criteria

October 11, 2015

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00019690
  • 5U18HS016964 (U.S. AHRQ Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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