Stroke Education Intervention Trial - Pilot

Ischemic Stroke Clinical Trial

— AVAIL II  

Official title:

AVAIL interVention Trial (Adherence Evaluation After Ischemic Stroke - Longitudinal): Pilot Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01115660
• Other study ID #: Pro00019690
• Secondary ID: 5U18HS016964
• Status: Completed
• Phase: N/A
• First received: May 2, 2010
• Last updated: October 11, 2015
• Start date: January 2010
• Est. completion date: June 2011

Study information

• Verified date: December 2012
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Intracranial Hemorrhage
• Intracranial Hemorrhages
• Ischemia
• Ischemic Attack, Transient
• Ischemic Stroke
• Stroke
• Transient Ischemic Attack

Intervention

Behavioral:
• stroke education
call by medication coach 2 weeks after hospital discharge

Locations

Country	Name	City	State
United States	WFUBMC	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Wake Forest Baptist Health

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of Intervention (Ability to Reach Patients at 3 Months)	Number of patients contacted at 3 months	3 months	No
Secondary	Follow up Appointment With MD	Follow up appointment with primary care provider since stroke	3 months	No