Stroke Education Intervention Trial - Pilot

NCT01115660 | Completed Results

• 2 other identifiers: Pro000196905U18HS016964
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke; Intracranial Hemorrhage; Transient Ischemic Attack

Keywords

stroke; patient education; medication adherence

Outcome Measures

Primary Outcomes (1)

• Feasibility of Intervention (Ability to Reach Patients at 3 Months)

  Number of patients contacted at 3 months

  3 months

Secondary Outcomes (1)

• Follow up Appointment With MD

  3 months

Study Arms (2)

stroke education

EXPERIMENTAL

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

control arm

NO INTERVENTION

Subjects in this arm received instruction at hospital discharge and a 3-month follow-up call to collect study data.

Interventions

stroke education BEHAVIORAL

call by medication coach 2 weeks after hospital discharge

stroke education

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• Wake Forest University Health Sciences: collaborator

Study Sites (1)

WFUBMC

Winston-Salem, North Carolina, 27157, United States

Location

Related 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.

  PMID: 22830539 RESULT

MeSH Terms

Conditions

Ischemic Stroke; Intracranial Hemorrhages; Ischemic Attack, Transient; Stroke; Medication Adherence

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Ischemia; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Limitations and Caveats

Adverse events not collected

Results Point of Contact

• Title: Dr. Cheryl Bushnell
• Organization: Wake Forest School of Medicine

cbushnel@wakehealth.edu

(336) 716-2357

Study Officials

• Eric D Peterson, MD, MPH

  DCRI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2010
• First Posted: May 4, 2010
• Study Start: January 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: October 14, 2015
• Results First Posted: January 24, 2013

Record last verified: 2012-12

Locations

US (1)