Prevent Return of Stroke Study

Transient Ischemic Attack Clinical Trial

Official title:

Preventing Recurrence of All Inner-city Strokes Through Education

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01027273
• Other study ID #: GCO 02-0515 Project 1
• Secondary ID: 5P60MD000270-08
• Status: Completed
• Phase: N/A
• First received: December 4, 2009
• Last updated: July 24, 2014
• Start date: June 2009
• Est. completion date: February 2013

Study information

• Verified date: July 2014
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate if a peer-led stroke recurrence prevention intervention, versus usual care, will help reduce risk factors for recurrent strokes among adults in Harlem.

Description:

Twenty nine percent of the 700,000 strokes that occur yearly nationwide are among stroke survivors. Blacks, both nationally and among Harlem residents, have a twofold increase in recurrent strokes. Harlem Latinos have a threefold increase in risk relative to Whites.

Primary risk factors for recurrent stroke include hypertension, hyperlipidemia, and under use of anti-thrombotic agents. Controlling risk factors can be particularly challenging for low-income, minority populations who lack the resources needed to adhere to necessary therapies. In Harlem, 72% of adults studied six months post stroke did not have these three risk factors treated adequately.

We propose to determine if participation in a recurrent stroke prevention educational intervention, versus usual care, can activated stroke survivors to at reduce primary risk factors for recurrent strokes while providing an effective, low-cost, sustainable recurrent stroke prevention program in neighborhoods like Harlem, whose residents bear a disproportionate burden of suffering from strokes. Specifically, we propose:

1. Recruit 600 adults who sustained a stroke or transient ischemic attack (TIA) within the past five years by working with Harlem community leaders, local clinical sites including the Mount Sinai Medical Center and the Institute for Family Health, and the Visiting Nurse Service of New York;

2. To conduct a randomized, controlled trial to determine if participation in a peer-led stroke prevention program activates stroke and TIA survivors to improve their knowledge and self-management strategies and treatments related to stroke prevention; and

3. To rigorously compare the impact of the intervention with usual care (delayed intervention), on increasing the proportion of individuals with strokes and TIAs who are appropriately treated to reduce the risk of recurrent events, specifically through control of hypertension (blood pressure ≤ 140/90mmHg), hyperlipidemia (LDL cholesterol≤100 mg/dl) and use of anti-thrombotic medicines.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Had a stroke or TIA diagnosed within 5 years

• 40 years of age or older

• Able to participate in group education classes

• English or Spanish speaking

• Community dwelling

Exclusion Criteria:

• No incidence of stroke or TIA

• Stroke or TIA occurred more than 5 years ago

• less than 40 years of age

• Cognitive or physical impairment that would preclude comprehension of a conversation and communicating as part of a group (i.e., dementia, deafness, inability to speak, aphasia)

• Self-reported terminal illness with life expectancy of less than 1 year

• Plans to relocate from New York City within one year of enrollment

• Pregnant

• Nursing home resident

• Prisoner

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Ischemic Attack, Transient
• Recurrence
• Stroke
• Stroke Recurrence
• Transient Ischemic Attack

Intervention

Behavioral:
• Prevent Return of Stroke
Prevent Return of Stroke is a community-based, peer-led stroke recurrence prevention program. This is a bilingual (English/Spanish) education program written at a 4th grade reading level, and contains simple, actionable, messages, easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes, to help reduce stroke recurrence risk factors. It consists of 6 sessions (1½ hours each) held over 6-weeks. Topics include learning the risk factors for stroke, controlling hypertension, LDL cholesterol, preventing blood clots, medication adherence, and stress management.The intervention arm will participate in the intervention shortly after enrolling in the trial.
• Prevent Return of Stroke
The intervention arm will participate in the intervention shortly after enrolling in the trial. The usual care arm will be offered the intervention after 12 months from enrolling in the trial.

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Institute on Minority Health and Health Disparities (NIMHD), North General Hospital, New York, Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (4)

Edmondson D, Horowitz CR, Goldfinger JZ, Fei K, Kronish IM. Concerns about medications mediate the association of posttraumatic stress disorder with adherence to medication in stroke survivors. Br J Health Psychol. 2013 Nov;18(4):799-813. doi: 10.1111/bjhp.12022. Epub 2013 Jan 7. — View Citation

Goldfinger JZ, Kronish IM, Fei K, Graciani A, Rosenfeld P, Lorig K, Horowitz CR. Peer education for secondary stroke prevention in inner-city minorities: design and methods of the prevent recurrence of all inner-city strokes through education randomized controlled trial. Contemp Clin Trials. 2012 Sep;33(5):1065-73. doi: 10.1016/j.cct.2012.06.003. Epub 2012 Jun 15. — View Citation

Kronish IM, Diefenbach MA, Edmondson DE, Phillips LA, Fei K, Horowitz CR. Key barriers to medication adherence in survivors of strokes and transient ischemic attacks. J Gen Intern Med. 2013 May;28(5):675-82. doi: 10.1007/s11606-012-2308-x. Epub 2013 Jan 4. — View Citation

Kronish IM, Edmondson D, Goldfinger JZ, Fei K, Horowitz CR. Posttraumatic stress disorder and adherence to medications in survivors of strokes and transient ischemic attacks. Stroke. 2012 Aug;43(8):2192-7. doi: 10.1161/STROKEAHA.112.655209. Epub 2012 May 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure	Percentage of Participants with Blood Pressure controlled at <140/90 mm Hg	6 months post enrollment into trial	No
Primary	LDL Cholesterol	Percentage of participants with controlled Low Density Lipoprotein low (LDL) of less than 100 mg/dL	6 months post enrollment into trial	No
Primary	Use of Anti-thrombotic Medication	Number of participants taking anti-thrombotic medication	6 months post enrollment into trial	No
Secondary	Knowledge and Attitudes About Stroke Recurrence Risk		6 months post enrollment into trial	No
Secondary	Medication Adherence	Number of participants adherent to medications as determined with Morisky score = 6 Adherence to medications was measured using the 8-item Morisky Medication Adherence Questionnaire (Morisky). The questionnaire has been validated against an objective measure of adherence and has been used in racially diverse and elderly patient samples. Scores on the questionnaire can be used to classify patients into low and high adherence groups.; Consistent with standard cut points, participants who scored less than 6 points on the Morisky were categorized as nonadherent to medications and participants who scored 6 to 8 points were categorized as adherent.	6 months post enrollment into trial	No
Secondary	Emotional Health	Number of participants diagnosed as depressed utilizing depression scale. Participant is determined to be depressed if Patient Health Questionnaire (PHQ8) = 10. Scale has a total score between 0 and 24 points. A total score of 0 to 4 represents no significant depressive symptoms. A total score of 5 to 9 represents mild depressive symptoms; 10 to 14, moderate; 15 to 19, moderately severe; and 20 to 24, severe.	6 months post enrollment into trial	No
Secondary	Access to Medical Care	Number of participants who have a primary care doctor	6 months post enrollment into trial	No