Prevent Return of Stroke Study

Preventing Recurrence of All Inner-city Strokes Through Education

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01027273

Enrollment

600

Registered

2009-12-07

Start date

2009-06-30

Completion date

2013-02-28

Last updated

2014-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke Recurrence, Transient Ischemic Attack

Keywords

Stroke, Ischemic Stroke, Transient Ischemic Attack, Stroke Recurrence Prevention, Cerebrovascular Disorders, Brain Ischemia, Brain Infraction, Brain Diseases, Cerebral Infraction, Self-management, Peer-led, Community Based

Brief 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.

Detailed 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.

Interventions

BEHAVIORALPrevent 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Blood Pressure	6 months post enrollment into trial	Percentage of Participants with Blood Pressure controlled at \<140/90 mm Hg
LDL Cholesterol	6 months post enrollment into trial	Percentage of participants with controlled Low Density Lipoprotein low (LDL) of less than 100 mg/dL
Use of Anti-thrombotic Medication	6 months post enrollment into trial	Number of participants taking anti-thrombotic medication

Secondary

Measure	Time frame	Description
Knowledge and Attitudes About Stroke Recurrence Risk	6 months post enrollment into trial	—
Access to Medical Care	6 months post enrollment into trial	Number of participants who have a primary care doctor
Medication Adherence	6 months post enrollment into trial	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.
Emotional Health	6 months post enrollment into trial	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.

Countries

United States

Participant flow

Recruitment details

Participants were enrolled from June 2009 to June 2012 recruited at community based sites as well as clinical sites.

Participants by arm

Arm	Count
Peer-Led Stroke Recurrence Prevention Education The intervention group participated in a 6-session course held over a 6-week period. The Prevent Return of Stroke Workshop, led by trained peer educators, aimed to help participants control the risk factors for stroke, thereby preventing recurrence of strokes. 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.	301
Usual Care (Delayed Intervention) The control group was offered the chance to take part in the 6-week session intervention after 12 months after enrollment into the trial. Prevent Return of Stroke: The intervention arm participated in the intervention shortly after enrolling in the trial. The usual care arm was offered the intervention after 12 months from enrolling in the trial.	299
Total	600

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Death	2	2
Overall Study	Lost to Follow-up	57	31

Baseline characteristics

Characteristic	Peer-Led Stroke Recurrence Prevention Education	Usual Care (Delayed Intervention)	Total
Age, Continuous	63 years STANDARD_DEVIATION 11	64 years STANDARD_DEVIATION 11	63 years STANDARD_DEVIATION 11
Sex: Female, Male Female	180 Participants	177 Participants	357 Participants
Sex: Female, Male Male	121 Participants	122 Participants	243 Participants
Years since stroke	1.8 years STANDARD_DEVIATION 1.4	1.8 years STANDARD_DEVIATION 1.5	1.8 years STANDARD_DEVIATION 1.5

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 301	0 / 299
serious Total, serious adverse events	0 / 301	0 / 299