Prevent Return of Stroke Study

• Sponsor: Icahn School of Medicine at Mount Sinai (Other)
• Overall Status: Completed
• CT.gov ID: NCT01027273
• Collaborator: National Institute on Minority Health and Health Disparities (NIMHD) (NIH), North General Hospital, New York (Other), Stanford University (Other)
• Enrollment: 600
• Location: 1
• Arms: 2
• Duration (Months): 44.1
• Patients Per Site Per Month: 13.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Recurrence; Transient Ischemic Attack	Behavioral: Prevent Return of Stroke; Behavioral: Prevent Return of Stroke	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 600 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Preventing Recurrence of All Inner-city Strokes Through Education
• Study Start Date: Jun 1, 2009
• Actual Primary Completion Date: Feb 1, 2013
• Actual Study Completion Date: Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Peer-Led Stroke Recurrence Prevention Education The intervention group will participate in a 6-session course held over a 6-week period. The Prevent Return of Stroke Workshop, led by trained peer educators, aims to help participants control the risk factors for stroke, thereby preventing recurrence of strokes.	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.
Placebo Comparator: Usual Care (Delayed Intervention) The control group will be offered the chance to take part in the 6-week session intervention after 12 months after enrollment into the trial.	Behavioral: 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.

Outcome Measures

Primary Outcome Measures

1. Blood Pressure [6 months post enrollment into trial]

   Percentage of Participants with Blood Pressure controlled at <140/90 mm Hg

2. LDL Cholesterol [6 months post enrollment into trial]

   Percentage of participants with controlled Low Density Lipoprotein low (LDL) of less than 100 mg/dL

3. Use of Anti-thrombotic Medication [6 months post enrollment into trial]

   Number of participants taking anti-thrombotic medication

Secondary Outcome Measures

1. Knowledge and Attitudes About Stroke Recurrence Risk [6 months post enrollment into trial]

2. 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.

3. 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.

4. Access to Medical Care [6 months post enrollment into trial]

   Number of participants who have a primary care doctor

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Carol R Horowitz, MD, MPH, Icahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.

• Responsible Party: Icahn School of Medicine at Mount Sinai
• ClinicalTrials.gov Identifier: NCT01027273
• Other Study ID Numbers: GCO 02-0515 Project 1; 5P60MD000270-08
• First Posted: Dec 7, 2009
• Last Update Posted: Jul 31, 2014
• Last Verified: Jul 1, 2014

• Keywords provided by Icahn School of Medicine at Mount Sinai: 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
• Additional relevant MeSH terms: Stroke; Ischemic Attack, Transient; Recurrence

Study Results

Participant Flow

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

Arm/Group Title	Peer-Led Stroke Recurrence Prevention Education	Usual Care (Delayed Intervention)
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	301	299
COMPLETED	242	266
NOT COMPLETED	59	33

Baseline Characteristics

Arm/Group Title	Peer-Led Stroke Recurrence Prevention Education	Usual Care (Delayed Intervention)	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	301	299	600
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63 (11)	64 (11)	63 (11)
Sex: Female, Male (Count of Participants)
Female	180 59.8%	177 59.2%	357 59.5%
Male	121 40.2%	122 40.8%	243 40.5%
Years since stroke (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	1.8 (1.4)	1.8 (1.5)	1.8 (1.5)

Outcome Measures

1. Primary Outcome

Title	Blood Pressure
Description	Percentage of Participants with Blood Pressure controlled at <140/90 mm Hg
Time Frame	6 months post enrollment into trial

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Peer-Led Stroke Recurrence Prevention Education	Usual Care (Delayed Intervention)
Arm/Group Description	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.	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.
Measure Participants	242	266
Number [percentage of participants]	76 25.2%	65 21.7%

2. Primary Outcome

Title	LDL Cholesterol
Description	Percentage of participants with controlled Low Density Lipoprotein low (LDL) of less than 100 mg/dL
Time Frame	6 months post enrollment into trial

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Peer-Led Stroke Recurrence Prevention Education	Usual Care (Delayed Intervention)
Arm/Group Description	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.	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.
Measure Participants	242	266
Number [percentage of participants]	59 19.6%	57 19.1%

3. Primary Outcome

Title	Use of Anti-thrombotic Medication
Description	Number of participants taking anti-thrombotic medication
Time Frame	6 months post enrollment into trial

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Peer-Led Stroke Recurrence Prevention Education	Usual Care (Delayed Intervention)
Arm/Group Description	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.	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.
Measure Participants	242	266
Number [participants]	199 66.1%	226 75.6%

4. Secondary Outcome

Title	Knowledge and Attitudes About Stroke Recurrence Risk
Time Frame	6 months post enrollment into trial

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Medication Adherence
Description	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.
Time Frame	6 months post enrollment into trial

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Peer-Led Stroke Recurrence Prevention Education	Usual Care (Delayed Intervention)
Arm/Group Description	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.	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.
Measure Participants	242	266
Number [participants]	159 52.8%	169 56.5%

6. Secondary Outcome

Title	Emotional Health
Description	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.
Time Frame	6 months post enrollment into trial

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Peer-Led Stroke Recurrence Prevention Education	Usual Care (Delayed Intervention)
Arm/Group Description	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.	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.
Measure Participants	242	266
Number [participants]	46 15.3%	59 19.7%

7. Secondary Outcome

Title	Access to Medical Care
Description	Number of participants who have a primary care doctor
Time Frame	6 months post enrollment into trial

Outcome Measure Data

Analysis Population Description

1 missing response from Usual Care group

Arm/Group Title	Peer-Led Stroke Recurrence Prevention Education	Usual Care (Delayed Intervention)
Arm/Group Description	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.	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.
Measure Participants	242	265
Number [participants]	232 77.1%	240 80.3%

Adverse Events

Arm/Group Title	Peer-Led Stroke Recurrence Prevention Education		Usual Care (Delayed Intervention)
Arm/Group Description	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.		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.
All Cause Mortality
	Peer-Led Stroke Recurrence Prevention Education		Usual Care (Delayed Intervention)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Peer-Led Stroke Recurrence Prevention Education		Usual Care (Delayed Intervention)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/301 (0%)		0/299 (0%)
Other (Not Including Serious) Adverse Events
	Peer-Led Stroke Recurrence Prevention Education		Usual Care (Delayed Intervention)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/301 (0%)		0/299 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.