Stroke RecurrenceNCT01027273
Prevent Return of Stroke Study
A study testing Prevent Return of Stroke in people with Stroke Recurrence and Transient Ischemic Attack, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Stroke Recurrence, Transient Ischemic Attack
- What is being tested?
- Prevent Return of Stroke
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Feb 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Pregnant
- Nursing home resident
- Prisoner
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Preventing Recurrence of All Inner-city Strokes Through Education
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.
Read the 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:
- 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;
- 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
- 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.
- Conditions
- Stroke Recurrence, Transient Ischemic Attack
- Being tested
- Prevent Return of Stroke
- 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
- Medical subject headings
- Ischemic Attack, Transient, Stroke, Ischemic Stroke, Cerebrovascular Disorders, Brain Ischemia, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevent Return of StrokeBehavioural
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 StrokeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Peer-Led Stroke Recurrence Prevention Education | Experimental | 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. Receives: Behavioral: Prevent Return of Stroke |
| Usual Care (Delayed Intervention) | Placebo comparator | 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. Receives: Behavioral: Prevent Return of Stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Percentage of Participants with Blood Pressure controlled at <140/90 mm Hg
Measured: 6 months post enrollment into trial
LDL Cholesterol
Percentage of participants with controlled Low Density Lipoprotein low (LDL) of less than 100 mg/dL
Measured: 6 months post enrollment into trial
Use of Anti-thrombotic Medication
Number of participants taking anti-thrombotic medication
Measured: 6 months post enrollment into trial
Secondary outcomes (4)
Knowledge and Attitudes About Stroke Recurrence Risk
Measured: 6 months post enrollment into trial
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.
Measured: 6 months post enrollment into trial
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.
Measured: 6 months post enrollment into trial
Access to Medical Care
Number of participants who have a primary care doctor
Measured: 6 months post enrollment into trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2009 (estimated)
- Study startJun 2009
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Stroke RecurrenceStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), North General Hospital, New York, Stanford University
- Responsible party
- Sponsor
- Investigators
- Carol R Horowitz, MD, MPH, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01027273
- Sponsor's protocol ID
- GCO 02-0515 Project 1
- Other IDs
- 5P60MD000270-08
- Status last verified
- Jul 2014
- First submitted
- 4 Dec 2009
- Last updated
- 31 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 22710563Kronish 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.
PubMed 22618380Kronish 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.
PubMed 23288379Edmondson 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.
PubMed 23294320Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
PubMed 34813082Kronish IM, Goldfinger JZ, Negron R, Fei K, Tuhrim S, Arniella G, Horowitz CR. Effect of peer education on stroke prevention: the prevent recurrence of all inner-city strokes through education randomized controlled trial. Stroke. 2014 Nov;45(11):3330-6. doi: 10.1161/STROKEAHA.114.006623. Epub 2014 Sep 23.
PubMed 25248910
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Recurrence of All Inner-city Strokes Through Education
- ClinicalTrials.gov ID
- NCT01027273
- Acronym / sponsor ID
- GCO 02-0515 Project 1
- Conditions
- Stroke Recurrence, Transient Ischemic Attack
- Keywords
- Stroke, Ischemic Stroke, Transient Ischemic Attack, Stroke Recurrence Prevention, Cerebrovascular Disorders, Brain Ischemia, Brain Infraction, Brain Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), North General Hospital, New York, Stanford University
- Study start
- Jun 2009
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 7 Dec 2009 (estimated)
- Results
- Posted 21 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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;
- 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
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer-Led Stroke Recurrence Prevention Education | Experimental | Behavioral: Prevent Return of StrokeThe 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. |
| Usual Care (Delayed Intervention) | Placebo comparator | Behavioral: Prevent Return of StrokeThe control group will be offered the chance to take part in the 6-week session intervention after 12 months after enrollment into the trial. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prevent Return of StrokePrevent 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. | Behavioural | Peer-Led Stroke Recurrence Prevention Education |
| Prevent Return of StrokeThe 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. | Behavioural | Usual Care (Delayed Intervention) |
Primary outcome
Blood Pressure
Time frame: 6 months post enrollment into trial
Percentage of Participants with Blood Pressure controlled at <140/90 mm Hg
LDL Cholesterol
Time frame: 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
Time frame: 6 months post enrollment into trial
Number of participants taking anti-thrombotic medication
4 secondary outcomes
Knowledge and Attitudes About Stroke Recurrence Risk
Time frame: 6 months post enrollment into trial
Medication Adherence
Time frame: 6 months post enrollment into trial
Emotional Health
Time frame: 6 months post enrollment into trial
Access to Medical Care
Time frame: 6 months post enrollment into trial
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22710563Goldfinger 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.
- Background: PubMed 22618380Kronish 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.
- Background: PubMed 23288379Kronish 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.
- Background: PubMed 23294320Edmondson 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.
- Derived from this study: PubMed 34813082Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
- Derived from this study: PubMed 25248910Kronish IM, Goldfinger JZ, Negron R, Fei K, Tuhrim S, Arniella G, Horowitz CR. Effect of peer education on stroke prevention: the prevent recurrence of all inner-city strokes through education randomized controlled trial. Stroke. 2014 Nov;45(11):3330-6. doi: 10.1161/STROKEAHA.114.006623. Epub 2014 Sep 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carol R Horowitz, MD, MPH principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prevent Return of Stroke in people with Stroke Recurrence and Transient Ischemic Attack, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (time frame: 6 months post enrollment into trial). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01027273, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2014; AzTrials last refreshed its copy on 27 Oct 2026.