Trial Outcomes & Findings for Prevent Return of Stroke Study (NCT NCT01027273)
NCT ID: NCT01027273
Last Updated: 2014-07-31
Results Overview
Percentage of Participants with Blood Pressure controlled at \<140/90 mm Hg
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
600 participants
Primary outcome timeframe
6 months post enrollment into trial
Results posted on
2014-07-31
Participant Flow
Participants were enrolled from June 2009 to June 2012 recruited at community based sites as well as clinical sites.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
301
|
299
|
|
Overall Study
COMPLETED
|
242
|
266
|
|
Overall Study
NOT COMPLETED
|
59
|
33
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
57
|
31
|
|
Overall Study
Death
|
2
|
2
|
Baseline Characteristics
Prevent Return of Stroke Study
Baseline characteristics by cohort
| Measure |
Peer-Led Stroke Recurrence Prevention Education
n=301 Participants
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.
|
Usual Care (Delayed Intervention)
n=299 Participants
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
n=600 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 11 • n=5 Participants
|
64 years
STANDARD_DEVIATION 11 • n=7 Participants
|
63 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
180 Participants
n=5 Participants
|
177 Participants
n=7 Participants
|
357 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
121 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
243 Participants
n=5 Participants
|
|
Years since stroke
|
1.8 years
STANDARD_DEVIATION 1.4 • n=5 Participants
|
1.8 years
STANDARD_DEVIATION 1.5 • n=7 Participants
|
1.8 years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months post enrollment into trialPercentage of Participants with Blood Pressure controlled at \<140/90 mm Hg
Outcome measures
| Measure |
Peer-Led Stroke Recurrence Prevention Education
n=242 Participants
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.
|
Usual Care (Delayed Intervention)
n=266 Participants
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.
|
|---|---|---|
|
Blood Pressure
|
76 percentage of participants
|
65 percentage of participants
|
PRIMARY outcome
Timeframe: 6 months post enrollment into trialPercentage of participants with controlled Low Density Lipoprotein low (LDL) of less than 100 mg/dL
Outcome measures
| Measure |
Peer-Led Stroke Recurrence Prevention Education
n=242 Participants
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.
|
Usual Care (Delayed Intervention)
n=266 Participants
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.
|
|---|---|---|
|
LDL Cholesterol
|
59 percentage of participants
|
57 percentage of participants
|
PRIMARY outcome
Timeframe: 6 months post enrollment into trialNumber of participants taking anti-thrombotic medication
Outcome measures
| Measure |
Peer-Led Stroke Recurrence Prevention Education
n=242 Participants
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.
|
Usual Care (Delayed Intervention)
n=266 Participants
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.
|
|---|---|---|
|
Use of Anti-thrombotic Medication
|
199 participants
|
226 participants
|
SECONDARY outcome
Timeframe: 6 months post enrollment into trialOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 months post enrollment into trialNumber 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.
Outcome measures
| Measure |
Peer-Led Stroke Recurrence Prevention Education
n=242 Participants
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.
|
Usual Care (Delayed Intervention)
n=266 Participants
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.
|
|---|---|---|
|
Medication Adherence
|
159 participants
|
169 participants
|
SECONDARY outcome
Timeframe: 6 months post enrollment into trialNumber 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.
Outcome measures
| Measure |
Peer-Led Stroke Recurrence Prevention Education
n=242 Participants
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.
|
Usual Care (Delayed Intervention)
n=266 Participants
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.
|
|---|---|---|
|
Emotional Health
|
46 participants
|
59 participants
|
SECONDARY outcome
Timeframe: 6 months post enrollment into trialPopulation: 1 missing response from Usual Care group
Number of participants who have a primary care doctor
Outcome measures
| Measure |
Peer-Led Stroke Recurrence Prevention Education
n=242 Participants
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.
|
Usual Care (Delayed Intervention)
n=265 Participants
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.
|
|---|---|---|
|
Access to Medical Care
|
232 participants
|
240 participants
|
Adverse Events
Peer-Led Stroke Recurrence Prevention Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care (Delayed Intervention)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Carol R Horowitz, MD, MPH
Icahn School of Medicine at Mount Sinai
Phone: 212-659-9567
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place