An interventional study of Stroke preparedness intervention and Healthy lifestyle stroke risk reduction intervention in Stroke, sponsored by University of Michigan. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-13.
Sponsored by University of Michigan · Not applicable, Interventional, and Health services research
This is a randomized controlled behavioral intervention trial to assess the efficacy of a brief intervention to increase stroke preparedness.
This is a randomized controlled behavioral intervention trial to assess the efficacy of a brief intervention to increase stroke preparedness. Subjects will be randomized to a brief face-to-face stroke preparedness intervention compared to a healthy lifestyle stroke risk reduction intervention. The primary outcome is behavioral intent to call 911 using a self-administered survey
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 129 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The stroke preparedness educational intervention was designed with input from the community where it is being tested. It will be delivered in-person by a research team member. The intervention focuses on recognizing stroke symptoms and the importance of calling 911.
Behavioral: Stroke preparedness intervention
The Healthy lifestyle stroke risk reduction educational intervention is based on patient materials from the American Heart Association. It will be delivered in-person by a research team member. The intervention focuses on stroke risk reduction.
Behavioral: Healthy lifestyle stroke risk reduction intervention
Face-to-face interaction with research staff lasting between 5-10 minutes
Face-to-face interaction with research staff lasting between 5-10 minutes
Change in Behavioral Intent to Call 911
Change in Behavioral intent to call 911 using a self-administered survey. The survey is the Stroke Action test which was modified based on community input. Scores range from 0-12 for stroke. A higher score means greater stroke behavioral intent to call 911 for a stroke while a low score means lower behavioral intent to call 911 for a stroke.
Time frame: Immediately (up to 10 minutes) before the brief intervention and then immediately (up to 10 minutes) after completing the brief intervention
| Milestone | Stroke Preparedness Intervention | Healthy Lifestyle Intervention |
|---|---|---|
| Started | 74 | 55 |
| Completed | 74 | 55 |
| Not completed | 0 | 0 |
Change in Behavioral intent to call 911 using a self-administered survey. The survey is the Stroke Action test which was modified based on community input. Scores range from 0-12 for stroke. A higher score means greater stroke behavioral intent to call 911 for a stroke while a low score means lower behavioral intent to call 911 for a stroke.
| units on a scale | Stroke Preparedness Intervention | Healthy Lifestyle Intervention |
|---|---|---|
| Change in Behavioral Intent to Call 911 | 2.1 ± 2.7 | 0.4 ± 2.2 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Stroke Preparedness Intervention | — | — | — |
| Healthy Lifestyle Intervention | — | — | — |
| Age, Continuous(years) | Stroke Preparedness Intervention | Healthy Lifestyle Intervention | Total |
|---|---|---|---|
| Mean | 60 ± 13 | 61 ± 15 | 61 ± 14 |
| Sex: Female, Male(Participants) | Stroke Preparedness Intervention | Healthy Lifestyle Intervention | Total |
|---|---|---|---|
| Female | 46 | 33 | 79 |
| Male | 28 | 22 | 50 |
| Race (NIH/OMB)(Participants) | Stroke Preparedness Intervention | Healthy Lifestyle Intervention | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 65 | 50 | 115 |
| White | 5 | 2 | 7 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 4 | 3 | 7 |
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Plan to share: No
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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University of Michigan