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| ID | Type | Description | Link |
|---|---|---|---|
| U01MD010579 | U.S. NIH Grant/Contract | View source |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stroke Preparedness Intervention | Experimental | 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. |
|
| Healthy lifestyle intervention | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stroke preparedness intervention | Behavioral | Face-to-face interaction with research staff lasting between 5-10 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately (up to 10 minutes) before the brief intervention and then immediately (up to 10 minutes) after completing the brief intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lesli Skolarus, MD, MS | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton Community Health Network | Flint | Michigan | 48505 | United States | ||
| Hasselbring Senior Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33238728 | Derived | Robles MC, Springer MV, Corches CL, Burke JF, Lin CC, Oliver A, Skolarus LE. Stroke Ready Very Brief Intervention Improves Immediate Postintervention Stroke Preparedness. Circ Cardiovasc Qual Outcomes. 2020 Dec;13(12):e006643. doi: 10.1161/CIRCOUTCOMES.120.006643. Epub 2020 Nov 26. No abstract available. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stroke Preparedness Intervention | 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. Stroke preparedness intervention: Face-to-face interaction with research staff lasting between 5-10 minutes |
| FG001 | Healthy Lifestyle 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. Healthy lifestyle stroke risk reduction intervention: Face-to-face interaction with research staff lasting between 5-10 minutes |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Stroke Preparedness Intervention | 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. Stroke preparedness intervention: Face-to-face interaction with research staff lasting between 5-10 minutes |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Mean changes from pre-intervention to post-intervention | Posted | Mean | Standard Error | units on a scale | Immediately (up to 10 minutes) before the brief intervention and then immediately (up to 10 minutes) after completing the brief intervention |
|
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Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stroke Preparedness Intervention | 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. Stroke preparedness intervention: Face-to-face interaction with research staff lasting between 5-10 minutes |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lesli Skolarus | University of Michigan | 734-936-9075 | lerusche@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 10, 2019 | Nov 1, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 10, 2019 | Nov 1, 2019 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Subjects will be randomized to a brief face-to-face stroke preparedness intervention compared to a healthy lifestyle stroke risk reduction intervention. After completing the outcome assessment, subjects will have the opportunity to receive the intervention that they were not initially randomized too.
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| Healthy lifestyle stroke risk reduction intervention | Behavioral | Face-to-face interaction with research staff lasting between 5-10 minutes |
|
| Flint |
| Michigan |
| 48505 |
| United States |
| BG001 | Healthy Lifestyle 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. Healthy lifestyle stroke risk reduction intervention: Face-to-face interaction with research staff lasting between 5-10 minutes |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Healthy Lifestyle 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. Healthy lifestyle stroke risk reduction intervention: Face-to-face interaction with research staff lasting between 5-10 minutes |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Healthy Lifestyle 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. Healthy lifestyle stroke risk reduction intervention: Face-to-face interaction with research staff lasting between 5-10 minutes | 0 | 0 | 0 | 0 | 0 | 0 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |