Stroke
Conditions
Keywords
stroke preparedness, behavioral intervention
Brief summary
This is a randomized controlled behavioral intervention trial to assess the efficacy of a brief intervention to increase stroke preparedness.
Detailed description
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
Interventions
BEHAVIORALStroke preparedness intervention
Face-to-face interaction with research staff lasting between 5-10 minutes
BEHAVIORALHealthy lifestyle stroke risk reduction intervention
Face-to-face interaction with research staff lasting between 5-10 minutes
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* over 18 years of age
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Behavioral Intent to Call 911 | Immediately (up to 10 minutes) before the brief intervention and then immediately (up to 10 minutes) after completing the brief intervention | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 74 |
| 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 | 55 |
| Total | 129 |
Baseline characteristics
| Characteristic | Healthy Lifestyle Intervention | Total | Stroke Preparedness Intervention |
|---|---|---|---|
| Age, Continuous | 61 years STANDARD_DEVIATION 15 | 61 years STANDARD_DEVIATION 14 | 60 years STANDARD_DEVIATION 13 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 50 Participants | 115 Participants | 65 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) White | 2 Participants | 7 Participants | 5 Participants |
| Sex: Female, Male Female | 33 Participants | 79 Participants | 46 Participants |
| Sex: Female, Male Male | 22 Participants | 50 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: Immediately (up to 10 minutes) before the brief intervention and then immediately (up to 10 minutes) after completing the brief intervention
Population: Mean changes from pre-intervention to post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stroke Preparedness Intervention | Change in Behavioral Intent to Call 911 | 2.1 units on a scale | Standard Error 2.7 |
| Healthy Lifestyle Intervention | Change in Behavioral Intent to Call 911 | 0.4 units on a scale | Standard Error 2.2 |