Trial Outcomes & Findings for Stroke Ready: A Stroke Preparedness Brief Intervention (NCT NCT03831451)

Last Updated: 2019-12-13

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

129 participants

Primary outcome timeframe

Immediately (up to 10 minutes) before the brief intervention and then immediately (up to 10 minutes) after completing the brief intervention

Results posted on

2019-12-13

Participant Flow

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	74	55
Overall Study COMPLETED	74	55
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Stroke Ready: A Stroke Preparedness Brief Intervention

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stroke Preparedness Intervention n=74 Participants 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	Healthy Lifestyle Intervention n=55 Participants 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	Total n=129 Participants Total of all reporting groups
Age, Continuous	60 years STANDARD_DEVIATION 13 • n=5 Participants	61 years STANDARD_DEVIATION 15 • n=7 Participants	61 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	46 Participants n=5 Participants	33 Participants n=7 Participants	79 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	22 Participants n=7 Participants	50 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	65 Participants n=5 Participants	50 Participants n=7 Participants	115 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Stroke Preparedness Intervention n=74 Participants 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	Healthy Lifestyle Intervention n=55 Participants 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
Change in Behavioral Intent to Call 911	2.1 units on a scale Standard Error 2.7	0.4 units on a scale Standard Error 2.2

Adverse Events

Stroke Preparedness Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthy Lifestyle 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

Dr. Lesli Skolarus

University of Michigan

Phone: 734-936-9075

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place