Trial Outcomes & Findings for A Community Partnership to Treat Stroke (NCT NCT01499173)

Results Overview

Number of participants who complete the intervention

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

101 participants

Primary outcome timeframe

1 week

Results posted on

2017-09-29

Participant Flow

Participant milestones

Participant milestones
Measure	Stroke Preparedness Intervention Youth and adults from predominately African American chruches in Flint will be enrolled to undergo a faith-based, scientific theory-driven, peer-led behavioral intervention utilizing a pre-post test design. Stroke Preparedness Intervention: A faith-based, scientific theory-driven, peer-led behavioral intervention performed in a group setting in African American churches.
Overall Study STARTED	101
Overall Study COMPLETED	64
Overall Study NOT COMPLETED	37

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

we present the age of the youth and adults separately

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stroke Preparedness Intervention n=101 Participants Youth and adults from predominately African American chruches in Flint will be enrolled to undergo a faith-based, scientific theory-driven, peer-led behavioral intervention utilizing a pre-post test design. Stroke Preparedness Intervention: A faith-based, scientific theory-driven, peer-led behavioral intervention performed in a group setting in African American churches.
Age, Continuous adults	56 years n=73 Participants • we present the age of the youth and adults separately
Age, Continuous youth	14 years n=28 Participants • we present the age of the youth and adults separately
Sex: Female, Male Female	66 Participants n=101 Participants
Sex: Female, Male Male	35 Participants n=101 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=101 Participants
Race (NIH/OMB) Asian	0 Participants n=101 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=101 Participants
Race (NIH/OMB) Black or African American	101 Participants n=101 Participants
Race (NIH/OMB) White	0 Participants n=101 Participants
Race (NIH/OMB) More than one race	0 Participants n=101 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=101 Participants
Region of Enrollment United States	101 Participants n=101 Participants

PRIMARY outcome

Timeframe: 1 week

Population: descriptive

Number of participants who complete the intervention

Outcome measures

Outcome measures
Measure	Stroke Preparedness Intervention n=101 Participants Youth and adults from predominately African American chruches in Flint will be enrolled to undergo a faith-based, scientific theory-driven, peer-led behavioral intervention utilizing a pre-post test design. Stroke Preparedness Intervention: A faith-based, scientific theory-driven, peer-led behavioral intervention performed in a group setting in African American churches.
Completion	64 Participants

SECONDARY outcome

Timeframe: 1 week elapsed between a pretest before 1st workshop and post-test at the end of 2nd workshop

The pre-test is conducted one week prior to the post-test. A higher score indicates greater behavioral intent. Behavioral intent is measured on a scale of 0 - 8, where 0 indicates no correct answers in responses to scenarios, and 8 indicates appropriate responses (calling 911 every time it is appropriate) to the scenarios presented.

Outcome measures

Outcome measures
Measure	Stroke Preparedness Intervention n=64 Participants Youth and adults from predominately African American chruches in Flint will be enrolled to undergo a faith-based, scientific theory-driven, peer-led behavioral intervention utilizing a pre-post test design. Stroke Preparedness Intervention: A faith-based, scientific theory-driven, peer-led behavioral intervention performed in a group setting in African American churches.
Mean Change in Behavioral Intent to Call 911 post-test	5.2 units on a scale Interval 4.9 to 5.5
Mean Change in Behavioral Intent to Call 911 pre-test	4.4 units on a scale Interval 4.2 to 4.6

SECONDARY outcome

Timeframe: 1 week elapsed between a pretest before 1st workshop and post-test at the end of 2nd workshop

Stroke recognition was scored on a 0 - 9 point scale where 0 represents no correct answers regarding 9 scenarios and 9 represents perfect stroke recognition.

Outcome measures

Outcome measures
Measure	Stroke Preparedness Intervention n=64 Participants Youth and adults from predominately African American chruches in Flint will be enrolled to undergo a faith-based, scientific theory-driven, peer-led behavioral intervention utilizing a pre-post test design. Stroke Preparedness Intervention: A faith-based, scientific theory-driven, peer-led behavioral intervention performed in a group setting in African American churches.
Mean Change in Stroke Recognition pre-test	5.9 units on a scale Interval 5.6 to 6.1
Mean Change in Stroke Recognition post-test	6.0 units on a scale Interval 5.7 to 6.3

SECONDARY outcome

Timeframe: 1 week between pretest before 1st workshop and post-test at the end of 2nd workshop and 1 month till the delayed post test

Perception of social norms is measured by the odds ratio of the responses to questions of participant agreement with others' influence to calling 911 if he/she were to see a stroke. Odds ratios measure the odds of responses, so higher odds ratios suggest greater odds of the positive change in social norms in the post-test compared to the pre-test. Questions: 1) Most people would call 911 if they were to see a stroke. 2) My family would want me to call 911 if I were to see a stroke. Given that participants within each church are more alike than participants between churches and the multiple time points, hierarchical models were used. Specifically, multilevel mixed-effects ordered logistic regression models with a fixed church-level intercept and a random participant level intercept were used to explore change between baseline and immediate post-test and baseline and delayed post-test social norms after accounting for the participants' church.

Outcome measures

Outcome measures
Measure	Stroke Preparedness Intervention n=64 Participants Youth and adults from predominately African American chruches in Flint will be enrolled to undergo a faith-based, scientific theory-driven, peer-led behavioral intervention utilizing a pre-post test design. Stroke Preparedness Intervention: A faith-based, scientific theory-driven, peer-led behavioral intervention performed in a group setting in African American churches.
Perception of Social Norms Clustered Within Churches Across Multiple Time Points 1 wk: Q1: Most people would call 911	-0.5 odds ratio
Perception of Social Norms Clustered Within Churches Across Multiple Time Points 1 wk: Q2: My family would want me to call 911	0.2 odds ratio
Perception of Social Norms Clustered Within Churches Across Multiple Time Points 1 mo: Q1: Most people would call 911	-0.9 odds ratio
Perception of Social Norms Clustered Within Churches Across Multiple Time Points 1 mo: Q2: My family would want me to call 911	0.1 odds ratio

SECONDARY outcome

Timeframe: 1 week between pretest before 1st workshop and post-test at the end of 2nd workshop and 1 month till the delayed post test

Perception of self-efficacy is measured by the odds ratios of the responses to questions of participant confidence in being able to identify and respond appropriately to a stroke. Odds ratios measure the odds of responses, so higher odds ratios suggest greater odds of positive self-efficacy change in the post-test compared to the pretest. Questions asking about self-efficacy were:1) I would be able to tell if someone is having a stroke and 2) I know what to do if I saw someone having a stroke. Given that participants within each church are more alike than participants between churches and multiple time points hierarchical models were used. Specifically, multilevel mixed-effects ordered logistic regression models with a fixed church-level intercept and a random participant level intercept were used to explore change between baseline and immediate post-test and baseline and delayed posttest self-efficacy after accounting for the participants' church.

Outcome measures

Outcome measures
Measure	Stroke Preparedness Intervention n=64 Participants Youth and adults from predominately African American chruches in Flint will be enrolled to undergo a faith-based, scientific theory-driven, peer-led behavioral intervention utilizing a pre-post test design. Stroke Preparedness Intervention: A faith-based, scientific theory-driven, peer-led behavioral intervention performed in a group setting in African American churches.
Perception of Self-efficacy Clustered Within Churches Across Multiple Time Points 1 wk: Q 1: I'd be able to tell	1.2 odds ratio
Perception of Self-efficacy Clustered Within Churches Across Multiple Time Points 1 wk: Q2: I know what to do	.8 odds ratio
Perception of Self-efficacy Clustered Within Churches Across Multiple Time Points 1 mo. Q 1: I'd be able to tell	.8 odds ratio
Perception of Self-efficacy Clustered Within Churches Across Multiple Time Points 1 mo: Q2: I know what to do	.3 odds ratio

SECONDARY outcome

Timeframe: 1 week between pretest before 1st workshop and post-test at the end of 2nd workshop and 1 month till the delayed post test

Stroke attitude is measured by the odds ratio of participant's positive perception of calling 911 for stroke. Odds ratios measure the odds of responses, so higher odds ratios suggest greater odds of stroke attitude change in the post-test compared to pre-test. Stroke attitude questioners were: Q1) If I were to see signs of a stroke, calling 911 would be... (range "extremely pleasant" to "very unpleasant); and Q2) If a person has signs of a stroke, calling 911 right away could be... (range "very helpful" to "very harmful). Given that participants within each church are more alike than participants between churches and multiple time points, hierarchical models were used. Specifically, multilevel mixed-effects ordered logistic regression models with a fixed church-level intercept and a random participant level intercept were used to explore change between baseline and immediate post-test and baseline and delayed post-test stroke attitude after accounting for the participants' church.

Outcome measures

Outcome measures
Measure	Stroke Preparedness Intervention n=64 Participants Youth and adults from predominately African American chruches in Flint will be enrolled to undergo a faith-based, scientific theory-driven, peer-led behavioral intervention utilizing a pre-post test design. Stroke Preparedness Intervention: A faith-based, scientific theory-driven, peer-led behavioral intervention performed in a group setting in African American churches.
Perception of Stroke Attitude Clustered Within Churches Across Multiple Time Points 1 wk: Q1: If I were to see...	.05 Odds ratio
Perception of Stroke Attitude Clustered Within Churches Across Multiple Time Points 1 wk: Q2: If a person has signs of a stroke...	0.3 Odds ratio
Perception of Stroke Attitude Clustered Within Churches Across Multiple Time Points 1 mo: Q1: If I were to see...	-0.07 Odds ratio
Perception of Stroke Attitude Clustered Within Churches Across Multiple Time Points 1 mo: Q2: If a person has signs of a stroke...	-0.5 Odds ratio

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 week elapsed between a pretest before 1st workshop and post-test at the end of 2nd workshop

Program satisfaction is measured by percentage of participants that completed the program who answered on the post test: very satisfied or extremely satisfied on a questionnaire about the program.

Outcome measures

Outcome measures
Measure	Stroke Preparedness Intervention n=64 Participants Youth and adults from predominately African American chruches in Flint will be enrolled to undergo a faith-based, scientific theory-driven, peer-led behavioral intervention utilizing a pre-post test design. Stroke Preparedness Intervention: A faith-based, scientific theory-driven, peer-led behavioral intervention performed in a group setting in African American churches.
Program Satisfaction	80 percentage of participants

Adverse Events

Stroke Preparedness 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, Neurology

Phone: 734-936-9075

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place