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Stroke COunseling for Risk REduction (SCORRE)

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SCORRE
Attention-Control Activity
Sponsored by
Georgia State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke focused on measuring Primary Stroke Prevention, Risk Factors for Stroke

Eligibility Criteria

20 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • self-identify as African American/Black
  • age 20-35 years
  • able to complete two study visits lasing 1 1/2- 2 hours and a brief daily diary for 8 weeks
  • has a cell phone or email address to receive weekly reminders and tips
  • has at least one modifiable risk factor for stroke identified during study visit one screening

Sites / Locations

  • Georgia State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

SCORRE group

Attention Control Group

Arm Description

Stroke risk factor brochure, stroke champions video, counseling on accuracy of perceived stroke risk and strategies to reduce stroke risk, weekly motivational health behavior tips (for physical activity, diet, or smoking cessation) text messages for 8 weeks.

Sexual health education brochure and Safe in the City video, weekly sexual health tips text messages for 8 weeks.

Outcomes

Primary Outcome Measures

Accuracy of perceived stroke risk
Comparison of perceived versus actual stroke risk
Targeted health behaviors
Improvements in targeted health behavior (physical activity, diet, or cigarette smoking)

Secondary Outcome Measures

Full Information

First Posted
March 5, 2017
Last Updated
December 11, 2018
Sponsor
Georgia State University
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1. Study Identification

Unique Protocol Identification Number
NCT03076125
Brief Title
Stroke COunseling for Risk REduction
Acronym
SCORRE
Official Title
Stroke Counseling for Risk Reduction in Young Adult African Americans
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
December 20, 2017 (Actual)
Study Completion Date
December 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Georgia State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to test the efficacy of the Stroke Counseling for Risk Reduction (SCORRE) intervention in increasing accuracy of perceived stroke risk and promoting lifestyle behavior change to reduce stroke risk in young adult African Americans.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Primary Stroke Prevention, Risk Factors for Stroke

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled two-group pre-post test design
Masking
ParticipantOutcomes Assessor
Masking Description
data collectors conducting post-intervention and 8-week follow up are blinded to participant treatment groups
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SCORRE group
Arm Type
Experimental
Arm Description
Stroke risk factor brochure, stroke champions video, counseling on accuracy of perceived stroke risk and strategies to reduce stroke risk, weekly motivational health behavior tips (for physical activity, diet, or smoking cessation) text messages for 8 weeks.
Arm Title
Attention Control Group
Arm Type
Sham Comparator
Arm Description
Sexual health education brochure and Safe in the City video, weekly sexual health tips text messages for 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
SCORRE
Intervention Description
3 components based on the Health Belief Model
Intervention Type
Behavioral
Intervention Name(s)
Attention-Control Activity
Intervention Description
sexual health education
Primary Outcome Measure Information:
Title
Accuracy of perceived stroke risk
Description
Comparison of perceived versus actual stroke risk
Time Frame
immediately post-intervention
Title
Targeted health behaviors
Description
Improvements in targeted health behavior (physical activity, diet, or cigarette smoking)
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: self-identify as African American/Black age 20-35 years able to complete two study visits lasing 1 1/2- 2 hours and a brief daily diary for 8 weeks has a cell phone or email address to receive weekly reminders and tips has at least one modifiable risk factor for stroke identified during study visit one screening
Facility Information:
Facility Name
Georgia State University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30294
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Stroke COunseling for Risk REduction

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