- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03076125
Stroke COunseling for Risk REduction (SCORRE)
December 11, 2018 updated by: Dawn Aycock, Georgia State University
Stroke Counseling for Risk Reduction in Young Adult African Americans
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
116
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30294
- Georgia State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 35 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: SCORRE group
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.
|
3 components based on the Health Belief Model
|
|
SHAM_COMPARATOR: Attention Control Group
Sexual health education brochure and Safe in the City video, weekly sexual health tips text messages for 8 weeks.
|
sexual health education
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accuracy of perceived stroke risk
Time Frame: immediately post-intervention
|
Comparison of perceived versus actual stroke risk
|
immediately post-intervention
|
|
Targeted health behaviors
Time Frame: 8 weeks
|
Improvements in targeted health behavior (physical activity, diet, or cigarette smoking)
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 1, 2017
Primary Completion (ACTUAL)
December 20, 2017
Study Completion (ACTUAL)
December 20, 2017
Study Registration Dates
First Submitted
March 5, 2017
First Submitted That Met QC Criteria
March 5, 2017
First Posted (ACTUAL)
March 10, 2017
Study Record Updates
Last Update Posted (ACTUAL)
December 13, 2018
Last Update Submitted That Met QC Criteria
December 11, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- K01NR015494 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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