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Trial record 1 of 2 for:    SCORRE
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Stroke COunseling for Risk REduction (SCORRE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03076125
Recruitment Status : Completed
First Posted : March 10, 2017
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
Dawn Aycock, Georgia State University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: SCORRE Behavioral: Attention-Control Activity Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized controlled two-group pre-post test design
Masking: Double (Participant, Outcomes Assessor)
Masking Description: data collectors conducting post-intervention and 8-week follow up are blinded to participant treatment groups
Primary Purpose: Prevention
Official Title: Stroke Counseling for Risk Reduction in Young Adult African Americans
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : December 20, 2017
Actual Study Completion Date : December 20, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
 Behavioral: SCORRE
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.
 Behavioral: Attention-Control Activity
sexual health education


Outcome Measures
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Primary Outcome Measures :
  1. Accuracy of perceived stroke risk [ Time Frame: immediately post-intervention ]
    Comparison of perceived versus actual stroke risk

  2. Targeted health behaviors [ Time Frame: 8 weeks ]
    Improvements in targeted health behavior (physical activity, diet, or cigarette smoking)


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03076125


Locations
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United States, Georgia
Georgia State University
Atlanta, Georgia, United States, 30294
Sponsors and Collaborators
Georgia State University
More Information
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Responsible Party: Dawn Aycock, Assistant Professor, Georgia State University
ClinicalTrials.gov Identifier: NCT03076125    
Other Study ID Numbers: K01NR015494 ( U.S. NIH Grant/Contract )
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dawn Aycock, Georgia State University:
Primary Stroke Prevention, Risk Factors for Stroke
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases