Stroke COunseling for Risk REduction

NCT03076125 | Completed

• 1 other identifier: K01NR015494
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Primary Stroke Prevention, Risk Factors for Stroke

Outcome Measures

Primary Outcomes (2)

• Accuracy of perceived stroke risk

  Comparison of perceived versus actual stroke risk

  immediately post-intervention

• Targeted health behaviors

  Improvements in targeted health behavior (physical activity, diet, or cigarette smoking)

  8 weeks

Study Arms (2)

SCORRE group

EXPERIMENTAL

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

Attention Control Group

SHAM COMPARATOR

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

Behavioral: Attention-Control Activity

Interventions

SCORRE BEHAVIORAL

3 components based on the Health Belief Model

SCORRE group

Attention-Control Activity BEHAVIORAL

sexual health education

Attention Control Group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Georgia State University: lead

Study Sites (1)

Georgia State University

Atlanta, Georgia, 30294, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: data collectors conducting post-intervention and 8-week follow up are blinded to participant treatment groups
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: randomized controlled two-group pre-post test design

Study Record Dates

• First Submitted: March 5, 2017
• First Posted: March 10, 2017
• Study Start: March 1, 2017
• Primary Completion: December 20, 2017
• Study Completion: December 20, 2017
• Last Updated: December 13, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)