StrokeSCORRENCT03076125
Stroke COunseling for Risk REduction
A study testing SCORRE in people with Stroke, run by Georgia State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- SCORRE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2017to 20 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Stroke
- Being tested
- SCORRE, Attention-Control Activity
- Keywords
- Primary Stroke Prevention, Risk Factors for Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCORREBehavioural
3 components based on the Health Belief Model
Attention-Control ActivityBehavioural
sexual health education
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Attention-Control Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of perceived stroke risk
Comparison of perceived versus actual stroke risk
Measured: immediately post-intervention
Targeted health behaviors
Improvements in targeted health behavior (physical activity, diet, or cigarette smoking)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study start1 Mar 2017
- Primary completion20 Dec 2017
- Study completion20 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled two-group pre-post test design
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgia State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dawn Aycock, Georgia State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03076125
- Sponsor's protocol ID
- K01NR015494
- Acronym
- SCORRE
- Status last verified
- Dec 2018
- First submitted
- 5 Mar 2017
- Last updated
- 13 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke Counseling for Risk Reduction in Young Adult African Americans
- ClinicalTrials.gov ID
- NCT03076125
- Acronym / sponsor ID
- SCORRE / K01NR015494
- Conditions
- Stroke
- Keywords
- Primary Stroke Prevention, Risk Factors for Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Georgia State UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 10 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled two-group pre-post test design
| Arm | Type | Receives |
|---|---|---|
| SCORRE group | Experimental | Behavioral: SCORREStroke 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. |
| Attention Control Group | Sham comparator | Behavioral: Attention-Control ActivitySexual health education brochure and Safe in the City video, weekly sexual health tips text messages for 8 weeks. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCORRE3 components based on the Health Belief Model | Behavioural | SCORRE group |
| Attention-Control Activitysexual health education | Behavioural | Attention Control Group |
Primary outcome
Accuracy of perceived stroke risk
Time frame: immediately post-intervention
Comparison of perceived versus actual stroke risk
Targeted health behaviors
Time frame: 8 weeks
Improvements in targeted health behavior (physical activity, diet, or cigarette smoking)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCORRE in people with Stroke, run by Georgia State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of perceived stroke risk (time frame: immediately post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2018.