Ischemic StrokeNCT01071408
Trial of a Secondary Stroke Prevention Program
A study testing Stroke prevention care program in people with Ischemic Stroke and Transient Ischemic Attack, run by Sepulveda Research Corporation at 1 site in United States.
Trial summary
The purpose of this study is to determine whether an outpatient program can reduce the risk of recurrent stroke. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ischemic Stroke, Transient Ischemic Attack
- What is being tested?
- Stroke prevention care program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to May 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ischemic stroke within the past 30 days
- transient ischemic attack within the past 30 days
- person receiving care at VA Long Beach Healthcare System
Who cannot join
- unable to understand informed consent
- already enrolled in another research study
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Long Beach Health Care System
Long Beach, California, 90822
About this study
Official title: Development of a Stroke Prevention Program for an Underserved Minority Community
The purpose of this study is to determine whether an outpatient program can reduce the risk of recurrent stroke.
Read the detailed description
Stroke is a major cause of death and disability. A history of stroke is the strongest predictor of a future stroke. Control of risk factors lowers the risk of future stroke, yet most persons with stroke do not have their risk factors controlled.
In this randomized-controlled trial, we will test whether an outpatient stroke prevention program consisting of group clinics, patient self-management, and telephone care coordination can lower the risk of recurrent stroke by improving patient knowledge, medication adherence, and lifestyle habits. If successful, this program may be adapted to other settings.
- Conditions
- Ischemic Stroke, Transient Ischemic Attack
- Being tested
- Stroke prevention care program
- Keywords
- chronic care model, stroke prevention, health services research
- Medical subject headings
- Ischemic Stroke, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stroke prevention care programOther
Also called group clinics, chronic care model, secondary stroke prevention program, nurse practitioner
Stroke prevention care program consists of group clinics, telephone coordination of care, and tracking of care through registries in the first 7 months after stroke or TIA presentation. A nurse practitioner will follow algorithms to adjust medications and to motivate patients to improve lifestyle habits.
| Study group | Role | What they receive |
|---|---|---|
| Stroke Prevention Program + Usual Care | Experimental | Stroke Prevention Care Program + Usual Care. The Stroke prevention care program is in addition, not a substitute for usual care. Persons randomized to this arm are eligible to all care, including care by stroke specialists, while enrolled in the intervention. Receives: Other: Stroke prevention care program |
| Usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure control
Measured: baseline, 3 months, 7 months
Secondary outcomes (4)
control of other stroke risk factors including lipids, smoking, and exercise
Measured: baseline, 3 months, 7 months
patient perceptions of care quality
Measured: baseline, 3 months, 7 months
medication adherence
Measured: baseline, 3 months, 7 months
Stroke knowledge
Open ended questions about the warning signs about stroke. Open ended questions about the risk factors of stroke. These questions evaluate the effectiveness of the didactic portion of the group sessions.
Measured: baseline, 3 months, 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic 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
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sepulveda Research Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Eric M. Cheng, Sepulveda Research Corporation
- Investigators
- Eric M Cheng, MD, MS, Principal investigator, VA Long Beach Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01071408
- Sponsor's protocol ID
- K23NS058571
- Other IDs
- K23NS058571
- Status last verified
- May 2012
- First submitted
- 12 Feb 2010
- Last updated
- 16 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Stroke Prevention Program for an Underserved Minority Community
- ClinicalTrials.gov ID
- NCT01071408
- Acronym / sponsor ID
- K23NS058571
- Conditions
- Ischemic Stroke, Transient Ischemic Attack
- Keywords
- chronic care model, stroke prevention, health services research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Sepulveda Research CorporationIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Mar 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 19 Feb 2010 (estimated)
- 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 determine whether an outpatient program can reduce the risk of recurrent stroke.
Detailed description
Stroke is a major cause of death and disability. A history of stroke is the strongest predictor of a future stroke. Control of risk factors lowers the risk of future stroke, yet most persons with stroke do not have their risk factors controlled.
In this randomized-controlled trial, we will test whether an outpatient stroke prevention program consisting of group clinics, patient self-management, and telephone care coordination can lower the risk of recurrent stroke by improving patient knowledge, medication adherence, and lifestyle habits. If successful, this program may be adapted to other settings.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke Prevention Program + Usual Care | Experimental | Other: Stroke prevention care programStroke Prevention Care Program + Usual Care. The Stroke prevention care program is in addition, not a substitute for usual care. Persons randomized to this arm are eligible to all care, including care by stroke specialists, while enrolled in the intervention. |
| Usual care | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- ischemic stroke within the past 30 days
- transient ischemic attack within the past 30 days
- person receiving care at VA Long Beach Healthcare System
Key exclusion criteria (2 listed)
- unable to understand informed consent
- already enrolled in another research study
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 |
|---|---|---|
| Stroke prevention care programAlso: group clinics, chronic care model, secondary stroke prevention program, nurse practitionerStroke prevention care program consists of group clinics, telephone coordination of care, and tracking of care through registries in the first 7 months after stroke or TIA presentation. A nurse practitioner will follow algorithms to adjust medications and to motivate patients to improve lifestyle habits. | Other | Stroke Prevention Program + Usual Care |
Primary outcome
Blood pressure control
Time frame: baseline, 3 months, 7 months
4 secondary outcomes
control of other stroke risk factors including lipids, smoking, and exercise
Time frame: baseline, 3 months, 7 months
patient perceptions of care quality
Time frame: baseline, 3 months, 7 months
medication adherence
Time frame: baseline, 3 months, 7 months
Stroke knowledge
Time frame: baseline, 3 months, 7 months
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 16 May 2012.
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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.
Eric M Cheng, MD, MS principal investigator
VA Long Beach Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stroke prevention care program in people with Ischemic Stroke and Transient Ischemic Attack, run by Sepulveda Research Corporation 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 3 inclusion and 2 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 16 May 2012. 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. 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?
Blood pressure control (time frame: baseline, 3 months, 7 months). 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 16 May 2012; AzTrials last refreshed its copy on 26 Oct 2026.