StrokeSUSTAINNCT00861081
Intervention to Enable Stroke Survivors in Los Angeles County Hospitals to "Stay Within the Guidelines"
A study testing Care Management and Written Materials in people with Stroke, run by University of California, Los Angeles at 5 sites in United States.
Trial summary
The purpose of this study is to test a newly developed outpatient care intervention called SUSTAIN (Systematic Use of Stroke Averting Interventions) for improving delivery of stroke preventive services at Los Angeles County hospitals and to measure the costs of running such an intervention. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Care Management and Written Materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2010to Sep 2013
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of LAC+USC, Rancho Los Amigos, Olive View-UCLA, or Harbor-UCLA
- Patients who have had an acute transient ischemic attack (TIA) or ischemic stroke or carotid procedure within the last six months
- English or Spanish speaking
- At least 40 years of age
- Capable of giving informed consent (no proxies will be used to obtain consent)
- Blood pressure not optimally controlled (>120/80, at least 72 hours post-stroke)
Who cannot join
- Age 39 years or younger
- Hemorrhagic stroke
- Patients with severe global disability which would preclude him/her from participating in group clinics
- Patients with advanced dementia
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Rancho Los Amigos National Rehabilitation Center
Downey, California, 90242
UCLA
Los Angeles, California, 90024
LAC+USC Medical Center
Los Angeles, California, 90033
Olive View-UCLA Medical Center
Sylmar, California, 91342
Harbor-UCLA Medical Center
Torrance, California, 90502
About this study
Official title: RCT of an Intervention to Enable Stroke Survivors in Los Angeles County Hospitals to "Stay Within the Guidelines" (SUSTAIN)
The purpose of this study is to test a newly developed outpatient care intervention called SUSTAIN (Systematic Use of Stroke Averting Interventions) for improving delivery of stroke preventive services at Los Angeles County hospitals and to measure the costs of running such an intervention.
Read the detailed description
Patients randomized to SUSTAIN will participate in group clinics about stroke, given self-management tools about stroke, and will be called by nurse practitioners to coordinate their stroke care. Patients randomized to the control arm will be mailed educational materials about stroke. Subjects in either arm are eligible to receive their usual source of care.
- Conditions
- Stroke
- Being tested
- Care Management, Written Materials
- Keywords
- Group Clinics, Self Management
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care ManagementBehavioural
Over a period of one year, subjects will participate in two regular stroke clinics, three group clinics, obtain self-management tools, and will receive a series of four scheduled telephone calls by nurse practitioners to review information delivered during the group clinics and help with care coordination. Usual care will also be available.
Written MaterialsBehavioural
Educational materials about stroke that will be distributed during the group clinic session will be mailed to these subjects. These materials have been developed by the American Heart Association. Usual care will also be available.
| Study group | Role | What they receive |
|---|---|---|
| 1: Care management | Experimental | Not described Receives: Behavioral: Care Management |
| 2: Written Materials | Active comparator | Not described Receives: Behavioral: Written Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Blood pressure at 12 months will be the primary outcome. Blood pressure will also be measured at baseline and at the 3-month mark to track blood pressure during the entire participation period.
Measured: 12 months
Secondary outcomes (2)
Lipid levels
LDL, HDL, triglycerides and total cholesterol will be measured at 12-months. The same measurements will be taken at baseline and at the 3 month mark in order to track measurements throughout the entire participation period.
Measured: 12 month
Medication Adherence
Medication adherence will be measured in a self-report by the subjects.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2009 (estimated)
- Study startJan 2010
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern California, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Rancho Los Amigos National Rehabilitation Center, Olive View-UCLA Education & Research Institute, American Heart Association
- Responsible party
- Principal investigator, Barbara Vickrey, MD, MPH, University of California, Los Angeles
- Investigators
- Barbara Vickrey, MD, MPH, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00861081
- Sponsor's protocol ID
- G-08-07-019-01
- Other IDs
- 0875133N
- Acronym
- SUSTAIN
- Status last verified
- Jun 2018
- First submitted
- 12 Mar 2009
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Cheng EM, Cunningham WE, Towfighi A, Sanossian N, Bryg RJ, Anderson TL, Guterman JJ, Gross-Schulman SG, Beanes S, Jones AS, Liu H, Ettner SL, Saver JL, Vickrey BG. Randomized, controlled trial of an intervention to enable stroke survivors throughout the Los Angeles County safety net to "stay with the guidelines". Circ Cardiovasc Qual Outcomes. 2011 Mar;4(2):229-34. doi: 10.1161/CIRCOUTCOMES.110.951012.
PubMed 21406671Cheng EM, Cunningham WE, Towfighi A, Sanossian N, Bryg RJ, Anderson TL, Barry F, Douglas SM, Hudson L, Ayala-Rivera M, Guterman JJ, Gross-Schulman S, Beanes S, Jones AS, Liu H, Vickrey BG. Efficacy of a Chronic Care-Based Intervention on Secondary Stroke Prevention Among Vulnerable Stroke Survivors: A Randomized Controlled Trial. Circ Cardiovasc Qual Outcomes. 2018 Jan;11(1):e003228. doi: 10.1161/CIRCOUTCOMES.116.003228.
PubMed 29321134Richards A, Jackson NJ, Cheng EM, Bryg RJ, Brown A, Towfighi A, Sanossian N, Barry F, Li N, Vickrey BG. Derivation and Application of a Tool to Estimate Benefits From Multiple Therapies That Reduce Recurrent Stroke Risk. Stroke. 2020 May;51(5):1563-1569. doi: 10.1161/STROKEAHA.119.027160. Epub 2020 Mar 23.
PubMed 32200759
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT of an Intervention to Enable Stroke Survivors in Los Angeles County Hospitals to "Stay Within the Guidelines" (SUSTAIN)
- ClinicalTrials.gov ID
- NCT00861081
- Acronym / sponsor ID
- SUSTAIN / G-08-07-019-01
- Conditions
- Stroke
- Keywords
- Group Clinics, Self Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 410 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- University of Southern California, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Rancho Los Amigos National Rehabilitation Center, Olive View-UCLA Education & Research Institute, American Heart Association
- Study start
- Jan 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 13 Mar 2009 (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 test a newly developed outpatient care intervention called SUSTAIN (Systematic Use of Stroke Averting Interventions) for improving delivery of stroke preventive services at Los Angeles County hospitals and to measure the costs of running such an intervention.
Detailed description
Patients randomized to SUSTAIN will participate in group clinics about stroke, given self-management tools about stroke, and will be called by nurse practitioners to coordinate their stroke care. Patients randomized to the control arm will be mailed educational materials about stroke. Subjects in either arm are eligible to receive their usual source of care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: Care management | Experimental | Behavioral: Care Management |
| 2: Written Materials | Active comparator | Behavioral: Written Materials |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients of LAC+USC, Rancho Los Amigos, Olive View-UCLA, or Harbor-UCLA
- Patients who have had an acute transient ischemic attack (TIA) or ischemic stroke or carotid procedure within the last six months
- English or Spanish speaking
- At least 40 years of age
- Capable of giving informed consent (no proxies will be used to obtain consent)
Key exclusion criteria (4 listed)
- Age 39 years or younger
- Hemorrhagic stroke
- Patients with severe global disability which would preclude him/her from participating in group clinics
- Patients with advanced dementia
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 |
|---|---|---|
| Care ManagementOver a period of one year, subjects will participate in two regular stroke clinics, three group clinics, obtain self-management tools, and will receive a series of four scheduled telephone calls by nurse practitioners to review information delivered during the group clinics and help with care coordination. Usual care will also be available. | Behavioural | 1: Care management |
| Written MaterialsEducational materials about stroke that will be distributed during the group clinic session will be mailed to these subjects. These materials have been developed by the American Heart Association. Usual care will also be available. | Behavioural | 2: Written Materials |
Primary outcome
Blood Pressure
Time frame: 12 months
Blood pressure at 12 months will be the primary outcome. Blood pressure will also be measured at baseline and at the 3-month mark to track blood pressure during the entire participation period.
2 secondary outcomes
Lipid levels
Time frame: 12 month
Medication Adherence
Time frame: 8 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 6 Jun 2018.
- Background: PubMed 21406671Cheng EM, Cunningham WE, Towfighi A, Sanossian N, Bryg RJ, Anderson TL, Guterman JJ, Gross-Schulman SG, Beanes S, Jones AS, Liu H, Ettner SL, Saver JL, Vickrey BG. Randomized, controlled trial of an intervention to enable stroke survivors throughout the Los Angeles County safety net to "stay with the guidelines". Circ Cardiovasc Qual Outcomes. 2011 Mar;4(2):229-34. doi: 10.1161/CIRCOUTCOMES.110.951012.
- Results publication: PubMed 29321134Cheng EM, Cunningham WE, Towfighi A, Sanossian N, Bryg RJ, Anderson TL, Barry F, Douglas SM, Hudson L, Ayala-Rivera M, Guterman JJ, Gross-Schulman S, Beanes S, Jones AS, Liu H, Vickrey BG. Efficacy of a Chronic Care-Based Intervention on Secondary Stroke Prevention Among Vulnerable Stroke Survivors: A Randomized Controlled Trial. Circ Cardiovasc Qual Outcomes. 2018 Jan;11(1):e003228. doi: 10.1161/CIRCOUTCOMES.116.003228.
- Derived from this study: PubMed 32200759Richards A, Jackson NJ, Cheng EM, Bryg RJ, Brown A, Towfighi A, Sanossian N, Barry F, Li N, Vickrey BG. Derivation and Application of a Tool to Estimate Benefits From Multiple Therapies That Reduce Recurrent Stroke Risk. Stroke. 2020 May;51(5):1563-1569. doi: 10.1161/STROKEAHA.119.027160. Epub 2020 Mar 23.
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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.
Barbara Vickrey, MD, MPH principal investigator
University of California, Los Angeles
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care Management and Written Materials in people with Stroke, run by University of California, Los Angeles at 5 sites 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 6 inclusion and 4 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 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00861081, which also lists 3 linked publications.
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 6 Jun 2018.