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Intervention to Enable Stroke Survivors in Los Angeles County Hospitals to "Stay Within the Guidelines" (SUSTAIN)

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ClinicalTrials.gov Identifier: NCT00861081
Recruitment Status : Completed
First Posted : March 13, 2009
Last Update Posted : January 7, 2014
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Stroke Behavioral: Care Management Behavioral: Written Materials

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 410 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: RCT of an Intervention to Enable Stroke Survivors in Los Angeles County Hospitals to "Stay Within the Guidelines" (SUSTAIN)
Study Start Date : January 2010
Primary Completion Date : September 2013
Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1: Care management Behavioral: Care Management
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.
Active Comparator: 2: Written Materials Behavioral: Written Materials
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.

Outcome Measures

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Lipid levels [ Time Frame: 12 month ]
    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.

  2. Medication Adherence [ Time Frame: 8 months ]
    Medication adherence will be measured in a self-report by the subjects.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
Contacts and Locations

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): NCT00861081

United States, California
Rancho Los Amigos National Rehabilitation Center
Downey, California, United States, 90242
Los Angeles, California, United States, 90024
LAC+USC Medical Center
Los Angeles, California, United States, 90033
Olive View-UCLA Medical Center
Sylmar, California, United States, 91342
Harbor-UCLA Medical Center
Torrance, California, United States, 90502
Sponsors and Collaborators
University of California, Los Angeles
University of Southern California
Los Angeles Biomedical Research Institute
Rancho Los Amigos National Rehabilitation Center
Olive View-UCLA Education & Research Institute
American Heart Association
Principal Investigator: Barbara Vickrey, MD, MPH University of California, Los Angeles
More Information

Responsible Party: Dr. Barbara Vickrey, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00861081     History of Changes
Other Study ID Numbers: G-08-07-019-01
First Posted: March 13, 2009    Key Record Dates
Last Update Posted: January 7, 2014
Last Verified: January 2014

Keywords provided by Dr. Barbara Vickrey, University of California, Los Angeles:
Group Clinics
Self Management

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases