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

This study has been completed.
Sponsor:
Collaborators:
University of Southern California
Los Angeles Biomedical Research Institute
Rancho Los Amigos National Rehabilitation Center
Olive View-UCLA Education & Research Institute
American Heart Association
Information provided by (Responsible Party):
Dr. Barbara Vickrey, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00861081
First received: March 12, 2009
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

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 Intervention
Stroke
Behavioral: Care Management
Behavioral: Written Materials

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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)

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Blood Pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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:
  • Lipid levels [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    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.

  • Medication Adherence [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    Medication adherence will be measured in a self-report by the subjects.


Enrollment: 410
Study Start Date: January 2010
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00861081

Locations
United States, California
Rancho Los Amigos National Rehabilitation Center
Downey, California, United States, 90242
UCLA
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
Investigators
Principal Investigator: Barbara Vickrey, MD, MPH University of California, Los Angeles
  More Information

Publications:
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, 0875133N
Study First Received: March 12, 2009
Last Updated: January 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Group Clinics
Self Management

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 20, 2014