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

March 12, 2009
January 6, 2014
January 2010
September 2013   (final data collection date for primary outcome measure)
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.
Blood Pressure [ Time Frame: Baseline, 3 months and 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00861081 on ClinicalTrials.gov Archive Site
  • 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.
  • Lipid levels [ Time Frame: Baseline, 3 month, 12 month ] [ Designated as safety issue: No ]
  • Medication Adherence [ Time Frame: 8 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Intervention to Enable Stroke Survivors in Los Angeles County Hospitals to "Stay Within the Guidelines"
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Stroke
  • 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.
  • 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.
  • Experimental: 1: Care management
    Intervention: Behavioral: Care Management
  • Active Comparator: 2: Written Materials
    Intervention: Behavioral: Written Materials
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
410
September 2013
September 2013   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00861081
G-08-07-019-01, 0875133N
No
Dr. Barbara Vickrey, University of California, Los Angeles
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
University of California, Los Angeles
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP