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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Care Management
Written Materials
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stroke focused on measuring Group Clinics, Self Management

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rancho Los Amigos National Rehabilitation Center
  • UCLA
  • LAC+USC Medical Center
  • Olive View-UCLA Medical Center
  • Harbor-UCLA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1: Care management

2: Written Materials

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Medication Adherence
Medication adherence will be measured in a self-report by the subjects.

Full Information

First Posted
March 12, 2009
Last Updated
June 2, 2018
Sponsor
University of California, Los Angeles
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
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1. Study Identification

Unique Protocol Identification Number
NCT00861081
Brief Title
Intervention to Enable Stroke Survivors in Los Angeles County Hospitals to "Stay Within the Guidelines"
Acronym
SUSTAIN
Official Title
RCT of an Intervention to Enable Stroke Survivors in Los Angeles County Hospitals to "Stay Within the Guidelines" (SUSTAIN)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
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

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Group Clinics, Self Management

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
410 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1: Care management
Arm Type
Experimental
Arm Title
2: Written Materials
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Care Management
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Written Materials
Intervention Description
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.
Primary Outcome Measure Information:
Title
Blood Pressure
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Lipid levels
Description
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.
Time Frame
12 month
Title
Medication Adherence
Description
Medication adherence will be measured in a self-report by the subjects.
Time Frame
8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Vickrey, MD, MPH
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rancho Los Amigos National Rehabilitation Center
City
Downey
State/Province
California
ZIP/Postal Code
90242
Country
United States
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
LAC+USC Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Olive View-UCLA Medical Center
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States
Facility Name
Harbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21406671
Citation
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.
Results Reference
background
PubMed Identifier
29321134
Citation
Cheng 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.
Results Reference
result
PubMed Identifier
32200759
Citation
Richards 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.
Results Reference
derived

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

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