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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)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00861081
Acronym
SUSTAIN
Enrollment
410
Registered
2009-03-13
Start date
2010-01-31
Completion date
2013-09-30
Last updated
2018-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Group Clinics, Self Management

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.

Interventions

BEHAVIORALCare 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.

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.

Sponsors

University of Southern California
CollaboratorOTHER
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
CollaboratorOTHER
Rancho Los Amigos National Rehabilitation Center
CollaboratorOTHER
Olive View-UCLA Education & Research Institute
CollaboratorOTHER
American Heart Association
CollaboratorOTHER
University of California, Los Angeles
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Blood Pressure12 monthsBlood 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

MeasureTime frameDescription
Lipid levels12 monthLDL, 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 Adherence8 monthsMedication adherence will be measured in a self-report by the subjects.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026