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

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Behavioral: Care Management; Behavioral: Written Materials

• Registration Number: NCT00861081
• Lead Sponsor: University of California, Los Angeles

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.

Study Timeline

• Study First Submitted: 2009-03-12
• Study First Submitted QC: 2009-03-12
• Study First Posted: 2009-03-13
• Study Start: 2010-01
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-02
• Last Update Posted: 2018-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 410

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1: Care management	Care Management	-
2: Written Materials	Written Materials	-

Primary Outcome Measures

Name	Time	Method
Blood Pressure	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

Name	Time	Method
Lipid levels	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.
Medication Adherence	8 months	Medication adherence will be measured in a self-report by the subjects.

Trial Locations

Locations (5)

Harbor-UCLA Medical Center; 🇺🇸 Torrance, California, United States

LAC+USC Medical Center; 🇺🇸 Los Angeles, California, United States

Rancho Los Amigos National Rehabilitation Center; 🇺🇸 Downey, California, United States

UCLA; 🇺🇸 Los Angeles, California, United States

Olive View-UCLA Medical Center; 🇺🇸 Sylmar, California, United States