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

Stroke Clinical Trial

— SUSTAIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00861081
• Other study ID #: G-08-07-019-01
• Secondary ID: 0875133N
• Status: Completed
• Phase: N/A
• Start date: January 2010
• Est. completion date: September 2013

Study information

• Verified date: June 2018
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 410
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Rancho Los Amigos National Rehabilitation Center	Downey	California
United States	LAC+USC Medical Center	Los Angeles	California
United States	UCLA	Los Angeles	California
United States	Olive View-UCLA Medical Center	Sylmar	California
United States	Harbor-UCLA Medical Center	Torrance	California

Sponsors (6)

Lead Sponsor	Collaborator
University of California, Los Angeles	American Heart Association, Los Angeles Biomedical Research Institute, Olive View-UCLA Education & Research Institute, Rancho Los Amigos National Rehabilitation Center, University of Southern California

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Secondary	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.	12 month
Secondary	Medication Adherence	Medication adherence will be measured in a self-report by the subjects.	8 months