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Completed

NCT Number: NCT00861081

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rancho Los Amigos National Rehabilitation Center, Downey, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Care management

Behavioral

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

Behavioral

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 outcomes

  1. Blood Pressure

    Time frame: 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 outcomes

  1. Lipid levels

    Time frame: 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.

  2. Medication Adherence

    Time frame: 8 months

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

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

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

Registry information

Official study title

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

Acronym: SUSTAIN

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Mar 13, 2009
Registry last updated
Jun 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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