The SUCCEED Trial of Secondary Stroke Prevention

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
University of Southern California
Los Angeles Biomedical Research Institute
Rancho Los Amigos National Rehabilitation Center
Olive View-UCLA Education & Research Institute
Information provided by (Responsible Party):
Dr. Barbara Vickrey, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01763203
First received: January 4, 2013
Last updated: February 5, 2013
Last verified: February 2013
  Purpose

The purpose of this study is to test a newly-developed outpatient clinic and community-based care intervention called SUCCEED (Secondary stroke prevention by Uniting Community and Chronic care model teams Early to End Disparities) for improving control of stroke risk factors among stroke patients in the Los Angeles County "safety net", and to measure the costs of running such an intervention, relative to usual care.


Condition Intervention
Stroke
Secondary Stroke Prevention
Behavioral: Care Management+Community Health Worker
Behavioral: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Secondary Stroke Prevention by Uniting Community and Chronic Care Model Teams Early to End Disparities: the SUCCEED Trial

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Systolic blood pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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:
  • Dyslipidemia [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    LDL 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.

  • Hemoglobin A1C [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Hemoglobin A1C 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.

  • Inflammation: C-reactive protein [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    C-reactive protein 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.

  • Body mass index [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Body mass index will be measured at 12-months with a height and weight ratio. The same measurements will be taken at baseline and at the 3 month mark in order to track measurements throughout the entire participation period.

  • Hip and Waist Circumference [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Hip and Waist circumference will be measured at 12-months according to the NIH guidelines. The same measurements will be taken at baseline and at the 3 month mark in order to track measurements throughout the entire participation period.

  • Physical activity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The International Physical Activity questionnaire will be collected as part of the 12 month outcome survey. The questionnaire will also be collected at baseline and 3 months to track changes over the entire study period

  • Diet [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Eating Pattern Questionnaire will be collected as part of the 12 month outcome survey. The questionnaire will also be collected at baseline and 3 months to track changes over the entire study period

  • Smoking [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Smoking Section of CHIS 2009 Adult Questionnaire will be collected as part of the 12 month outcome survey. The questionnaire will also be collected at baseline, 3 months, and 8 month to track changes over the entire study period

  • Knowledge about stroke signs and risk factors [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    an adaptation of Stroke Factor Survey will be collected as a part of the 12 month survey. This survey will also be collected at baseline and 3 month to track changes over the entire study period,

  • Patient perception of quality of stroke preventative care [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    An adaptation of the CAHPS will be collected as a part of the 12 month questionnaire. It will also be collected at baseline and 3 month to track changes over the entire study period

  • Vascular events [ Time Frame: Up to 18 months after study completion ] [ Designated as safety issue: No ]
    The questionnaire for Verifying Stroke Free Status (QVSS)will be collected as part of the 12 month survey. It will also be collected at baseline, 3 months and 8 months to track changes over the entire study period. This questionnaire will also be collected every 6 months for up to 18 months after the study is completed to check for vascular events.

  • Medication Adherence [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    The Morisky Medication Adherence scale and an adaptation of ASK (Adherence Starts with Knowledge) will be collected at 12 months. It will also be collected at Baseline, 3 Months, and 8 Months to track changes over the entire study period.


Estimated Enrollment: 500
Study Start Date: September 2013
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Care Management+Community Health Worker
Care management
Behavioral: Care Management+Community Health Worker
Over a period of a year subjects randomized into the Intervention arm of the study will receive support from a Care Manager. Subjects will also participate in educational group sessions on chronic disease self-management and have home visits by a Community Health Worker who will use mobile health technology.
Active Comparator: Usual Care
Written materials
Behavioral: Usual Care
Subjects randomized into the Usual Care arm will receive educational materials about stroke distributed to the Intervention patients and will receive their post-stroke care as usual.

Detailed Description:

Individuals randomized to the intervention arm will receive care from a team that consists of a care manager(CM) who is either a nurse practitioner (NP) or physician assistant (PA), supervised by the site PI, and a community health worker (CHW). The CM will follow care protocols developed by the research team. The CHW will serve as a liaison between the patient and the health care system, and mobilize resources and system support to reduce social isolation and improve stroke risk factor control self-management, through a series of workshops and home visits. Intervention participants will receive home blood pressure monitors. Subjects in either arm are eligible to receive their usual source of care. Five hundred participants who have had a stroke or TIA will be enrolled, randomized to the intervention or to usual care in a 1:1 ratio, and followed for 12 months. The impact of the intervention on systolic blood pressure is the primary study outcome; secondary outcomes are other stroke risk factors. Enrollment will occur at four sites in Los Angeles County, and the study sample is projected to include over 90% socioeconomically disadvantaged individuals from minority groups.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients of LAC+USC, Rancho Los Amigos, Olive View-UCLA, or Harbor-UCLA
  • Transient ischemic attack (TIA), ischemic stroke or hemorrhagic stroke within the prior 90 days
  • English, Spanish, Korean, Mandarin or Cantonese-speaking
  • 40 years of age or older
  • Capable of giving informed consent (no proxies will be used to obtain consent)
  • Systolic blood pressure is 120 mm Hg or greater

Exclusion Criteria:

  • Younger than 40 years
  • Systolic Blood Pressure less than 120 mm Hg
  • Speaks language other than English, Spanish, Korean, Mandarin, and Cantonese
  • Inability to comprehend the study because of communication or cognitive impairments
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01763203

Locations
United States, California
Rancho Los Amigos National Rehabilitation Center
Downey, California, United States, 90242
UCLA
Los Angeles, California, United States, 90024
LAC+USC Medical Center
Los Angeles, California, United States, 90033
Olive View-UCLA Medical Center
Sylmar, California, United States, 91342
Harbor-UCLA Medical Center
Torrance, California, United States, 90502
Sponsors and Collaborators
University of California, Los Angeles
University of Southern California
Los Angeles Biomedical Research Institute
Rancho Los Amigos National Rehabilitation Center
Olive View-UCLA Education & Research Institute
Investigators
Principal Investigator: Barbara G Vickrey, MD, MPH University of California, Los Angeles
Principal Investigator: Amytis Towfighi, MD USC - Department of Neurology. Rancho Los Amigos National Rehabilitation Center
  More Information

No publications provided

Responsible Party: Dr. Barbara Vickrey, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01763203     History of Changes
Other Study ID Numbers: 5155 U54-NS081764, U54NS081764
Study First Received: January 4, 2013
Last Updated: February 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Self-management
Chronic Care Model
Community health worker

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 24, 2014