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Trial record 2 of 2 for:    vickrey | Stroke

The SUCCEED Trial of Secondary Stroke Prevention (SUCCEED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01763203
Recruitment Status : Active, not recruiting
First Posted : January 8, 2013
Last Update Posted : July 9, 2019
Sponsor:
Collaborators:
University of Southern California
Los Angeles Biomedical Research Institute
Rancho Los Amigos National Rehabilitation Center
Olive View-UCLA Education & Research Institute
National Institute of Neurological Disorders and Stroke (NINDS)
California Community Foundation
Cedars-Sinai Medical Center
Information provided by (Responsible Party):
Barbara Vickrey, MD, MPH, University of California, Los Angeles

Brief Summary:
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 or disease Intervention/treatment Phase
Stroke Secondary Stroke Prevention Behavioral: Care Management+Community Health Worker Behavioral: Usual Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 487 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : September 2013
Actual Primary Completion Date : September 2018
Estimated Study Completion Date : August 2019

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Systolic 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 Outcome Measures :
  1. Dyslipidemia [ Time Frame: 12 months ]
    non-HDL 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. Hemoglobin A1C [ Time Frame: 12 months ]
    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.

  3. Inflammation: C-reactive protein [ Time Frame: 12 months ]
    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.

  4. Body mass index [ Time Frame: 12 months ]
    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.

  5. Hip and Waist Circumference [ Time Frame: 12 months ]
    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.

  6. Physical activity [ Time Frame: 12 months ]
    The International Physical Activity Questionnaire Short 7-Day version 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

  7. Salt intake [ Time Frame: 12 months ]
    A single question, "Are you currently watching or reducing your sodium or salt intake?" from the Behavioral Risk Factor Surveillance System 2013, which has a dichotomous 'yes/no' response, will be collected as part of the 12 month outcome survey. The question will also be collected at baseline, 3 months, and at 8 months, to track changes over the entire study period

  8. Soda intake [ Time Frame: 12 months ]
    A single question from the California Health Interview Survey (CHIS) 2011-2012 will be collected as part of the 12-month outcome survey. The question is "During the past month, how often did you drink regular soda or pop that contains sugar?" The participant gives a number, and the frequency (per day, per week, or per month) is also recorded. The average daily servings of soda over the prior month is calculated, and the question is scored as a dichotomous variable of greater than or equal to 1 serving of soda per /day versus less than one serving of soda per day. The question will also be collected at baseline and at 3 months, to track changes over the entire study period

  9. Fruit and vegetable intake [ Time Frame: 12 months ]
    Two questions from the California Health Interview Survey (CHIS) 2011-2012 will be collected as part of the 12-month outcome survey. The questions are "During the past month, how many times did you eat fruit? Do not count juices" and "During the past month, how many times did you eat any other vegetables like green salad, green beans or potatoes? Do not include fried potatoes." For each question, the participant gives a number, and the frequency (per day, per week, or per month) is also recorded. Responses are converted to a number for day for each question, then summed across the two questions. The question is scored as a dichotomous variable of five or more servings of fruit and vegetables per day versus less than five servings of fruit and vegetables per day. The questions will also be collected at baseline and at 3 months, to track changes over the entire study period

  10. Smoking [ Time Frame: 12 months ]
    A single question from the California Health Interview Survey 2011-2012 Adult Questionnaire will be collected as part of the 12-month outcome survey. The question asks whether over the interval since the previous study interview, "were you smoking cigarettes every day, some days, or not at all?" The question will also be collected at baseline (with a time frame of over the prior year) and at 3 months, to track changes over the entire study period. The scoring for this outcome is dichotomous: "Smoking" = a response of 'every day' or 'some days', versus "Not smoking" = a response of 'not at all.'

  11. Knowledge about stroke signs [ Time Frame: 12 months ]
    An open-ended question about what the participant believes is a sign of a stroke ("What are the warning signs of a stroke? What else...what else?"), will be asked as a part of the 12 month survey. This question will also be collected at baseline and at 3 months to track changes over the entire study period. Correct responses are numbness, weakness, difficulty speaking/understanding, vision disturbance, dizziness, and headache. Responses are scored as 0 correct, 1 correct, 2 correct, and 3 or more correct, per the reference of Nicol and Thrift, Vascular Health and Risk Management, 2005:1(2) 137-147.

  12. Knowledge about stroke risk factors [ Time Frame: 12 months ]
    An adaptation of the instrument from Schneider et al (JAMA 2003;289:343-346) will be collected as a part of the 12 month survey. An open-ended question about what the participant believes is a stroke risk factor ("I would like to ask you about stroke risk factors, those are the things that make it more likely for somebody to have a stroke. From anything you might have heard or read, what do you believe are the risk factors associated with stroke? What else...what else?", will be asked, then converted to three dichotomous variables: correct about at least 3 stroke risk factors versus less than three; correct about at least one stroke risk factor versus none correct; and reports that blood pressure is a stroke risk factor versus does not. This question will also be collected at baseline, 3 months, and 8 months to track changes over the entire study period.

  13. Patient perception of quality of stroke preventative care [ Time Frame: 12 months ]
    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

  14. Vascular events [ Time Frame: Up to 24 months after study completion ]
    The Questionnaire for Verifying Stroke Free Status (QVSFS) will be collected as part of the 12 month survey. It will also be collected at baseline and 3 months to track changes over the entire study period. This questionnaire will also be collected every 6 months for up to 24 months after the study is completed to check for vascular events.

  15. Medication Adherence - global [ Time Frame: 12 Months ]
    A single item adapted from two questions in Lu M, Safron SA, Skolnik PR, et al (AIDS Behav 2008;12:86-94) will be administered at 12 months. The adapted item is "In the past week, how much of the time were you able to take your medications exactly as your doctor or nurse told you to?" Response choices are 'None of the time,' 'A little of the time,' "A good bit of the time,' 'Most of the time,' or 'All of the time.' This item will also be collected at Baseline, 3 Months, and 8 Months, to track changes over the entire study period.

  16. Medication Adherence - by medication [ Time Frame: 12 Months ]
    A continuous measure of adherence as percentage of doses taken over the prior 7-day time period will be collected at 12 months and calculated for each of four categories of medications (blood pressure, cholesterol, antithrombotic, and antidepressant), using the formula from Simoni JM, Kurth AE, Pearson CR, et al, AIDS Behav (2006) 10, page 237. These will also be collected at Baseline and at 3 Months, to track changes over the entire study period.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 130 mm Hg or greater OR Systolic blood pressure is between 120 mm Hg and 130 mm Hg and there is diagnosed/treated hypertension prior to the stroke or TIA

Exclusion Criteria:

  • Younger than 40 years
  • Systolic Blood Pressure less than 120 mm Hg OR systolic blood pressure is between 120 mm Hg and 130 mm Hg and there is no known history of hypertension prior to the stroke or TIA
  • Speaks language other than English, Spanish, Korean, Mandarin, and Cantonese
  • Inability to comprehend the study because of communication or cognitive impairments

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01763203


Locations
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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
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
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
National Institute of Neurological Disorders and Stroke (NINDS)
California Community Foundation
Cedars-Sinai Medical Center
Investigators
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Principal Investigator: Barbara G Vickrey, MD, MPH Icahn School of Medicine at Mount Sinai
Principal Investigator: Amytis Towfighi, MD USC - Department of Neurology. Rancho Los Amigos National Rehabilitation Center

Publications:
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Responsible Party: Barbara Vickrey, MD, MPH, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01763203     History of Changes
Other Study ID Numbers: 5155 U54-NS081764
U54NS081764 ( U.S. NIH Grant/Contract )
First Posted: January 8, 2013    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019

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

Additional relevant MeSH terms:
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Stroke
Neoplasm Metastasis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes