The SUCCEED Trial of Secondary Stroke Prevention (SUCCEED)

November 24, 2019 updated by: Barbara Vickrey, MD, MPH, University of California, Los Angeles

Secondary Stroke Prevention by Uniting Community and Chronic Care Model Teams Early to End Disparities: the SUCCEED Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
487

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Downey, California, United States, 90242
        • Rancho Los Amigos National Rehabilitation Center
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, United States, 90024
        • UCLA
      • Los Angeles, California, United States, 90033
        • LAC+USC Medical Center
      • Sylmar, California, United States, 91342
        • Olive View-UCLA Medical Center
      • Torrance, California, United States, 90502
        • Harbor-UCLA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients of Los Angeles County+University of Southern California (LAC-USC), Rancho Los Amigos, Olive View-University of California, Los Angeles (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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
12 months
Percentage of Glycated Hemoglobin (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.
12 months
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.
12 months
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.
12 months
Waist Circumference
Time Frame: 12 months
Waist circumference will be measured at 12-months according to the National Institutes of Health (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.
12 months
Physical Activity
Time Frame: 12 months
The International Physical Activity Questionnaire (IPAQ) 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. The IPAQ score reflects energy expenditure of physical activity, and is reported in units of 'met minutes' which means metabolic equivalent. The minimum value is zero and there is no maximum. Higher scores mean better levels of physical activity.
12 months
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
12 months
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
12 months
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
12 months
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.'
12 months
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 3 months to track changes over the follow-up 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.
12 months
Knowledge About Stroke Risk Factors
Time Frame: 12 months
An adaptation of an existing instrument 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.
12 months
Patient Perception of Quality of Stroke Preventative Care
Time Frame: 12 months
An adaptation of the Consumer Assessment of Healthcare Providers and Systems (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. The CAHPS question was "Did you receive from any of your medical care providers the help you needed to make changes in your habits or lifestyle that would improve your health or prevent illness?" Response choices are: 'Yes definitely' "Yes somewhat' or 'No definitely not'.
12 months
Vascular Events
Time Frame: 12 months
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. The scoring was dichotomous: at least one new event (stroke, transient ischemic attack, or heart attack) versus none over the 12-month follow-up period.
12 months
Medication Adherence - Global
Time Frame: 12 Months
A single item adapted from two questions published elsewhere 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.
12 Months
Medication Adherence - Blood Pressure 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 blood pressure medication, using a previously published formula. This will also be collected at 3 months, to track changes over the study period.
12 Months
Medication Adherence - Cholesterol 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 cholesterol medication, using a previously published formula. This will also be collected at 3 Months, to track changes over the study period.
12 months
Medication Adherence - Antithrombotic 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 antithrombotic medication, using a previously published formula. This will also be collected at 3 Months, to track changes over the study period.
12 months
Medication Adherence - Antidepressant 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 antidepressant medication, using a previously published formula. This will also be collected at 3 Months, to track changes over the study period.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Los Angeles

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Neurological Disorders and Stroke (NINDS)
University of Southern California
Cedars-Sinai Medical Center
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Olive View-UCLA Education & Research Institute
Rancho Los Amigos National Rehabilitation Center
California Community Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 13, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 20, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 11, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 8, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 26, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 5155 U54-NS081764
  • U54NS081764 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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