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StrokeSUCCEEDNCT01763203

The SUCCEED Trial of Secondary Stroke Prevention

A study testing Care Management+Community Health Worker in people with Stroke and Secondary Stroke Prevention, run by University of California, Los Angeles at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Stroke, Secondary Stroke Prevention
What is being tested?
Care Management+Community Health Worker
Could I receive a placebo?
No, everyone receives an active treatment
How many people
487 participants
Where
6 sitesUnited States
Study dates
13 Feb 2014to 11 Feb 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites
  • Rancho Los Amigos National Rehabilitation Center

    Downey, California, 90242

  • UCLA

    Los Angeles, California, 90024

  • LAC+USC Medical Center

    Los Angeles, California, 90033

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Olive View-UCLA Medical Center

    Sylmar, California, 91342

  • Harbor-UCLA Medical Center

    Torrance, California, 90502

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Care Management+Community Health Worker, Usual Care
Keywords
Self-management, Chronic Care Model, Community health worker
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Care Management+Community Health WorkerBehavioural

    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.

  • Usual CareBehavioural

    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.

Study groups in NCT01763203
Study groupRoleWhat they receive
Care Management+Community Health WorkerExperimentalCare management
Receives: Behavioral: Care Management+Community Health Worker
Usual CareActive comparatorWritten materials
Receives: Behavioral: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Systolic 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.

    Measured: 12 months

Secondary outcomes (19)
  1. Dyslipidemia

    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.

    Measured: 12 months

  2. Percentage of Glycated Hemoglobin (Hemoglobin A1C)

    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.

    Measured: 12 months

  3. Inflammation: C-reactive Protein

    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.

    Measured: 12 months

  4. Body Mass Index

    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.

    Measured: 12 months

  5. Waist Circumference

    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.

    Measured: 12 months

  6. Physical Activity

    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.

    Measured: 12 months

  7. Salt Intake

    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

    Measured: 12 months

  8. Soda Intake

    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

    Measured: 12 months

  9. Fruit and Vegetable Intake

    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

    Measured: 12 months

  10. Smoking

    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.'

    Measured: 12 months

  11. Knowledge About Stroke Signs

    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.

    Measured: 12 months

  12. Knowledge About Stroke Risk Factors

    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.

    Measured: 12 months

  13. Patient Perception of Quality of Stroke Preventative Care

    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'.

    Measured: 12 months

  14. Vascular Events

    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.

    Measured: 12 months

  15. Medication Adherence - Global

    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.

    Measured: 12 Months

  16. Medication Adherence - Blood Pressure Medication

    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.

    Measured: 12 Months

  17. Medication Adherence - Cholesterol Medication

    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.

    Measured: 12 months

  18. Medication Adherence - Antithrombotic Medication

    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.

    Measured: 12 months

  19. Medication Adherence - Antidepressant Medication

    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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2013 (estimated)
  2. Study start13 Feb 2014
  3. Primary completion20 Sep 2018
  4. Study completion11 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
487 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01763203
Sponsor's protocol ID
5155 U54-NS081764
Other IDs
U54NS081764
Acronym
SUCCEED
Status last verified
Nov 2019
First submitted
4 Jan 2013
Last updated
26 Nov 2019
Data monitoring committee
Yes

Publications

  • Towfighi A, Cheng EM, Ayala-Rivera M, McCreath H, Sanossian N, Dutta T, Mehta B, Bryg R, Rao N, Song S, Razmara A, Ramirez M, Sivers-Teixeira T, Tran J, Mojarro-Huang E, Montoya A, Corrales M, Martinez B, Willis P, Macias M, Ibrahim N, Wu S, Wacksman J, Haber H, Richards A, Barry F, Hill V, Mittman B, Cunningham W, Liu H, Ganz DA, Factor D, Vickrey BG. Randomized controlled trial of a coordinated care intervention to improve risk factor control after stroke or transient ischemic attack in the safety net: Secondary stroke prevention by Uniting Community and Chronic care model teams Early to End Disparities (SUCCEED). BMC Neurol. 2017 Feb 6;17(1):24. doi: 10.1186/s12883-017-0792-7.

    PubMed 28166784
  • Schneider AT, Pancioli AM, Khoury JC, Rademacher E, Tuchfarber A, Miller R, Woo D, Kissela B, Broderick JP. Trends in community knowledge of the warning signs and risk factors for stroke. JAMA. 2003 Jan 15;289(3):343-6. doi: 10.1001/jama.289.3.343.

    PubMed 12525235
  • Lu M, Safren SA, Skolnik PR, Rogers WH, Coady W, Hardy H, Wilson IB. Optimal recall period and response task for self-reported HIV medication adherence. AIDS Behav. 2008 Jan;12(1):86-94. doi: 10.1007/s10461-007-9261-4. Epub 2007 Jun 19.

    PubMed 17577653
  • Simoni JM, Kurth AE, Pearson CR, Pantalone DW, Merrill JO, Frick PA. Self-report measures of antiretroviral therapy adherence: A review with recommendations for HIV research and clinical management. AIDS Behav. 2006 May;10(3):227-45. doi: 10.1007/s10461-006-9078-6.

    PubMed 16783535
  • Nicol MB, Thrift AG. Knowledge of risk factors and warning signs of stroke. Vasc Health Risk Manag. 2005;1(2):137-47. doi: 10.2147/vhrm.1.2.137.64085.

    PubMed 17315400
  • Saunders DH, Mead GE, Fitzsimons C, Kelly P, van Wijck F, Verschuren O, Backx K, English C. Interventions for reducing sedentary behaviour in people with stroke. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD012996. doi: 10.1002/14651858.CD012996.pub2.

    PubMed 34184251
  • Towfighi A, Cheng EM, Ayala-Rivera M, Barry F, McCreath H, Ganz DA, Lee ML, Sanossian N, Mehta B, Dutta T, Razmara A, Bryg R, Song SS, Willis P, Wu S, Ramirez M, Richards A, Jackson N, Wacksman J, Mittman B, Tran J, Johnson RR, Ediss C, Sivers-Teixeira T, Shaby B, Montoya AL, Corrales M, Mojarro-Huang E, Castro M, Gomez P, Munoz C, Garcia D, Moreno L, Fernandez M, Lopez E, Valdez S, Haber HR, Hill VA, Rao NM, Martinez B, Hudson L, Valle NP, Vickrey BG; Secondary Stroke Prevention by Uniting Community and Chronic Care Model Teams Early to End Disparities (SUCCEED) Investigators. Effect of a Coordinated Community and Chronic Care Model Team Intervention vs Usual Care on Systolic Blood Pressure in Patients With Stroke or Transient Ischemic Attack: The SUCCEED Randomized Clinical Trial. JAMA Netw Open. 2021 Feb 1;4(2):e2036227. doi: 10.1001/jamanetworkopen.2020.36227.

    PubMed 33587132
  • Lin AM, Vickrey BG, Barry F, Lee ML, Ayala-Rivera M, Cheng E, Montoya AV, Mojarro-Huang E, Gomez P, Castro M, Corrales M, Sivers-Teixeira T, Tran JL, Johnson R, Ediss C, Shaby B, Willis P, Sanossian N, Mehta B, Dutta T, Razmara A, Bryg R, Song S, Towfighi A. Factors Associated With Participation in the Chronic Disease Self-Management Program: Findings From the SUCCEED Trial. Stroke. 2020 Oct;51(10):2910-2917. doi: 10.1161/STROKEAHA.119.028022. Epub 2020 Sep 11.

    PubMed 32912091

Questions about this trial

What is this clinical trial studying?

A study testing Care Management+Community Health Worker in people with Stroke and Secondary Stroke Prevention, run by University of California, Los Angeles at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Systolic Blood Pressure (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01763203, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2019.

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