NCT01763203

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
487

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 8, 2013

Completed
1.1 years until next milestone

Study Start

First participant enrolled

February 13, 2014

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2019

Completed
10 months until next milestone

Results Posted

Study results publicly available

November 26, 2019

Completed
Last Updated

November 26, 2019

Status Verified

November 1, 2019

Enrollment Period

4.6 years

First QC Date

January 4, 2013

Results QC Date

August 31, 2019

Last Update Submit

November 24, 2019

Conditions

StrokeSecondary Stroke Prevention

Keywords

Self-managementChronic Care ModelCommunity health worker

Outcome Measures

Primary Outcomes (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.

    12 months

Secondary Outcomes (19)

  • Dyslipidemia

    12 months

  • Percentage of Glycated Hemoglobin (Hemoglobin A1C)

    12 months

  • Inflammation: C-reactive Protein

    12 months

  • Body Mass Index

    12 months

  • Waist Circumference

    12 months

  • +14 more secondary outcomes

Study Arms (2)

Care Management+Community Health Worker

EXPERIMENTAL

Care management

Behavioral: Care Management+Community Health Worker

Usual Care

ACTIVE COMPARATOR

Written materials

Behavioral: Usual Care

Interventions

Care Management+Community Health WorkerBEHAVIORAL

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.

Care Management+Community Health Worker
Usual CareBEHAVIORAL

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.

Usual Care

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Rancho Los Amigos National Rehabilitation Center

Downey, California, 90242, United States

Location

UCLA

Los Angeles, California, 90024, United States

Location

LAC+USC Medical Center

Los Angeles, California, 90033, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Olive View-UCLA Medical Center

Sylmar, California, 91342, United States

Location

Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

Related Publications (8)

  • 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.

    PMID: 28166784BACKGROUND

  • 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.

    PMID: 12525235BACKGROUND

  • 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.

    PMID: 17577653BACKGROUND

  • 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.

    PMID: 16783535BACKGROUND

  • 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.

    PMID: 17315400BACKGROUND

  • 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.

    PMID: 34184251DERIVED

  • 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.

    PMID: 33587132DERIVED

  • 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.

    PMID: 32912091DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Limitations and Caveats

The primary study limitation was the lack of full implementation of the multi-component care management interventions within the intervention arm.

Results Point of Contact

Title
Dr. Barbara Vickrey; Chair of Neurology
Organization
Icahn School of Medicine at Mount Sinai
barbara.vickrey@mssm.edu
2122415698

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 4, 2013

First Posted

January 8, 2013

Study Start

February 13, 2014

Primary Completion

September 20, 2018

Study Completion

February 11, 2019

Last Updated

November 26, 2019

Results First Posted

November 26, 2019

Record last verified: 2019-11

Locations

US(6)