The SUCCEED Trial of Secondary Stroke Prevention "SUCCEED"

Enrolling by invitation

Phase N/A Results N/A

Trial Description

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.

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.

Conditions

Interventions

  • Usual care Other
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Usual Care
    Description: Written materials
  • Care Management+Community Health Worker Behavioral
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Care Management+Community Health Worker
    Description: Care management

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Health Services Research
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Systolic blood pressure 12 months No
Secondary Dyslipidemia 12 months No
Secondary Hemoglobin A1C 12 months No
Secondary Inflammation: C-reactive protein 12 months No
Secondary Body mass index 12 months No
Secondary Body fat distribution 12 months No
Secondary Physical activity 12 months No
Secondary Diet 12 months No
Secondary Smoking 12 months No
Secondary Knowledge about stroke signs and risk factors 12 months No
Secondary Patient perception of quality of stroke preventative care 12 months No
Secondary Medication adherence 12 months No
Secondary Vascular events Up to 18 months after study completion No
Secondary Hip and Waist Circumference 12 months No

Sponsors