NCT02251834

Brief Summary

Stroke is a leading cause of death and functional impairments and stroke risk factors (SRFs) disproportionately affect Latino populations. In the Hispanic Secondary Stroke Prevention Initiative (HISSPI) the investigators propose a study using Community Health Workers (CHW) and mobile technologies using cell phones to reduce the risk for a recurrent stroke among Latino stroke patients. The project examines the effectiveness of a combined multilevel intervention consisting of Community Health Workers (CHW) and mobile based phone technologies in lowering of systolic blood pressure (SBP) which is the most important risk factor for recurrent stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

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

September 25, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 29, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2019

Completed
Last Updated

June 20, 2019

Status Verified

June 1, 2019

Enrollment Period

4.5 years

First QC Date

September 25, 2014

Last Update Submit

June 18, 2019

Conditions

Stroke

Keywords

Healthcare DisparitiesstrokeHispanic Americanscommunity health workerMobile HealthTransient Ischemic Attack (TIA)hypertensionRandomized Controlled Trialhigh cholesterolbehavioralexercisediabetesdiet

Outcome Measures

Primary Outcomes (1)

  • Blood Pressure

    Our primary hypothesis is that at twelve months, patients in the intervention arm will have SBP on average, 8mmHg lower than those in the control group.

    one year

Secondary Outcomes (3)

  • LDL

    one year

  • Self-reported adherence to statins and anti-platelet medications

    one year

  • A1C

    one year

Study Arms (2)

Community Health Worker

EXPERIMENTAL

Community Health Worker (CHW) home visits, coaching phone calls, group sessions .

Behavioral: Community Health Worker (CHW)

Usual Care

OTHER

usual care and health education brochures every 4 months.

Other: usual care and health education brochures every 4 months.

Interventions

Community Health Worker (CHW)BEHAVIORAL

The primary mechanism used by the Community Health Worker (CHW) for delivering interventions will be a) home visits b) phone based contacts c) group level activities d) mobile technology. Ideally, each subject will have, at a minimum, 4 home visits and ten phone calls during months 3-12. Group visits will held twice a month. The Community Health Worker (CHW) intervention will be highly individualized and tailored to unique circumstances of each patient and we expect home visits, calls, ProMobile usage and group visits to vary by patient.

Community Health Worker
usual care and health education brochures every 4 months.OTHER

Patients randomized to the control group will receive usual care.

Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age and older
  • History of an ischemic or intra-cerebral hemorrhagic stroke within the past five years
  • Be Hispanic/Latino on self report
  • modified Rankin Scale (mRs) ≤ 3
  • Reside in Miami-Dade County

You may not qualify if:

  • Any life-threatening morbidity including an active cancer diagnosis
  • Enrollment in other non acute stroke, cardiovascular, diabetes study
  • Patients with an arm circumference of ≥47 cm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Related Publications (1)

  • Carrasquillo O, Young B, Dang S, Fontan O, Ferras N, Romano JG, Dong C, Kenya S. Hispanic Secondary Stroke Prevention Initiative Design: Study Protocol and Rationale for a Randomized Controlled Trial. JMIR Res Protoc. 2018 Oct 19;7(10):e11083. doi: 10.2196/11083.

    PMID: 30341050DERIVED

MeSH Terms

Conditions

StrokeIschemic Attack, TransientHypertensionHypercholesterolemiaBehaviorMotor ActivityDiabetes Mellitus

Interventions

Community Health Workers

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain IschemiaHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Allied Health PersonnelHealth PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • Olveen Carrasquillo, MD, MPH

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Olveen Carrasquillo, MD, MPH

Study Record Dates

First Submitted

September 25, 2014

First Posted

September 29, 2014

Study Start

January 1, 2015

Primary Completion

June 18, 2019

Study Completion

June 18, 2019

Last Updated

June 20, 2019

Record last verified: 2019-06

Locations

US(1)