Hispanic Secondary Stroke Prevention Initiative

Stroke is the fourth leading cause of death, and the main cause of adult disability in the
US. As the population ages, over the next 3 decades the number of strokes is expected to
double. At the same time, the Hispanic population, currently the largest minority group in
the US is expected to double. The rapid growth and aging of Hispanics will lead to dramatic
future increases in the public health impact of stroke. This group of investigators and
others have extensively described the disproportionate burden of stroke and stroke risk
factors (SRFs) (e.g. blood pressure, diabetes, and lipids) among Hispanics. Over the last two
decades, community health workers (CHWs) have emerged as one of the more promising strategies
at addressing Latino health disparities. However, evidence from randomized controlled trials
(RCTs) supporting this approach remains limited. Recent technology based interventions,
particularly those using mobile-based platforms (e.g. phone text messaging), have shown
tremendous potential at improving outcomes among minority populations. This team's ongoing
line of investigation is testing Community Health Workers (CHWs) interventions through
rigorous randomized controlled trials (RCTs) aimed at improving clinical outcomes for a
variety of health conditions including diabetes, cancer and Human Immunodeficiency Virus
(HIV) disease. The investigators are also leading several studies addressing ProMobile
technologies among minority elders. To date, preliminary data suggests each of these two
approaches independently may lead to considerable improvements in some stroke risk factors
(SRFs). However, evidence for the use of these combined approaches from studies using
rigorous experimental designs for most health conditions has been limited. Further, data on
these promising interventions among Hispanic stroke patients remains a major gap in the field
of stroke disparities.

In the Hispanic Secondary Stroke Prevention Intervention (HISSPI),the investigators propose a
translational research study addressing minority health in the form of a pragmatic clinical
trial aimed at improving health outcomes among Latinos. The project extends their ongoing
work with Community Health Workers (CHWs) and mobile phone technologies to examine the
effectiveness of this combined multilevel intervention as an adjunct to routine health care
targeting stroke risk factors (SRFs) among Hispanic patients having had a recent stroke. The
investigators focus on this group of patients because they have an over 25% risk of recurrent
stroke in the next five years, with the second stroke often being much more debilitating than
the first stroke.

The study will be conducted at two hospitals in Miami-Dade county (one public, one private).
With a highly diverse Latino population, both Caribbean and Central/South Americans, Miami is
an ideal laboratory to test such an approach in an immigrant community facing numerous
distinct barriers to quality stroke care. Hispanic Secondary Stroke Prevention Initiative
(HISPPI) also leverages existing resources, including those of the recently funded Florida
Puerto Rico Collaboration to Reduce Stroke Disparities and the Clinical Translational Science
Award (CTSA). The investigators expect this translational research to provide new insights on
approaches that can transform medical practice and improve health outcomes in Latino
populations; particularly, in the context of ongoing reforms in health care delivery. The
study design is a randomized controlled trial (RCT) of 300 Latino stroke patients admitted
with an ischemic or hemorrhagic stroke, having a minimal to moderate disability as a result
of the stroke but whom are ambulatory modified Rankin Scale (mRS) <=3.

Primary Objectives: Based on evidence based guidelines to prevent a recurrent stroke, the
investigators will determine if the proposed intervention results in improved systolic blood
pressure among the intervention versus usual care group. Blood pressure management is the
single most important risk factor for preventing a recurrent stroke.

Secondary Objectives: The investigators will also examine if the proposed intervention
results in improvements in other secondary stroke risk factors including low density
lipoprotein, adherence to statin therapy,adherence to antiplatelet/anti-thrombotic therapy,
and among patients with diabetes, better glycemic control.

Additional outcomes: As hypothesis generating analyses, the investigators will examine, the
following outcomes:

1. Quality of Life

2. Health Care utilization (visits to primary care providers and stroke specialists)

3. Proportion of patients re-hospitalized for recurrent stroke

Hypotheses: Consistent with guidelines on systolic blood pressure (SBP) reductions that would
lead to clinically meaningful reductions in recurrent stroke risk, the investigators
hypothesize that at 12 months, as compared to usual care, patients randomized to the
Community Health Worker (CHW) ProMobile intervention will have a systolic blood pressure that
is 8mmHg lower. Least detectable differences for secondary outcomes: With 300 patients, the
investigators will have over 80% power to detect differences in intervention versus control
group of 1) Low-density lipoprotein (LDL) that is 13ml/dl lower 2) 15% greater adherence to
statin and antiplatelet/thrombotic therapy 3) among the subset having diabetes, glycated
haemoglobin (HbA1c) that is 0.9% lower.

Inclusion Criteria:

- 18 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

Exclusion Criteria:

- 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