<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02251834</url>
  </required_header>
  <id_info>
    <org_study_id>20140423</org_study_id>
    <secondary_id>R01MD009164</secondary_id>
    <nct_id>NCT02251834</nct_id>
  </id_info>
  <brief_title>Hispanic Secondary Stroke Prevention Initiative</brief_title>
  <acronym>HISSPI</acronym>
  <official_title>Hispanic Secondary Stroke Prevention Initiative</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Minority Health and Health Disparities (NIMHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Miami</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Stroke is a leading cause of death and functional impairments and stroke risk factors (SRFs)&#xD;
      disproportionately affect Latino populations. In the Hispanic Secondary Stroke Prevention&#xD;
      Initiative (HISSPI) the investigators propose a study using Community Health Workers (CHW)&#xD;
      and mobile technologies using cell phones to reduce the risk for a recurrent stroke among&#xD;
      Latino stroke patients.&#xD;
&#xD;
      The project examines the effectiveness of a combined multilevel intervention consisting of&#xD;
      Community Health Workers (CHW) and mobile based phone technologies in lowering of systolic&#xD;
      blood pressure (SBP) which is the most important risk factor for recurrent stroke.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Stroke is the fourth leading cause of death, and the main cause of adult disability in the&#xD;
      US. As the population ages, over the next 3 decades the number of strokes is expected to&#xD;
      double. At the same time, the Hispanic population, currently the largest minority group in&#xD;
      the US is expected to double. The rapid growth and aging of Hispanics will lead to dramatic&#xD;
      future increases in the public health impact of stroke. This group of investigators and&#xD;
      others have extensively described the disproportionate burden of stroke and stroke risk&#xD;
      factors (SRFs) (e.g. blood pressure, diabetes, and lipids) among Hispanics. Over the last two&#xD;
      decades, community health workers (CHWs) have emerged as one of the more promising strategies&#xD;
      at addressing Latino health disparities. However, evidence from randomized controlled trials&#xD;
      (RCTs) supporting this approach remains limited. Recent technology based interventions,&#xD;
      particularly those using mobile-based platforms (e.g. phone text messaging), have shown&#xD;
      tremendous potential at improving outcomes among minority populations. This team's ongoing&#xD;
      line of investigation is testing Community Health Workers (CHWs) interventions through&#xD;
      rigorous randomized controlled trials (RCTs) aimed at improving clinical outcomes for a&#xD;
      variety of health conditions including diabetes, cancer and Human Immunodeficiency Virus&#xD;
      (HIV) disease. The investigators are also leading several studies addressing ProMobile&#xD;
      technologies among minority elders. To date, preliminary data suggests each of these two&#xD;
      approaches independently may lead to considerable improvements in some stroke risk factors&#xD;
      (SRFs). However, evidence for the use of these combined approaches from studies using&#xD;
      rigorous experimental designs for most health conditions has been limited. Further, data on&#xD;
      these promising interventions among Hispanic stroke patients remains a major gap in the field&#xD;
      of stroke disparities.&#xD;
&#xD;
      In the Hispanic Secondary Stroke Prevention Intervention (HISSPI),the investigators propose a&#xD;
      translational research study addressing minority health in the form of a pragmatic clinical&#xD;
      trial aimed at improving health outcomes among Latinos. The project extends their ongoing&#xD;
      work with Community Health Workers (CHWs) and mobile phone technologies to examine the&#xD;
      effectiveness of this combined multilevel intervention as an adjunct to routine health care&#xD;
      targeting stroke risk factors (SRFs) among Hispanic patients having had a recent stroke. The&#xD;
      investigators focus on this group of patients because they have an over 25% risk of recurrent&#xD;
      stroke in the next five years, with the second stroke often being much more debilitating than&#xD;
      the first stroke.&#xD;
&#xD;
      The study will be conducted at two hospitals in Miami-Dade county (one public, one private).&#xD;
      With a highly diverse Latino population, both Caribbean and Central/South Americans, Miami is&#xD;
      an ideal laboratory to test such an approach in an immigrant community facing numerous&#xD;
      distinct barriers to quality stroke care. Hispanic Secondary Stroke Prevention Initiative&#xD;
      (HISPPI) also leverages existing resources, including those of the recently funded Florida&#xD;
      Puerto Rico Collaboration to Reduce Stroke Disparities and the Clinical Translational Science&#xD;
      Award (CTSA). The investigators expect this translational research to provide new insights on&#xD;
      approaches that can transform medical practice and improve health outcomes in Latino&#xD;
      populations; particularly, in the context of ongoing reforms in health care delivery. The&#xD;
      study design is a randomized controlled trial (RCT) of 300 Latino stroke patients admitted&#xD;
      with an ischemic or hemorrhagic stroke, having a minimal to moderate disability as a result&#xD;
      of the stroke but whom are ambulatory modified Rankin Scale (mRS) &lt;=3.&#xD;
&#xD;
      Primary Objectives: Based on evidence based guidelines to prevent a recurrent stroke, the&#xD;
      investigators will determine if the proposed intervention results in improved systolic blood&#xD;
      pressure among the intervention versus usual care group. Blood pressure management is the&#xD;
      single most important risk factor for preventing a recurrent stroke.&#xD;
&#xD;
      Secondary Objectives: The investigators will also examine if the proposed intervention&#xD;
      results in improvements in other secondary stroke risk factors including low density&#xD;
      lipoprotein, adherence to statin therapy,adherence to antiplatelet/anti-thrombotic therapy,&#xD;
      and among patients with diabetes, better glycemic control.&#xD;
&#xD;
      Additional outcomes: As hypothesis generating analyses, the investigators will examine, the&#xD;
      following outcomes:&#xD;
&#xD;
        1. Quality of Life&#xD;
&#xD;
        2. Health Care utilization (visits to primary care providers and stroke specialists)&#xD;
&#xD;
        3. Proportion of patients re-hospitalized for recurrent stroke&#xD;
&#xD;
      Hypotheses: Consistent with guidelines on systolic blood pressure (SBP) reductions that would&#xD;
      lead to clinically meaningful reductions in recurrent stroke risk, the investigators&#xD;
      hypothesize that at 12 months, as compared to usual care, patients randomized to the&#xD;
      Community Health Worker (CHW) ProMobile intervention will have a systolic blood pressure that&#xD;
      is 8mmHg lower. Least detectable differences for secondary outcomes: With 300 patients, the&#xD;
      investigators will have over 80% power to detect differences in intervention versus control&#xD;
      group of 1) Low-density lipoprotein (LDL) that is 13ml/dl lower 2) 15% greater adherence to&#xD;
      statin and antiplatelet/thrombotic therapy 3) among the subset having diabetes, glycated&#xD;
      haemoglobin (HbA1c) that is 0.9% lower.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2015</start_date>
  <completion_date type="Actual">June 18, 2019</completion_date>
  <primary_completion_date type="Actual">June 18, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood Pressure</measure>
    <time_frame>one year</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>LDL</measure>
    <time_frame>one year</time_frame>
    <description>Achieving an LDL-C level of 70 mg/dL is associated with a 28% stroke risk reduction and stroke patients with a 50% reduction in LDL-C had a 35% reduction in combined risk of nonfatal and fatal stroke.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported adherence to statins and anti-platelet medications</measure>
    <time_frame>one year</time_frame>
    <description>Morisky medication adherence scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>A1C</measure>
    <time_frame>one year</time_frame>
    <description>among patients having diabetes we will measure A1C</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Community Health Worker</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Community Health Worker (CHW) home visits, coaching phone calls, group sessions .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>usual care and health education brochures every 4 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Community Health Worker (CHW)</intervention_name>
    <description>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.</description>
    <arm_group_label>Community Health Worker</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>usual care and health education brochures every 4 months.</intervention_name>
    <description>Patients randomized to the control group will receive usual care.</description>
    <arm_group_label>Usual Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age and older&#xD;
&#xD;
          -  History of an ischemic or intra-cerebral hemorrhagic stroke within the past five years&#xD;
&#xD;
          -  Be Hispanic/Latino on self report&#xD;
&#xD;
          -  modified Rankin Scale (mRs) ≤ 3&#xD;
&#xD;
          -  Reside in Miami-Dade County&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any life-threatening morbidity including an active cancer diagnosis&#xD;
&#xD;
          -  Enrollment in other non acute stroke, cardiovascular, diabetes study&#xD;
&#xD;
          -  Patients with an arm circumference of ≥47 cm&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Olveen Carrasquillo, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Miami</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 29, 2014</study_first_posted>
  <last_update_submitted>June 18, 2019</last_update_submitted>
  <last_update_submitted_qc>June 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>Olveen Carrasquillo</investigator_full_name>
    <investigator_title>Olveen Carrasquillo, MD, MPH</investigator_title>
  </responsible_party>
  <keyword>Healthcare Disparities</keyword>
  <keyword>stroke</keyword>
  <keyword>Hispanic Americans</keyword>
  <keyword>community health worker</keyword>
  <keyword>Mobile Health</keyword>
  <keyword>Transient Ischemic Attack (TIA)</keyword>
  <keyword>hypertension</keyword>
  <keyword>Randomized Controlled Trial</keyword>
  <keyword>high cholesterol</keyword>
  <keyword>behavioral</keyword>
  <keyword>exercise</keyword>
  <keyword>diabetes</keyword>
  <keyword>diet</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02251834
org study id: 20140423
secondary id: R01MD009164
nct id: NCT02251834
lead sponsor: 
collaborator: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Investigator)
measure: Blood Pressure
time frame: one year
description: 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.
measure: LDL
time frame: one year
description: Achieving an LDL-C level of 70 mg/dL is associated with a 28% stroke risk reduction and stroke patients with a 50% reduction in LDL-C had a 35% reduction in combined risk of nonfatal and fatal stroke.
measure: Self-reported adherence to statins and anti-platelet medications
time frame: one year
description: Morisky medication adherence scale
measure: A1C
time frame: one year
description: among patients having diabetes we will measure A1C
arm group label: Community Health Worker
arm group type: Experimental
description: Community Health Worker (CHW) home visits, coaching phone calls, group sessions .
arm group label: Usual Care
arm group type: Other
description: usual care and health education brochures every 4 months.
intervention type: Behavioral
intervention name: Community Health Worker (CHW)
description: 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.
arm group label: Community Health Worker
intervention type: Other
intervention name: usual care and health education brochures every 4 months.
description: Patients randomized to the control group will receive usual care.
arm group label: Usual Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Olveen Carrasquillo, MD, MPH
role: Principal Investigator
affiliation: University of Miami
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Miami
investigator full name: Olveen Carrasquillo
investigator title: Olveen Carrasquillo, MD, MPH
mesh term: Stroke