<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/NCT03034993</url>
  </required_header>
  <id_info>
    <org_study_id>H-35967</org_study_id>
    <secondary_id>catalyst grant</secondary_id>
    <nct_id>NCT03034993</nct_id>
  </id_info>
  <brief_title>Self-Management Using Text Messaging in a Homeless Population</brief_title>
  <official_title>Improving Self-Management of Chronic Conditions Among Homeless Persons: a Community-Based Participatory Approach Using Text Messaging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Boston Health Care for the Homeless Program</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Boston University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if an automated text message intervention is&#xD;
      beneficial for homeless patients in reducing their hospital visits, increasing their primary&#xD;
      care appointments, and help them increase medication adherence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Boston Healthcare for the Homeless Program (BHCHP) is the study site for this research. It is&#xD;
      the largest freestanding health care for the homeless program in the country - it provides&#xD;
      primary care, behavioral health, oral health care and other wrap-around services to 12,500&#xD;
      homeless individuals a year. BHCHP was recently awarded a two-year grant from the&#xD;
      Massachusetts Health Policy Commission to demonstrate how intensive, coordinated case&#xD;
      management can reduce costs of caring for homeless persons who are high utilizers of&#xD;
      emergency department (ED) and inpatient care. The Social Determinants of Health Coordinated&#xD;
      Care Hub for Homeless Adults project (hereafter the &quot;Care Hub&quot;) will create capacity among 9&#xD;
      Boston organizations serving homeless residents to meet their needs in primary care,&#xD;
      behavioral health, housing, and shelter. This will improve quality of life, health outcomes,&#xD;
      and care efficiency for the organizations. The participating organizations, in addition to&#xD;
      BHCHP, are Bay Cove Human Services, Boston Public Health Commission, Boston Rescue Mission,&#xD;
      Casa Esperanza, Massachusetts Housing and Shelter Alliance, The New England Center and Home&#xD;
      for Veterans, St. Francis House, Victory Programs Specifically the investigators anticipate&#xD;
      that patients participating in the Care Hub will have reduced use of ED and inpatient care&#xD;
      because they will be better linked to and retained in appropriate care such as outpatient,&#xD;
      mental health, substance use disorder (SUD), preventive care, and respite care. Regular care&#xD;
      will increase the appropriate management of chronic health conditions and reduce episodes of&#xD;
      exacerbations of these conditions which often lead to ED and hospital care. The purpose of&#xD;
      this study is to evaluate whether an a text messaging system of appointment reminders, along&#xD;
      with medication taking messages, and text messages about mood will augment the effectiveness&#xD;
      of the Care Hub program.&#xD;
&#xD;
      The investigators propose to pilot a cell phone-based outpatient care support and medication&#xD;
      reminder system. The content will include appointment reminders and educational and&#xD;
      motivational messages about the importance of going to all outpatient care visits and of&#xD;
      taking medications. The investigators take a community-based participatory research approach&#xD;
      to this study - both because it appropriately considers the needs of the target population&#xD;
      (increasing the likelihood of success) and because it empowers a population that is often&#xD;
      treated as if its members were powerless. The cell phone texting intervention will help&#xD;
      patients stay engaged in care, adhere to their medications, and adopt and sustain behavior&#xD;
      change. This will be accomplished by completing a series of objectives:&#xD;
&#xD;
        1. To develop a text messaging system designed for homeless patients which includes&#xD;
           appointment reminders, medication taking reminders and motivation, and texts messages&#xD;
           that allow participants to report their mood, all in support of chronic disease&#xD;
           management. The system will be based on a health coaching model, and message content&#xD;
           will be reviewed and edited by patients who are members of drafted by patient members of&#xD;
           a BHCHP Community Innovation Panel (CIP).&#xD;
&#xD;
        2. To train Care Hub intervention patients (or refresh existing skills) in cell phone text&#xD;
           messaging.&#xD;
&#xD;
        3. To test the text messaging system in a randomized pilot study with 60 patients,&#xD;
           comparing outpatient, respite care, ED, and inpatient utilization, and Health-Related&#xD;
           Quality of Care (HRQOL) between the 30 intervention and 30 control patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 21, 2017</start_date>
  <completion_date type="Actual">April 30, 2019</completion_date>
  <primary_completion_date type="Actual">December 30, 2018</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Emergency Department Visits Made</measure>
    <time_frame>4 months</time_frame>
    <description>Data from BHCHP's electronic medical record (EMR) and from the Coordinated Care Hub electronic case management system in use by the Care Hub organizations, which includes admission and discharge data</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Inpatient admissions</measure>
    <time_frame>4 months</time_frame>
    <description>Similar to Emergency Department visit data, this will come from BHCHP's EMR and from the electronic case management system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Appointment keeping</measure>
    <time_frame>4 months</time_frame>
    <description>Ratio of kept appointments to all appointments scheduled, based on the BHCHP EMR (e.g. 0-100%).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication Adherence</measure>
    <time_frame>4 months</time_frame>
    <description>Self report medication adherence is assessed with 2 measures: Morisky adherence scale, (range, 0=poor to 11=excellent) and a 1-item rating question in which patients rate their ability to take all their medications as prescribed (range, 1=very poor to 6=excellent)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adult Well-Being Assessment</measure>
    <time_frame>4 months</time_frame>
    <description>This 9-item health-related quality of life (HRQOL) assessment is a validated measure developed by the Institute for Healthcare Improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comfort with Computers and Cell Phones</measure>
    <time_frame>4 months</time_frame>
    <description>The eHealth Literacy Scale, eHEALS, (range 8-40, higher equals greater self-efficacy) assesses comfort with computers and the Internet for health related purposes. Investigators will also adapt eHEALS so that separate items can be asked about comfort with cell phone use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Cell Phone Use and Computer Use</measure>
    <time_frame>4 months</time_frame>
    <description>Measures come from the Health Information National Trends Survey (HINTS). Scale ranges from 0 (no use) to 12 (frequent use of many features).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Outpatient appointments</measure>
    <time_frame>4 months</time_frame>
    <description>Number of outpatient visits made</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Chronic Disease</condition>
  <arm_group>
    <arm_group_label>Text Messaging</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will receive text messages with appointment reminders, medication taking education and motivation, and for reporting of mood.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>This group will receive simple text messages about general health promotion, such as about the importance of drinking water on hot days, using sunscreen, etc.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Text Messaging</intervention_name>
    <description>Subjects will receive text messages with reminders of their upcoming outpatient health care appointments at the Boston Health Care for the Homeless Program (BHCHP) clinic. The text message will indicate the time of the appointment and the location (e.g. &quot;Remember appointment Friday March 15 at 10am in the Yawkey building&quot;). Appointment reminder text messages will be sent 3 days ahead and again 1 day ahead of the appointment date. Medication related texts will be sent every other day and will be educational and motivational (e.g. &quot;Keep taking medications that way the doctor prescribed them, even if feeling fine&quot;). Mood related texts will also be sent every other day and ask about mood on a 1 to 5 scale. The participant will text back a response.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Text Messaging</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  is a patient participant in the Coordinated Care Hub Initiative&#xD;
&#xD;
          -  is willing to receive text messages&#xD;
&#xD;
          -  is able to understand English - spoken and read&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  has an inability to find, open, and respond to a test text message&#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>Donald K McInnes, ScD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston University and Department of Veterans Affairs</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boston University School of Public Health</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
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    <citation>Barrow SM, Herman DB, Cordova P, Struening EL. Mortality among homeless shelter residents in New York City. Am J Public Health. 1999 Apr;89(4):529-34. doi: 10.2105/ajph.89.4.529.</citation>
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  <verification_date>May 2019</verification_date>
  <study_first_submitted>January 26, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>May 1, 2019</last_update_submitted>
  <last_update_submitted_qc>May 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston University</investigator_affiliation>
    <investigator_full_name>Donald Keith McInnes</investigator_full_name>
    <investigator_title>Research Assistant Professor, BUSPH</investigator_title>
  </responsible_party>
  <keyword>Healthcare for homeless</keyword>
  <keyword>Text messages</keyword>
  <keyword>Primary care visits</keyword>
  <keyword>Medication adherence</keyword>
  <keyword>Inpatient admissions</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03034993
org study id: H-35967
secondary id: catalyst grant
nct id: NCT03034993
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine if an automated text message intervention is
      beneficial for homeless patients in reducing their hospital visits, increasing their primary
      care appointments, and help them increase medication adherence.
Boston Healthcare for the Homeless Program (BHCHP) is the study site for this research. It is
      the largest freestanding health care for the homeless program in the country - it provides
      primary care, behavioral health, oral health care and other wrap-around services to 12,500
      homeless individuals a year. BHCHP was recently awarded a two-year grant from the
      Massachusetts Health Policy Commission to demonstrate how intensive, coordinated case
      management can reduce costs of caring for homeless persons who are high utilizers of
      emergency department (ED) and inpatient care. The Social Determinants of Health Coordinated
      Care Hub for Homeless Adults project (hereafter the "Care Hub") will create capacity among 9
      Boston organizations serving homeless residents to meet their needs in primary care,
      behavioral health, housing, and shelter. This will improve quality of life, health outcomes,
      and care efficiency for the organizations. The participating organizations, in addition to
      BHCHP, are Bay Cove Human Services, Boston Public Health Commission, Boston Rescue Mission,
      Casa Esperanza, Massachusetts Housing and Shelter Alliance, The New England Center and Home
      for Veterans, St. Francis House, Victory Programs Specifically the investigators anticipate
      that patients participating in the Care Hub will have reduced use of ED and inpatient care
      because they will be better linked to and retained in appropriate care such as outpatient,
      mental health, substance use disorder (SUD), preventive care, and respite care. Regular care
      will increase the appropriate management of chronic health conditions and reduce episodes of
      exacerbations of these conditions which often lead to ED and hospital care. The purpose of
      this study is to evaluate whether an a text messaging system of appointment reminders, along
      with medication taking messages, and text messages about mood will augment the effectiveness
      of the Care Hub program.

      The investigators propose to pilot a cell phone-based outpatient care support and medication
      reminder system. The content will include appointment reminders and educational and
      motivational messages about the importance of going to all outpatient care visits and of
      taking medications. The investigators take a community-based participatory research approach
      to this study - both because it appropriately considers the needs of the target population
      (increasing the likelihood of success) and because it empowers a population that is often
      treated as if its members were powerless. The cell phone texting intervention will help
      patients stay engaged in care, adhere to their medications, and adopt and sustain behavior
      change. This will be accomplished by completing a series of objectives:

        1. To develop a text messaging system designed for homeless patients which includes
           appointment reminders, medication taking reminders and motivation, and texts messages
           that allow participants to report their mood, all in support of chronic disease
           management. The system will be based on a health coaching model, and message content
           will be reviewed and edited by patients who are members of drafted by patient members of
           a BHCHP Community Innovation Panel (CIP).

        2. To train Care Hub intervention patients (or refresh existing skills) in cell phone text
           messaging.

        3. To test the text messaging system in a randomized pilot study with 60 patients,
           comparing outpatient, respite care, ED, and inpatient utilization, and Health-Related
           Quality of Care (HRQOL) between the 30 intervention and 30 control patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Emergency Department Visits Made
time frame: 4 months
description: Data from BHCHP's electronic medical record (EMR) and from the Coordinated Care Hub electronic case management system in use by the Care Hub organizations, which includes admission and discharge data
measure: Inpatient admissions
time frame: 4 months
description: Similar to Emergency Department visit data, this will come from BHCHP's EMR and from the electronic case management system
measure: Appointment keeping
time frame: 4 months
description: Ratio of kept appointments to all appointments scheduled, based on the BHCHP EMR (e.g. 0-100%).
measure: Medication Adherence
time frame: 4 months
description: Self report medication adherence is assessed with 2 measures: Morisky adherence scale, (range, 0=poor to 11=excellent) and a 1-item rating question in which patients rate their ability to take all their medications as prescribed (range, 1=very poor to 6=excellent)
measure: Adult Well-Being Assessment
time frame: 4 months
description: This 9-item health-related quality of life (HRQOL) assessment is a validated measure developed by the Institute for Healthcare Improvement.
measure: Comfort with Computers and Cell Phones
time frame: 4 months
description: The eHealth Literacy Scale, eHEALS, (range 8-40, higher equals greater self-efficacy) assesses comfort with computers and the Internet for health related purposes. Investigators will also adapt eHEALS so that separate items can be asked about comfort with cell phone use.
measure: Frequency of Cell Phone Use and Computer Use
time frame: 4 months
description: Measures come from the Health Information National Trends Survey (HINTS). Scale ranges from 0 (no use) to 12 (frequent use of many features).
measure: Outpatient appointments
time frame: 4 months
description: Number of outpatient visits made
arm group label: Text Messaging
arm group type: Experimental
description: This group will receive text messages with appointment reminders, medication taking education and motivation, and for reporting of mood.
arm group label: Control
arm group type: Placebo Comparator
description: This group will receive simple text messages about general health promotion, such as about the importance of drinking water on hot days, using sunscreen, etc.
intervention type: Behavioral
intervention name: Text Messaging
description: Subjects will receive text messages with reminders of their upcoming outpatient health care appointments at the Boston Health Care for the Homeless Program (BHCHP) clinic. The text message will indicate the time of the appointment and the location (e.g. "Remember appointment Friday March 15 at 10am in the Yawkey building"). Appointment reminder text messages will be sent 3 days ahead and again 1 day ahead of the appointment date. Medication related texts will be sent every other day and will be educational and motivational (e.g. "Keep taking medications that way the doctor prescribed them, even if feeling fine"). Mood related texts will also be sent every other day and ask about mood on a 1 to 5 scale. The participant will text back a response.
arm group label: Control
arm group label: Text Messaging
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Donald K McInnes, ScD
role: Principal Investigator
affiliation: Boston University and Department of Veterans Affairs
facility: 
country: United States
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responsible party type: Principal Investigator
investigator affiliation: Boston University
investigator full name: Donald Keith McInnes
investigator title: Research Assistant Professor, BUSPH
mesh term: Chronic Disease
sharing ipd: No