<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/NCT03787485</url>
  </required_header>
  <id_info>
    <org_study_id>1612044741R001</org_study_id>
    <nct_id>NCT03787485</nct_id>
  </id_info>
  <brief_title>Linking Individual Needs to Community and Clinical Services</brief_title>
  <acronym>LINKS</acronym>
  <official_title>Linking Individual Needs to Community and Clinical Services</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abby Lohr</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pima County Health Department</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Yuma County Health District</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>El Rio Community Health Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sunset Community Health Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mariposa Community Health Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Arizona Community Health Outreach Workers Association (AzCHOW)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Arizona</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>
      For 15 years, the Centers for Disease Control and Prevention (CDC)-funded Arizona Prevention&#xD;
      Research Center (AzPRC) has been engaged in academic community collaborative research to&#xD;
      reduce chronic disease health disparities among the Latino border communities in Arizona,&#xD;
      which positions the center well to contribute to CDC's current winnable battle of nutrition,&#xD;
      physical activity and obesity. The AzPRC's research study Linking Individual Needs to&#xD;
      Community and Clinical Services (LINKS) will implement and evaluate a CHW-delivered&#xD;
      preventive program linking primary care settings dedicated to reaching the under-served with&#xD;
      community services that are county-delivered or -based. By developing community-clinical&#xD;
      linkages, the AzPRC will help ensure access to, and quality of, culturally relevant&#xD;
      prevention and promotion efforts. These efforts will result in a sustainable and scalable CHW&#xD;
      model program that reduces obesity and associated chronic disease, and improves overall&#xD;
      health in under-served communities at the Arizona U.S.-Mexico border.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Over the past 15 years, CDC-funded AzPRC researchers have strengthened collaborations with&#xD;
      community partners while developing and implementing comprehensive diabetes prevention and&#xD;
      control programs (1998-2019), and policy intervention research (2009-2014) in Southern&#xD;
      Arizona border communities. The community health worker (CHW)-led diabetes programs were&#xD;
      successful in terms of community perception and health improvements. Despite this success,&#xD;
      disparities in chronic disease remained unacceptably high. The investigators developed and&#xD;
      implemented an innovative intervention research project, Acción Para La Salud (Acción), which&#xD;
      engaged CHWs in community-level advocacy to empower border communities to address root causes&#xD;
      of chronic disease. This community-based participatory research (CBPR) project recognized the&#xD;
      importance of addressing the social determinants of health to overcome health disparities in&#xD;
      chronic disease. The investigators have published results and processes of Acción.&#xD;
&#xD;
      Chronic disease and obesity health disparities continue to disproportionately affect Hispanic&#xD;
      populations along the U.S. Mexico border in part due to barriers to healthful nutrition,&#xD;
      adequate physical activity, and mental/emotional well-being as well as insufficient access to&#xD;
      culturally appropriate health care services. In collaboration with our border-wide Community&#xD;
      Action Board (CAB), the investigators are taking our intervention expertise one step further&#xD;
      by developing and testing novel CHW-led interventions that will link community and clinical&#xD;
      services.&#xD;
&#xD;
      In recent years, federally qualified community health centers (FQHCs), a major backbone of&#xD;
      the primary care system in reaching under-served populations across the US, have begun to&#xD;
      involve the CHW model into various services, often with a focus on chronic disease prevention&#xD;
      and control. While CHWs help improve the quality and cultural relevancy of health care,&#xD;
      improve patient centered care, and improve linkages between primary care and community&#xD;
      services, each clinic adapts practices within their clinic environment without clear&#xD;
      guidelines about best practices, or concrete evidence regarding activities best shown to lead&#xD;
      to improvement in health outcomes. In addition, there may not be clear linkages from the&#xD;
      clinic to CHW programs in the community that have been shown to be effective in chronic&#xD;
      disease control and prevention, and there are challenges in identifying mechanisms for the&#xD;
      sustainability of effective clinical or community programs. Our intervention research&#xD;
      proposes to fill these gaps by establishing clear guidance and best practices for CHW&#xD;
      involvement in primary care and community settings to prevent and manage chronic disease, and&#xD;
      to promote mental/emotional well-being.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 14, 2017</start_date>
  <completion_date type="Actual">September 30, 2019</completion_date>
  <primary_completion_date type="Actual">April 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change from past (three years to baseline) participant glycosylated hemoglobin on the A1c test reported in electronic medical record after initiation of intervention</measure>
    <time_frame>July 14, 2014- June 30, 2019</time_frame>
    <description>Glycosylated hemoglobin (mmol/mol) will be extracted from laboratory reports reported in the electronic medical record.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from past (three years to baseline) participant body mass index (BMI) calculated from height (meters) and weight in (kilograms) reported in electronic medical record after initiation of intervention</measure>
    <time_frame>July 14, 2014- June 30, 2019</time_frame>
    <description>Height and weight reported in the participant's electronic medical record will be combined to report BMI in kg/m^2.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from past (three years to baseline) participant blood pressure based on systolic and diastolic blood pressures reported in electronic medical record after initiation of intervention</measure>
    <time_frame>July 14, 2014- June 30, 2019</time_frame>
    <description>Systolic and diastolic blood pressure (mmHg) will be extracted from vitals reported in the participant's electronic medical record.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from past (three years to baseline) participant total cholesterol as measured by low-density lipoprotein (LDL), high-density lipoprotein (HDL), and triglycerides reported in electronic medical record after initiation of intervention</measure>
    <time_frame>July 14, 2014- June 30, 2019</time_frame>
    <description>LDL, HDL, and triglycerides (mg/dL) reported in the participant's electronic medical record will be combined to report total cholesterol (mg/dL).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in participant self-rated health, emotional well-being, and life satisfaction on 3 questions from the Behavioral Risk Factor Surveillance System (BRFSS) at 3 and 6 months</measure>
    <time_frame>July 14, 2017-March 30, 2019</time_frame>
    <description>The investigators will ask three questions from the BRFSS:&#xD;
Would you say in general your health is: (Excellent / Very good / Good / Fair / Poor)&#xD;
How often do you get the social and emotional support you need? (Always / Usually / Sometimes / Rarely / Never)&#xD;
In general, how satisfied are you with your life? (Very satisfied / Satisfied / Dissatisfied / Very Dissatisfied)&#xD;
Responses from the BRFSS are Likert type questions. Individual items from the scales will be tabulated and summarized at each administration of the questionnaire. The outcome at each timepoint for a given subject on a given scale will be the sum of the scores of the items from that scale. An increase in the score demonstrates a positive outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in participant physical activity frequency in the last week on 1 question physical activity question at 3 and 6 months</measure>
    <time_frame>July 14, 2017-March 30, 2019</time_frame>
    <description>To determine participant physical activity, the investigators will ask a single question regarding the amount of physical activity the subject engaged in during the previous week:&#xD;
In the past week, on how many days have you done a total of 30 minutes or more of physical activity, which was enough to raise your breathing rate? (0-7 days)&#xD;
An increase in days reported demonstrates a positive outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in participant mental and physical health on Short Form 8 Health Assessment (SF8) at 3 and 6 months</measure>
    <time_frame>July 14, 2017-September 30, 2019</time_frame>
    <description>Responses from the SF8 are Likert type questions. Individual items from this scale will be tabulated and summarized at each administration of the questionnaire. The outcome at each timepoint for a given subject on a given scale will be the sum of the scores of the items from that scale. An increase in the score demonstrates a positive outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in participant social support on the Social Support Inventory (Enhancing Recovery in Coronary Heart Disease, ENRICHED) (SSI) at 3 and 6 months</measure>
    <time_frame>July 14, 2017-September 30, 2019</time_frame>
    <description>Responses from the SSI scales are Likert type questions, with the exception of SSI question 7 (Are you currently married or living with a partner? Yes/No). Individual items from this scale will be tabulated and summarized at each administration of the questionnaire. The outcome at each timepoint for a given subject on a given scale will be the sum of the scores of the items from that scale (excluding SSI question 7). An increase in the score demonstrates a positive outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in participant hope on the State Hope Scale (SHS) at 3 and 6 months</measure>
    <time_frame>July 14, 2017-September 30, 2019</time_frame>
    <description>A total score for the SHS can be obtained by adding the values of the responses to each item, yielding a score from 6 - 48. An increase in the score demonstrates a positive outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in participant depression on the Center for Epidemiologic Studies Depression Scale (CES-D-R 10) at 3 and 6 months</measure>
    <time_frame>July 14, 2017-September 30, 2019</time_frame>
    <description>A total score for the CES-D-R 10 scale is found by determining the sum of the items which are scored as:&#xD;
Rarely or none of the time (less than 1 day); Some or a little of the time (1 - 2 days); Occasionally or a moderate amount of time (3 - 4 days); All of the time (5 - 7 days)&#xD;
Questions 5 &amp; 8: Rarely or none of the time (less than 1 day) = 3 to All of the time (5 - 7 days) = 0&#xD;
All other questions: Rarely or none of the time (less than 1 day) = 0 to All of the time (5 - 7 days) = 3&#xD;
An increase in the score demonstrates a positive outcome.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">189</enrollment>
  <condition>Chronic Disease</condition>
  <arm_group>
    <arm_group_label>LINKS Participants</arm_group_label>
    <description>Study participants who took part in the LINKS intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Electronic Medical Record Controls</arm_group_label>
    <description>The principal analytical strategy is propensity score matching, which will lead to the generation of a natural control group from the health centers existing electronic medical records. Propensity matching is highly effective in addressing selection bias of known confounders and enables causal inferences when randomization is not possible, feasible or appropriate, by creating matched groups with similar covariate distributions. Matched controls will be extracted from the electronic medical record from the participating clinics.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>LINKS</intervention_name>
    <description>The primary aim of LINKS is to create community-clinical linkages between three community health centers and their respective county health departments in southern Arizona. This study will also develop and evaluate a chronic disease and emotional well-being intervention that will connect clinic patients to community-centered, county-delivered, community health worker programs.</description>
    <arm_group_label>LINKS Participants</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All participants will be adults (21 and older), among whom approximately 70% are expected&#xD;
        to be women, and the majority (at least 60%) to be Hispanic.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants who have pre-diabetes, glucose intolerance or diabetes, and/or&#xD;
             hypertension, and/or high cholesterol&#xD;
&#xD;
          -  Participants not receiving palliative care;&#xD;
&#xD;
          -  Participants without a history of serious mental illness (SMI)&#xD;
&#xD;
          -  Participants who are not pregnant;&#xD;
&#xD;
          -  Participants who speak either English or Spanish;&#xD;
&#xD;
          -  Participants who are geographically close to the community based site; and&#xD;
&#xD;
          -  Participants who consent to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants who do not consent to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Scott C Carvajal, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Arizona Prevention Research Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mariposa Community Health Center</name>
      <address>
        <city>Nogales</city>
        <state>Arizona</state>
        <zip>85621</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>El Rio Community Health Center</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85714</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pima County Health Department</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85714</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunset Community Health Center</name>
      <address>
        <city>Yuma</city>
        <state>Arizona</state>
        <zip>85364</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yuma County Health District</name>
      <address>
        <city>Yuma</city>
        <state>Arizona</state>
        <zip>85364</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Lohr AM, Ingram M, Nunez AV, Reinschmidt KM, Carvajal SC. Community-Clinical Linkages With Community Health Workers in the United States: A Scoping Review. Health Promot Pract. 2018 May;19(3):349-360. doi: 10.1177/1524839918754868. Epub 2018 Jan 24.</citation>
    <PMID>29363334</PMID>
  </reference>
  <reference>
    <citation>Ingram M, Doubleday K, Bell ML, Lohr A, Murrieta L, Velasco M, Blackburn J, Sabo S, Guernsey de Zapien J, Carvajal SC. Community Health Worker Impact on Chronic Disease Outcomes Within Primary Care Examined Using Electronic Health Records. Am J Public Health. 2017 Oct;107(10):1668-1674. doi: 10.2105/AJPH.2017.303934. Epub 2017 Aug 17.</citation>
    <PMID>28817321</PMID>
  </reference>
  <reference>
    <citation>Reinschmidt KM, Ingram M, Morales S, Sabo SJ, Blackburn J, Murrieta L, David C, Carvajal SC. Documenting Community Health Worker Roles in Primary Care: Contributions to Evidence-Based Integration Into Health Care Teams, 2015. J Ambul Care Manage. 2017 Oct/Dec;40(4):305-315. doi: 10.1097/JAC.0000000000000178.</citation>
    <PMID>28350634</PMID>
  </reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>March 24, 2020</last_update_submitted>
  <last_update_submitted_qc>March 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Arizona</investigator_affiliation>
    <investigator_full_name>Abby Lohr</investigator_full_name>
    <investigator_title>Senior Research Specialist</investigator_title>
  </responsible_party>
  <keyword>Community Health Worker</keyword>
  <keyword>Community Clinical Linkage</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/NCT03787485
org study id: 1612044741R001
nct id: NCT03787485
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
For 15 years, the Centers for Disease Control and Prevention (CDC)-funded Arizona Prevention
      Research Center (AzPRC) has been engaged in academic community collaborative research to
      reduce chronic disease health disparities among the Latino border communities in Arizona,
      which positions the center well to contribute to CDC's current winnable battle of nutrition,
      physical activity and obesity. The AzPRC's research study Linking Individual Needs to
      Community and Clinical Services (LINKS) will implement and evaluate a CHW-delivered
      preventive program linking primary care settings dedicated to reaching the under-served with
      community services that are county-delivered or -based. By developing community-clinical
      linkages, the AzPRC will help ensure access to, and quality of, culturally relevant
      prevention and promotion efforts. These efforts will result in a sustainable and scalable CHW
      model program that reduces obesity and associated chronic disease, and improves overall
      health in under-served communities at the Arizona U.S.-Mexico border.
Over the past 15 years, CDC-funded AzPRC researchers have strengthened collaborations with
      community partners while developing and implementing comprehensive diabetes prevention and
      control programs (1998-2019), and policy intervention research (2009-2014) in Southern
      Arizona border communities. The community health worker (CHW)-led diabetes programs were
      successful in terms of community perception and health improvements. Despite this success,
      disparities in chronic disease remained unacceptably high. The investigators developed and
      implemented an innovative intervention research project, Acción Para La Salud (Acción), which
      engaged CHWs in community-level advocacy to empower border communities to address root causes
      of chronic disease. This community-based participatory research (CBPR) project recognized the
      importance of addressing the social determinants of health to overcome health disparities in
      chronic disease. The investigators have published results and processes of Acción.

      Chronic disease and obesity health disparities continue to disproportionately affect Hispanic
      populations along the U.S. Mexico border in part due to barriers to healthful nutrition,
      adequate physical activity, and mental/emotional well-being as well as insufficient access to
      culturally appropriate health care services. In collaboration with our border-wide Community
      Action Board (CAB), the investigators are taking our intervention expertise one step further
      by developing and testing novel CHW-led interventions that will link community and clinical
      services.

      In recent years, federally qualified community health centers (FQHCs), a major backbone of
      the primary care system in reaching under-served populations across the US, have begun to
      involve the CHW model into various services, often with a focus on chronic disease prevention
      and control. While CHWs help improve the quality and cultural relevancy of health care,
      improve patient centered care, and improve linkages between primary care and community
      services, each clinic adapts practices within their clinic environment without clear
      guidelines about best practices, or concrete evidence regarding activities best shown to lead
      to improvement in health outcomes. In addition, there may not be clear linkages from the
      clinic to CHW programs in the community that have been shown to be effective in chronic
      disease control and prevention, and there are challenges in identifying mechanisms for the
      sustainability of effective clinical or community programs. Our intervention research
      proposes to fill these gaps by establishing clear guidance and best practices for CHW
      involvement in primary care and community settings to prevent and manage chronic disease, and
      to promote mental/emotional well-being.
observational model: Case-Control
time perspective: Prospective
measure: Change from past (three years to baseline) participant glycosylated hemoglobin on the A1c test reported in electronic medical record after initiation of intervention
time frame: July 14, 2014- June 30, 2019
description: Glycosylated hemoglobin (mmol/mol) will be extracted from laboratory reports reported in the electronic medical record.
measure: Change from past (three years to baseline) participant body mass index (BMI) calculated from height (meters) and weight in (kilograms) reported in electronic medical record after initiation of intervention
time frame: July 14, 2014- June 30, 2019
description: Height and weight reported in the participant's electronic medical record will be combined to report BMI in kg/m^2.
measure: Change from past (three years to baseline) participant blood pressure based on systolic and diastolic blood pressures reported in electronic medical record after initiation of intervention
time frame: July 14, 2014- June 30, 2019
description: Systolic and diastolic blood pressure (mmHg) will be extracted from vitals reported in the participant's electronic medical record.
measure: Change from past (three years to baseline) participant total cholesterol as measured by low-density lipoprotein (LDL), high-density lipoprotein (HDL), and triglycerides reported in electronic medical record after initiation of intervention
time frame: July 14, 2014- June 30, 2019
description: LDL, HDL, and triglycerides (mg/dL) reported in the participant's electronic medical record will be combined to report total cholesterol (mg/dL).
measure: Change from baseline in participant self-rated health, emotional well-being, and life satisfaction on 3 questions from the Behavioral Risk Factor Surveillance System (BRFSS) at 3 and 6 months
time frame: July 14, 2017-March 30, 2019
description: The investigators will ask three questions from the BRFSS:
Would you say in general your health is: (Excellent / Very good / Good / Fair / Poor)
How often do you get the social and emotional support you need? (Always / Usually / Sometimes / Rarely / Never)
In general, how satisfied are you with your life? (Very satisfied / Satisfied / Dissatisfied / Very Dissatisfied)
Responses from the BRFSS are Likert type questions. Individual items from the scales will be tabulated and summarized at each administration of the questionnaire. The outcome at each timepoint for a given subject on a given scale will be the sum of the scores of the items from that scale. An increase in the score demonstrates a positive outcome.
measure: Change from baseline in participant physical activity frequency in the last week on 1 question physical activity question at 3 and 6 months
time frame: July 14, 2017-March 30, 2019
description: To determine participant physical activity, the investigators will ask a single question regarding the amount of physical activity the subject engaged in during the previous week:
In the past week, on how many days have you done a total of 30 minutes or more of physical activity, which was enough to raise your breathing rate? (0-7 days)
An increase in days reported demonstrates a positive outcome.
measure: Change from baseline in participant mental and physical health on Short Form 8 Health Assessment (SF8) at 3 and 6 months
time frame: July 14, 2017-September 30, 2019
description: Responses from the SF8 are Likert type questions. Individual items from this scale will be tabulated and summarized at each administration of the questionnaire. The outcome at each timepoint for a given subject on a given scale will be the sum of the scores of the items from that scale. An increase in the score demonstrates a positive outcome.
measure: Change from baseline in participant social support on the Social Support Inventory (Enhancing Recovery in Coronary Heart Disease, ENRICHED) (SSI) at 3 and 6 months
time frame: July 14, 2017-September 30, 2019
description: Responses from the SSI scales are Likert type questions, with the exception of SSI question 7 (Are you currently married or living with a partner? Yes/No). Individual items from this scale will be tabulated and summarized at each administration of the questionnaire. The outcome at each timepoint for a given subject on a given scale will be the sum of the scores of the items from that scale (excluding SSI question 7). An increase in the score demonstrates a positive outcome.
measure: Change from baseline in participant hope on the State Hope Scale (SHS) at 3 and 6 months
time frame: July 14, 2017-September 30, 2019
description: A total score for the SHS can be obtained by adding the values of the responses to each item, yielding a score from 6 - 48. An increase in the score demonstrates a positive outcome.
measure: Change from baseline in participant depression on the Center for Epidemiologic Studies Depression Scale (CES-D-R 10) at 3 and 6 months
time frame: July 14, 2017-September 30, 2019
description: A total score for the CES-D-R 10 scale is found by determining the sum of the items which are scored as:
Rarely or none of the time (less than 1 day); Some or a little of the time (1 - 2 days); Occasionally or a moderate amount of time (3 - 4 days); All of the time (5 - 7 days)
Questions 5 & 8: Rarely or none of the time (less than 1 day) = 3 to All of the time (5 - 7 days) = 0
All other questions: Rarely or none of the time (less than 1 day) = 0 to All of the time (5 - 7 days) = 3
An increase in the score demonstrates a positive outcome.
arm group label: LINKS Participants
description: Study participants who took part in the LINKS intervention.
arm group label: Electronic Medical Record Controls
description: The principal analytical strategy is propensity score matching, which will lead to the generation of a natural control group from the health centers existing electronic medical records. Propensity matching is highly effective in addressing selection bias of known confounders and enables causal inferences when randomization is not possible, feasible or appropriate, by creating matched groups with similar covariate distributions. Matched controls will be extracted from the electronic medical record from the participating clinics.
intervention type: Behavioral
intervention name: LINKS
description: The primary aim of LINKS is to create community-clinical linkages between three community health centers and their respective county health departments in southern Arizona. This study will also develop and evaluate a chronic disease and emotional well-being intervention that will connect clinic patients to community-centered, county-delivered, community health worker programs.
arm group label: LINKS Participants
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Scott C Carvajal, PhD, MPH
role: Principal Investigator
affiliation: University of Arizona Prevention Research Center
facility: 
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country: United States
citation: Lohr AM, Ingram M, Nunez AV, Reinschmidt KM, Carvajal SC. Community-Clinical Linkages With Community Health Workers in the United States: A Scoping Review. Health Promot Pract. 2018 May;19(3):349-360. doi: 10.1177/1524839918754868. Epub 2018 Jan 24.
PMID: 29363334
citation: Ingram M, Doubleday K, Bell ML, Lohr A, Murrieta L, Velasco M, Blackburn J, Sabo S, Guernsey de Zapien J, Carvajal SC. Community Health Worker Impact on Chronic Disease Outcomes Within Primary Care Examined Using Electronic Health Records. Am J Public Health. 2017 Oct;107(10):1668-1674. doi: 10.2105/AJPH.2017.303934. Epub 2017 Aug 17.
PMID: 28817321
citation: Reinschmidt KM, Ingram M, Morales S, Sabo SJ, Blackburn J, Murrieta L, David C, Carvajal SC. Documenting Community Health Worker Roles in Primary Care: Contributions to Evidence-Based Integration Into Health Care Teams, 2015. J Ambul Care Manage. 2017 Oct/Dec;40(4):305-315. doi: 10.1097/JAC.0000000000000178.
PMID: 28350634
responsible party type: Sponsor-Investigator
investigator affiliation: University of Arizona
investigator full name: Abby Lohr
investigator title: Senior Research Specialist
mesh term: Chronic Disease
sharing ipd: No