xml: <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/NCT05998850</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00004663</org_study_id>
      <nct_id>NCT05998850</nct_id>
    </id_info>
    <brief_title>Dialysis CHW Pilot</brief_title>
    <official_title>Community Health Worker Navigation of Community Resources for Dialysis Patients: A Pilot Intervention</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Texas at Austin</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Texas at Austin</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        To determine the acceptability and feasibility of a community health worker intervention that&#xD;
        assists dialysis patients with low socioeconomic status navigate community resources to&#xD;
        address health-related social needs. Findings will be used for a future randomized trial that&#xD;
        determines the efficacy of the CHW intervention on mental health, quality of life, addressing&#xD;
        social needs, and clinical outcomes. This study is intended to be generalizable in all&#xD;
        dialysis centers.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The research team will conduct a single-arm 6-month pilot study testing the feasibility of&#xD;
        implementing a tailored, health-related social needs intervention among dialysis patients.&#xD;
        The research teamwill recruit 30 dialysis (all modalities) patients aged≥18 years with low&#xD;
        socioeconomic status to participate in a CHW intervention. The CHW intervention will be&#xD;
        modeled after IMPaCT (Individualized Management for Patient-Centered Targets), a 6-month CHW&#xD;
        intervention that addresses &quot;upstream&quot; socioeconomic and behavioral barriers to treatment for&#xD;
        individuals with chronic diseases, which has been adapted to numerous populations and shown&#xD;
        to improve care and reduce hospitalizations. The CHW will identify health-related social&#xD;
        needs and help participants navigate community resources to meet needs. All participants will&#xD;
        receive the intervention. All participants will also participate in a CHW-led support group,&#xD;
        that will occur monthly. The research team will compare outcomes during the 6-months before&#xD;
        and during the intervention period. This pilot study aims to (1) assess the feasibility of&#xD;
        recruiting dialysis patients experiencing health-related social needs to an intervention&#xD;
        trial, and (2) assess the feasibility of implementing the intervention within this&#xD;
        population, in a fashion deemed acceptable.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>IMPaCT (Individualized Management for Patient-Centered Targets)</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of participant recruited and ended intervention</measure>
      <time_frame>1-year</time_frame>
      <description>To measure Study Feasibility the research team will be assessing the number of participants enrolled and recruitment at the beginning of the intervention and the number of participants that engage by ending the intervention. These measurements will provide information on the feasibility of the intervention among low-income people receiving dialysis treatment.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants accepting the CWH intervention as helpful</measure>
      <time_frame>1-year</time_frame>
      <description>Assess acceptability at follow-up with a focus group. All participants will complete a focus group that discusses: (1) whether the CHW's guidance/assistance was helpful in meeting needs; (2) the utility of having the CHW work with them outside of the dialysis unit; (3) the perceived knowledge of the CHW; (4) the perceived willingness and ability of community partners to participate in the intervention; (5) general satisfaction; and (6) input on the intervention design. This qualitative analysis on the acceptability of the intervention among the participants will provide us with data on which components of the intervention are feasible to improve the quality of life and health in the target population, and what type of components we should improve and/or change to increase the effectiveness of the intervention. acceptability.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of participants changing levels of depression in pre-post test</measure>
      <time_frame>1-Year</time_frame>
      <description>This study will not be powered to detect differences in outcomes. However, in order to estimate the needed sample size for a future trial, the research team will collect information on the following outcomes pre-post changes in symptoms of depression by using the Beck depression inventory. The research team is expecting in the future that the levels of depression will get lower or none after the intervention.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants changing levels of anxiety in pre-post</measure>
      <time_frame>1-Year</time_frame>
      <description>This study will not be powered to detect differences in outcomes. However, in order to estimate the needed sample size for a future trial, the research team will collect information on the following outcomes pre-post changes in symptoms of anxiety by using GAD-7 Anxiety inventory. The research team is expecting in the future that the levels of anxiety will get lower or none after the intervention.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants changing levels of quality of life in pre-post</measure>
      <time_frame>1-Year</time_frame>
      <description>This study will not be powered to detect differences in outcomes. However, in order to estimate the needed sample size for a future trial, the research team will collect information on the following outcomes pre-post changes in the quality of life. The research team is expecting in the future that the levels of better quality of life will get higher after the intervention.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of connection with community resources per participants in pre-post</measure>
      <time_frame>1-Year</time_frame>
      <description>The research team is expecting a greater amount of connection made with a community resource after the intervention.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of dialysis session missed, ended early and amount of participants in transplanting listing.</measure>
      <time_frame>1-Year</time_frame>
      <description>The research team is expecting less number of missed dialysis sessions, an increase in the number of times the participant ended a dialysis session early, and an increase of participants in transplant listing.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Chronic Kidney Diseases</condition>
    <condition>RENAL INSUFFICIENCY, CHRONIC</condition>
    <arm_group>
      <arm_group_label>CHW Dialysis Implementation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A single-arm 6-month pilot study testing the feasibility of tailored implementation, by using IMPaCT model with a Community Health Worker to help low-income dialysis patient to navigate the health system and community resources to eliminate or minimize health-related social needs among dialysis patients so that they adhere to the treatment, improve their health and may be candidates for transplantation.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Community Health Worker Support with Resources</intervention_name>
      <description>6-months of hands-on tailored support spanning the domains of social support, advocacy and navigation to achieve their action plans.</description>
      <arm_group_label>CHW Dialysis Implementation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Have kidney failure and be receiving dialysis&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Live in a nursing facility or institution&#xD;
  &#xD;
            -  Physically or mentally unable or unwilling to participate&#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>Tessa K Novick, MSW, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Texas at Austin</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Michelle M Osuna, PhD</last_name>
      <phone>512-471-0010</phone>
      <email>michelle.osuna@austin.utexas.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Kate Sebastian, RN, MPH</last_name>
      <phone>512-471-0010</phone>
      <email>kate.sebastian@austin.utexas.edu</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Texas at Austin</investigator_affiliation>
      <investigator_full_name>Tessa Novick</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Kidney Diseases</mesh_term>
      <mesh_term>Renal Insufficiency, Chronic</mesh_term>
      <mesh_term>Renal Insufficiency</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05998850
  org study id: STUDY00004663
  nct id: NCT05998850
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  To determine the acceptability and feasibility of a community health worker intervention that
        assists dialysis patients with low socioeconomic status navigate community resources to
        address health-related social needs. Findings will be used for a future randomized trial that
        determines the efficacy of the CHW intervention on mental health, quality of life, addressing
        social needs, and clinical outcomes. This study is intended to be generalizable in all
        dialysis centers.
  The research team will conduct a single-arm 6-month pilot study testing the feasibility of
        implementing a tailored, health-related social needs intervention among dialysis patients.
        The research teamwill recruit 30 dialysis (all modalities) patients aged≥18 years with low
        socioeconomic status to participate in a CHW intervention. The CHW intervention will be
        modeled after IMPaCT (Individualized Management for Patient-Centered Targets), a 6-month CHW
        intervention that addresses "upstream" socioeconomic and behavioral barriers to treatment for
        individuals with chronic diseases, which has been adapted to numerous populations and shown
        to improve care and reduce hospitalizations. The CHW will identify health-related social
        needs and help participants navigate community resources to meet needs. All participants will
        receive the intervention. All participants will also participate in a CHW-led support group,
        that will occur monthly. The research team will compare outcomes during the 6-months before
        and during the intervention period. This pilot study aims to (1) assess the feasibility of
        recruiting dialysis patients experiencing health-related social needs to an intervention
        trial, and (2) assess the feasibility of implementing the intervention within this
        population, in a fashion deemed acceptable.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: IMPaCT (Individualized Management for Patient-Centered Targets)
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Number of participant recruited and ended intervention
  time frame: 1-year
  description: To measure Study Feasibility the research team will be assessing the number of participants enrolled and recruitment at the beginning of the intervention and the number of participants that engage by ending the intervention. These measurements will provide information on the feasibility of the intervention among low-income people receiving dialysis treatment.
  measure: Number of participants accepting the CWH intervention as helpful
  time frame: 1-year
  description: Assess acceptability at follow-up with a focus group. All participants will complete a focus group that discusses: (1) whether the CHW's guidance/assistance was helpful in meeting needs; (2) the utility of having the CHW work with them outside of the dialysis unit; (3) the perceived knowledge of the CHW; (4) the perceived willingness and ability of community partners to participate in the intervention; (5) general satisfaction; and (6) input on the intervention design. This qualitative analysis on the acceptability of the intervention among the participants will provide us with data on which components of the intervention are feasible to improve the quality of life and health in the target population, and what type of components we should improve and/or change to increase the effectiveness of the intervention. acceptability.
  measure: Number of participants changing levels of depression in pre-post test
  time frame: 1-Year
  description: This study will not be powered to detect differences in outcomes. However, in order to estimate the needed sample size for a future trial, the research team will collect information on the following outcomes pre-post changes in symptoms of depression by using the Beck depression inventory. The research team is expecting in the future that the levels of depression will get lower or none after the intervention.
  measure: Number of participants changing levels of anxiety in pre-post
  time frame: 1-Year
  description: This study will not be powered to detect differences in outcomes. However, in order to estimate the needed sample size for a future trial, the research team will collect information on the following outcomes pre-post changes in symptoms of anxiety by using GAD-7 Anxiety inventory. The research team is expecting in the future that the levels of anxiety will get lower or none after the intervention.
  measure: Number of participants changing levels of quality of life in pre-post
  time frame: 1-Year
  description: This study will not be powered to detect differences in outcomes. However, in order to estimate the needed sample size for a future trial, the research team will collect information on the following outcomes pre-post changes in the quality of life. The research team is expecting in the future that the levels of better quality of life will get higher after the intervention.
  measure: Number of connection with community resources per participants in pre-post
  time frame: 1-Year
  description: The research team is expecting a greater amount of connection made with a community resource after the intervention.
  measure: Number of dialysis session missed, ended early and amount of participants in transplanting listing.
  time frame: 1-Year
  description: The research team is expecting less number of missed dialysis sessions, an increase in the number of times the participant ended a dialysis session early, and an increase of participants in transplant listing.
  arm group label: CHW Dialysis Implementation
  arm group type: Experimental
  description: A single-arm 6-month pilot study testing the feasibility of tailored implementation, by using IMPaCT model with a Community Health Worker to help low-income dialysis patient to navigate the health system and community resources to eliminate or minimize health-related social needs among dialysis patients so that they adhere to the treatment, improve their health and may be candidates for transplantation.
  intervention type: Behavioral
  intervention name: Community Health Worker Support with Resources
  description: 6-months of hands-on tailored support spanning the domains of social support, advocacy and navigation to achieve their action plans.
  arm group label: CHW Dialysis Implementation
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Tessa K Novick, MSW, MD
  role: Principal Investigator
  affiliation: University of Texas at Austin
  last name: Michelle M Osuna, PhD
  phone: 512-471-0010
  email: michelle.osuna@austin.utexas.edu
  last name: Kate Sebastian, RN, MPH
  phone: 512-471-0010
  email: kate.sebastian@austin.utexas.edu
  responsible party type: Principal Investigator
  investigator affiliation: University of Texas at Austin
  investigator full name: Tessa Novick
  investigator title: Assistant Professor
  mesh term: Kidney Diseases
  mesh term: Renal Insufficiency, Chronic
  mesh term: Renal Insufficiency
  sharing ipd: Undecided