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Dialysis CHW Pilot

Primary Purpose

Chronic Kidney Diseases, RENAL INSUFFICIENCY, CHRONIC

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Community Health Worker Support with Resources
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Kidney Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Have kidney failure and be receiving dialysis Exclusion Criteria: Live in a nursing facility or institution Physically or mentally unable or unwilling to participate

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    CHW Dialysis Implementation

    Arm 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.

    Outcomes

    Primary Outcome Measures

    Number of participant recruited and ended intervention
    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.
    Number of participants accepting the CWH intervention as helpful
    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.

    Secondary Outcome Measures

    Number of participants changing levels of depression in pre-post test
    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.
    Number of participants changing levels of anxiety in pre-post
    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.
    Number of participants changing levels of quality of life in pre-post
    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.
    Number of connection with community resources per participants in pre-post
    The research team is expecting a greater amount of connection made with a community resource after the intervention.
    Number of dialysis session missed, ended early and amount of participants in transplanting listing.
    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.

    Full Information

    First Posted
    July 19, 2023
    Last Updated
    August 10, 2023
    Sponsor
    University of Texas at Austin
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05998850
    Brief Title
    Dialysis CHW Pilot
    Official Title
    Community Health Worker Navigation of Community Resources for Dialysis Patients: A Pilot Intervention
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    August 31, 2025 (Anticipated)
    Study Completion Date
    August 31, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Texas at Austin

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Kidney Diseases, RENAL INSUFFICIENCY, CHRONIC

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    IMPaCT (Individualized Management for Patient-Centered Targets)
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    CHW Dialysis Implementation
    Arm Type
    Experimental
    Arm 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(s)
    Community Health Worker Support with Resources
    Intervention Description
    6-months of hands-on tailored support spanning the domains of social support, advocacy and navigation to achieve their action plans.
    Primary Outcome Measure Information:
    Title
    Number of participant recruited and ended intervention
    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.
    Time Frame
    1-year
    Title
    Number of participants accepting the CWH intervention as helpful
    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.
    Time Frame
    1-year
    Secondary Outcome Measure Information:
    Title
    Number of participants changing levels of depression in pre-post test
    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.
    Time Frame
    1-Year
    Title
    Number of participants changing levels of anxiety in pre-post
    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.
    Time Frame
    1-Year
    Title
    Number of participants changing levels of quality of life in pre-post
    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.
    Time Frame
    1-Year
    Title
    Number of connection with community resources per participants in pre-post
    Description
    The research team is expecting a greater amount of connection made with a community resource after the intervention.
    Time Frame
    1-Year
    Title
    Number of dialysis session missed, ended early and amount of participants in transplanting listing.
    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.
    Time Frame
    1-Year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Have kidney failure and be receiving dialysis Exclusion Criteria: Live in a nursing facility or institution Physically or mentally unable or unwilling to participate
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Michelle M Osuna, PhD
    Phone
    512-471-0010
    Email
    michelle.osuna@austin.utexas.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kate Sebastian, RN, MPH
    Phone
    512-471-0010
    Email
    kate.sebastian@austin.utexas.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tessa K Novick, MSW, MD
    Organizational Affiliation
    University of Texas at Austin
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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