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
About this trial
This is an interventional health services research trial for Chronic Kidney Diseases
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
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
NCT ID
NCT05998850
First Posted
July 19, 2023
Last Updated
August 10, 2023
Sponsor
University of Texas at Austin
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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Dialysis CHW Pilot
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