Dialysis CHW Pilot

Community Health Worker Navigation of Community Resources for Dialysis Patients: a Pilot Intervention

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Diseases; RENAL INSUFFICIENCY, CHRONIC
• Intervention / Treatment: Behavioral: Community Health Worker Support with Resources

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78712
      • University of Texas at Austin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: CHW Dialysis Implementation; 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.

Behavioral: Community Health Worker Support with Resources; 6-months of hands-on tailored support spanning the domains of social support, advocacy and navigation to achieve their action plans.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1-year
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.	1-year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1-Year
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.	1-Year
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.	1-Year
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.	1-Year
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.	1-Year

Collaborators and Investigators

• Sponsor: University of Texas at Austin
• Investigators: Principal Investigator: Tessa K Novick, MSW, MD, University of Texas at Austin

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): October 31, 2024
• Study Completion (Actual): October 31, 2024

Study Registration Dates

• First Submitted: July 19, 2023
• First Submitted That Met QC Criteria: August 10, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: STUDY00004663

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will develop manuscripts and do presentations to release information and results.
• IPD Sharing Time Frame: The data will become available in 2025 and will be available for two years.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No