Dialysis CHW Pilot

NCT05998850 | Completed

• 1 other identifier: STUDY00004663
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases; RENAL INSUFFICIENCY, CHRONIC

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Number of participants changing levels of depression in pre-post test

  1-Year

• Number of participants changing levels of anxiety in pre-post

  1-Year

• Number of participants changing levels of quality of life in pre-post

  1-Year

• Number of connection with community resources per participants in pre-post

  1-Year

• Number of dialysis session missed, ended early and amount of participants in transplanting listing.

  1-Year

Study Arms (1)

CHW Dialysis Implementation

EXPERIMENTAL

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

Interventions

Community Health Worker Support with Resources BEHAVIORAL

6-months of hands-on tailored support spanning the domains of social support, advocacy and navigation to achieve their action plans.

CHW Dialysis Implementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have kidney failure and be receiving dialysis

You may not qualify if:

• Live in a nursing facility or institution
• Physically or mentally unable or unwilling to participate

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Health Resources

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Planning; Health Care Economics and Organizations; Delivery of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Tessa K Novick, MSW, MD

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: IMPaCT (Individualized Management for Patient-Centered Targets)

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: August 21, 2023
• Study Start: October 1, 2023
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will become available in 2025 and will be available for two years.

Locations

US (1)