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Clinical Trials/NCT05998850
NCT05998850
Completed
Not Applicable

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

University of Texas at Austin1 site in 1 country30 target enrollmentOctober 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Kidney Diseases
Sponsor
University of Texas at Austin
Enrollment
30
Locations
1
Primary Endpoint
Number of participants accepting the CWH intervention as helpful
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2023
End Date
October 31, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tessa Novick

Assistant Professor

University of Texas at Austin

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

Outcomes

Primary Outcomes

Number of participants accepting the CWH intervention as helpful

Time Frame: 1-year

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.

Number of participant recruited and ended intervention

Time Frame: 1-year

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.

Secondary Outcomes

  • Number of participants changing levels of depression in pre-post test(1-Year)
  • Number of connection with community resources per participants in pre-post(1-Year)
  • Number of participants changing levels of quality of life in pre-post(1-Year)
  • Number of participants changing levels of anxiety in pre-post(1-Year)
  • Number of dialysis session missed, ended early and amount of participants in transplanting listing.(1-Year)

Study Sites (1)

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