Clinical trial NCT05998850: Dialysis CHW Pilot
Official title: Community Health Worker Navigation of Community Resources for Dialysis Patients: A Pilot Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Diseases
RENAL INSUFFICIENCY, CHRONIC
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: IMPaCT (Individualized Management for Patient-Centered Targets)
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Number of participant recruited and ended intervention
timeFrame: 1-year
measure: Number of participants accepting the CWH intervention as helpful
timeFrame: 1-year
Secondary outcomes:
measure: Number of participants changing levels of depression in pre-post test
timeFrame: 1-Year
measure: Number of participants changing levels of anxiety in pre-post
timeFrame: 1-Year
measure: Number of participants changing levels of quality of life in pre-post
timeFrame: 1-Year
measure: Number of connection with community resources per participants in pre-post
timeFrame: 1-Year
measure: Number of dialysis session missed, ended early and amount of participants in transplanting listing.
timeFrame: 1-Year
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Tessa K Novick, MSW, MD
role: PRINCIPAL_INVESTIGATOR
References: