Chronic Kidney DiseasesNCT05998850
Dialysis CHW Pilot
A study testing Community Health Worker Support with Resources in people with Chronic Kidney Diseases and RENAL INSUFFICIENCY, CHRONIC, run by University of Texas at Austin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases, RENAL INSUFFICIENCY, CHRONIC
- What is being tested?
- Community Health Worker Support with Resources
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2023to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have kidney failure and be receiving dialysis
Who cannot join
- Live in a nursing facility or institution
- Physically or mentally unable or unwilling to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Community Health Worker Support with Resources
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Health Worker Support with ResourcesBehavioural
6-months of hands-on tailored support spanning the domains of social support, advocacy and navigation to achieve their action plans.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Community Health Worker Support with Resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1-year
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1-Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Oct 2023
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- IMPaCT (Individualized Management for Patient-Centered Targets)
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tessa Novick, University of Texas at Austin
- Investigators
- Tessa K Novick, MSW, MD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05998850
- Sponsor's protocol ID
- STUDY00004663
- Status last verified
- Mar 2025
- First submitted
- 19 Jul 2023
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will develop manuscripts and do presentations to release information and results.
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Health Worker Navigation of Community Resources for Dialysis Patients: A Pilot Intervention
- ClinicalTrials.gov ID
- NCT05998850
- Acronym / sponsor ID
- STUDY00004663
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- IMPaCT (Individualized Management for Patient-Centered Targets)
| Arm | Type | Receives |
|---|---|---|
| CHW Dialysis Implementation | Experimental | Behavioral: Community Health Worker Support with ResourcesA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Have kidney failure and be receiving dialysis
Key exclusion criteria (2 listed)
- Live in a nursing facility or institution
- Physically or mentally unable or unwilling to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community Health Worker Support with Resources6-months of hands-on tailored support spanning the domains of social support, advocacy and navigation to achieve their action plans. | Behavioural | CHW Dialysis Implementation |
Primary outcome
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.
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.
5 secondary outcomes
Number of participants changing levels of depression in pre-post test
Time frame: 1-Year
Number of participants changing levels of anxiety in pre-post
Time frame: 1-Year
Number of participants changing levels of quality of life in pre-post
Time frame: 1-Year
Number of connection with community resources per participants in pre-post
Time frame: 1-Year
Number of dialysis session missed, ended early and amount of participants in transplanting listing.
Time frame: 1-Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: Yes. We will develop manuscripts and do presentations to release information and results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tessa K Novick, MSW, MD principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Health Worker Support with Resources in people with Chronic Kidney Diseases and RENAL INSUFFICIENCY, CHRONIC, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participant recruited and ended intervention (time frame: 1-year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.