HemodialysisNCT07819487
A Community Health Worker Service to Address Acute Care Utilization Among Young and Middle-Aged Men and Women Receiving Dialysis in High-Poverty Communities
An observational study of Hemodialysis, run by Johns Hopkins University.
Trial summary
Among adults receiving in-center hemodialysis, young and middle-aged women (aged 18 to 49) have the highest hospitalization rates at 1.8 per person-year. Sex differences are most pronounced in this age group, even after accounting for multiple confounding factors, including comorbidities, primary insurance type, and… Read more about this study
- Who is it for?
- Ages 18 to 49 years
- Conditions the study is for
- Hemodialysis
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 30 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 49 years
- All sexes
- No healthy volunteers
- Adult
Study population: Participants receiving in-center or home dialysis from facilities in Baltimore City or from facilities in Baltimore County if poverty rates in the surrounding community are ≥20%
Who may be able to join
- Age 18 - 49 years
- Receiving in-center or home dialysis from facilities in Baltimore City or from facilities in Baltimore County if poverty rates in the surrounding community are ≥20%
- Initiated dialysis after age 18; able to provide informed consent.
Who cannot join
- Residence in a long-term care facility
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Pilot Testing a Community Health Worker Service to Address Acute Care Utilization Among Young and Middle-Aged Men and Women Receiving Dialysis in High-Poverty Communities
Among adults receiving in-center hemodialysis, young and middle-aged women (aged 18 to 49) have the highest hospitalization rates at 1.8 per person-year. Sex differences are most pronounced in this age group, even after accounting for multiple confounding factors, including comorbidities, primary insurance type, and length of time on dialysis. Sex differences exist across racial groups and within high-poverty communities. For example, women aged 18 to 49 who receive in-center hemodialysis and live in Baltimore City experience 2.9 hospital admissions per year compared to 1.2 admissions per year in men. Moreover, sex differences reflect underlying health - sex differences are markedly attenuated when comparing women and men with similar levels of systemic inflammation. Community health worker (CHW) models are an evidence-based approach to reduce acute care utilization, but have not been widely implemented in dialysis or targeted risk factors unique to young and middle-aged women receiving dialysis in high-poverty communities. The proposed study will address this gap by pilot testing a CHW service adapted for this population.
- Conditions
- Hemodialysis
- Keywords
- hemodialysis, Community health worker, Sex differences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dialysis Facility Staff Focus Group | After obtaining Institutional Review Board (IRB) approval, the PI will contact dialysis facility staff to determine interest in participating in focus groups. The PI will attempt to contact staff members no more than 2 times. * For dialysis facility staff members, the investigators will initially invite staff within the study team's existing professional networks (e.g., the nephrologist and clinic manager at dialysis facilities where study team members see patients). * If those staff members are not available, the investigators will work with dialysis facility leadership to identify available and interested dieticians and social workers in the Baltimore area via passive recruitment methods, such as a post via the organization's internal messaging software. The investigators will submit a change in research to enable IRB review of the recruitment post if the investigators need to recruit dialysis facility staff via internal messaging. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of scheduled dialysis sessions attended
Adherence to Dialysis Treatment
Measured: Baseline to end of study, approximately 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start1 Dec 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathryn Taylor, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07819487
- Sponsor's protocol ID
- IRB00518107
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Testing a Community Health Worker Service to Address Acute Care Utilization Among Young and Middle-Aged Men and Women Receiving Dialysis in High-Poverty Communities
- ClinicalTrials.gov ID
- NCT07819487
- Acronym / sponsor ID
- IRB00518107
- Conditions
- Hemodialysis
- Keywords
- hemodialysis, Community health worker, Sex differences
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 15 Sep 2026 (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.
Among adults receiving in-center hemodialysis, young and middle-aged women (aged 18 to 49) have the highest hospitalization rates at 1.8 per person-year. Sex differences are most pronounced in this age group, even after accounting for multiple confounding factors, including comorbidities, primary insurance type, and length of time on dialysis. Sex differences exist across racial groups and within high-poverty communities. For example, women aged 18 to 49 who receive in-center hemodialysis and live in Baltimore City experience 2.9 hospital admissions per year compared to 1.2 admissions per year in men. Moreover, sex differences reflect underlying health - sex differences are markedly attenuated when comparing women and men with similar levels of systemic inflammation. Community health worker (CHW) models are an evidence-based approach to reduce acute care utilization, but have not been widely implemented in dialysis or targeted risk factors unique to young and middle-aged women receiving dialysis in high-poverty communities. The proposed study will address this gap by pilot testing a CHW service adapted for this population.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dialysis Facility Staff Focus Group | – | –After obtaining Institutional Review Board (IRB) approval, the PI will contact dialysis facility staff to determine interest in participating in focus groups. The PI will attempt to contact staff members no more than 2 times. * For dialysis facility staff members, the investigators will initially invite staff within the study team's existing professional networks (e.g., the nephrologist and clinic manager at dialysis facilities where study team members see patients). * If those staff members are not available, the investigators will work with dialysis facility leadership to identify available and interested dieticians and social workers in the Baltimore area via passive recruitment methods, such as a post via the organization's internal messaging software. The investigators will submit a change in research to enable IRB review of the recruitment post if the investigators need to recruit dialysis facility staff via internal messaging. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Participants receiving in-center or home dialysis from facilities in Baltimore City or from facilities in Baltimore County if poverty rates in the surrounding community are ≥20%
Key inclusion criteria (3 listed)
- Age 18 - 49 years
- Receiving in-center or home dialysis from facilities in Baltimore City or from facilities in Baltimore County if poverty rates in the surrounding community are ≥20%
- Initiated dialysis after age 18; able to provide informed consent.
Key exclusion criteria (1 listed)
- Residence in a long-term care facility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of scheduled dialysis sessions attended
Time frame: Baseline to end of study, approximately 9 months
Adherence to Dialysis Treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Kathryn Taylor, MD principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodialysis, run by Johns Hopkins University.
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 3 inclusion and 1 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: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kathryn Taylor, MD (410-955-5000, ktaylo45@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of scheduled dialysis sessions attended (time frame: Baseline to end of study, approximately 9 months). 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 1 Oct 2026.