A Community Health Worker Service to Address Acute Care Utilization Among Young and Middle-Aged Men and Women Receiving Dialysis in High-Poverty Communities

NCT07819487 | Not Yet Recruiting

• 1 other identifier: IRB00518107
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• Percentage of scheduled dialysis sessions attended

  Adherence to Dialysis Treatment

  Baseline to end of study, approximately 9 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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%

You may qualify if:

• 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.

You may not qualify if:

• Residence in a long-term care facility

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Officials

• Kathryn Taylor, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathryn Taylor, MD

CONTACT

410-955-5000; ktaylo45@jhmi.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 15, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share