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

30. september 2026 oppdatert av: Johns Hopkins University

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Hemodialyse

Studietype

Observasjonsmessig

Registrering (Antatt)

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Navn: Kathryn Taylor, MD
Telefonnummer: 410-955-5000
E-post: ktaylo45@jhmi.edu

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 49 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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%

Beskrivelse

Inclusion Criteria:

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.

Exclusion Criteria:

Residence in a long-term care facility

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Observasjonsmodeller: OTHER
Tidsperspektiver: PROSPECTIVE

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
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.

Gruppe / Kohort

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.

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Percentage of scheduled dialysis sessions attended Tidsramme: Baseline to end of study, approximately 9 months	Adherence to Dialysis Treatment	Baseline to end of study, approximately 9 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Johns Hopkins University

Etterforskere

Hovedetterforsker: Kathryn Taylor, MD, Johns Hopkins University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. desember 2026

Primær fullføring (Antatt)

30. september 2028

Studiet fullført (Antatt)

30. september 2028

Datoer for studieregistrering

Først innsendt

9. september 2026

Først innsendt som oppfylte QC-kriteriene

9. september 2026

Først lagt ut (Faktiske)

15. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

IRB00518107

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .