- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07819487
A Community Health Worker Service to Address Acute Care Utilization Among Young and Middle-Aged Men and Women Receiving Dialysis in High-Poverty Communities
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.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Kathryn Taylor, MD
- Telefonnummer: 410-955-5000
- E-post: ktaylo45@jhmi.edu
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
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%
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: OTHER
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of scheduled dialysis sessions attended
Tidsram: Baseline to end of study, approximately 9 months
|
Adherence to Dialysis Treatment |
Baseline to end of study, approximately 9 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Kathryn Taylor, MD, Johns Hopkins University
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- IRB00518107
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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