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NCT03978806

Prosperando: Fostering Resilience on Dialysis

Completed NA Last updated 21 October 2024
What this trial tests

NA trial testing Active Comparator: peer navigator in Racial/Ethnic Minorities on Dialysis in 139 participants. Completed in 7 July 2024.

Timeline
5 October 2020
Primary endpoint
7 July 2024
7 July 2024

Quick facts

Lead sponsorUniversity of Colorado, Denver
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposehealth services research
Enrollment139
Start date5 October 2020
Primary completion7 July 2024
Estimated completion7 July 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Colorado, Denver

Who can join

Adults 18 to 90, any sex, with Racial/Ethnic Minorities on Dialysis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Latinos with End-Stage Renal Disease (ESRD) represent 17% of the US adult ESRD community and suffer a disproportionate burden of social challenges that impacts their well-being. With support from the Amos award from the Robert Wood Johnson Foundation (RWJF), the investigators assessed the feasibility of a 1-arm intervention of a 5-visit lay Peer Navigator intervention to support Latino ESRD patients with social challenges and adherence (using motivational interviewing \& patient activation). This trial will build on the Amos work as a small Randomized Controlled Trial (RCT). The overall aims of this proposal are to: 1) engage key operational and clinical stakeholders early-on to develop a Peer Navigator-intervention; 2) conduct a pilot RCT of the peer navigator intervention versus standard care to test feasibility and acceptability; and 3) assess the efficacy of the intervention on interdialytic weight gain (primary outcome) as well as health-related quality of life, patient activation, and hemodialysis adherence (secondary outcomes).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Community Health Worker Support for Hispanic and Latino Individuals Receiving Hemodialysis: The Navigate-Kidney Randomized Clinical Trial.
    Cervantes L, Juarez-Colunga E, Powe NR, Flythe JE, et al · · 2026 · cited 3× · PMID 41203234 · DOI 10.1001/jamainternmed.2025.5305

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