Prosperando: Fostering Resilience on Dialysis

  • STATUS
    Recruiting
  • End date
    Dec 5, 2023
  • participants needed
    140
  • sponsor
    University of Colorado, Denver
Updated on 26 May 2022
Accepts healthy volunteers

Summary

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).

Description

The goal of this project is to assess the feasibility and acceptability of a pilot RCT of a culturally tailored peer-navigator (PN) intervention to improve patient-centered and clinical outcomes for Latino patients with end-stage kidney disease (ESKD). We will compare a culturally tailored intervention that includes a PN to control (standard care). In the culturally tailored intervention, the bilingual PN will provide support with social challenges during 5 visits. We will assess the feasibility of (1) referral, (2) recruitment, (3) retention, (4) intervention implementation, and (5) data collection. We will also assess various outcomes including inter-dialytic weight gain and other adherence and patient-centered outcomes.

Specific Aim 1: Conduct a pilot RCT of the peer navigator intervention to assess feasibility, acceptability, as well as outcomes of the proposed peer navigator intervention.

Hypothesis 1: A culturally tailored intervention that consists of a bilingual/culture-concordant peer navigator that provides support with social challenges and support with adherence using motivational interviewing for Latino end-stage kidney disease (ESKD) patients, is feasible and acceptable.

Details
Condition Racial/Ethnic Minorities on Dialysis
Treatment Active Comparator: peer navigator, Placebo Comparator: Control Arm (standard of care)
Clinical Study IdentifierNCT03978806
SponsorUniversity of Colorado, Denver
Last Modified on26 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Self-identify as Latino
Age between 18 and 90 years
Diagnosed with end-stage kidney disease
Received standard (thrice-weekly HD) for at least 3 months
No active substance use (e.g. heavy etoh or opiates)
Speak English or Spanish as a primary language
Participants must be able to provide informed consent

Exclusion Criteria

Active suicidal intent
Present or past psychosis or bipolar disorder
Patient to receive kidney transplantation in the next 3 months
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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