Prosperando: Fostering Resilience on Dialysis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-05

Study Completion Date

2024-07-07

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Racial/Ethnic Minorities on Dialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This will be a pilot RCT (randomized controlled trial) of a 3 month intervention of Latino ESRD patients that will be randomized to one of two arms: 1) PN Arm, in which a bilingual PN provides support with social factors and support with adherence using motivational interviewing during 5 visits or 2) Control (standard care) Arm.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators

The PI will not know arm assignment.

Study Groups

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peer navigator

The first PN visit will take place within 1-2 weeks of consent. Each of the 5 subsequent PN visits will take place every 1-2 weeks. We expect patients to complete the intervention within 2-3 months of consent. The function of the initial visit is to establish trust and ensure a more personal approach with participants. The community-based PN intervention is grounded in core Latino values (e.g. trust, personalized relationships). The core elements of the PN intervention include patient motivational interviewing as well as patient activation, empowerment (e.g. help with scheduling of healthcare appointments and re-scheduling of missed HD sessions), education (e.g. education of ESKD and need for renal replacement therapy), and social challenges (e.g. access to resources for transportation, benefits, immigration issues). The duration, individuals present during the visit, and content discussed will be documented in the visit form.

Group Type ACTIVE_COMPARATOR

Active Comparator: peer navigator

Intervention Type BEHAVIORAL

The intervention is aimed to provide support with social challenges and adherence. The peer navigator will meet with patients to provide support with social challenges and use motivational interviewing to provide support with adherence.

Control Arm (standard of care)

Standard of care

Group Type PLACEBO_COMPARATOR

Placebo Comparator: Control Arm (standard of care)

Intervention Type OTHER

Control patients will have met the same inclusion and exclusion criteria as intervention patients.

Interventions

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Active Comparator: peer navigator

The intervention is aimed to provide support with social challenges and adherence. The peer navigator will meet with patients to provide support with social challenges and use motivational interviewing to provide support with adherence.

Intervention Type BEHAVIORAL

Placebo Comparator: Control Arm (standard of care)

Control patients will have met the same inclusion and exclusion criteria as intervention patients.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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