Prosperando: Fostering Resilience on Dialysis

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Racial/Ethnic Minorities on Dialysis

Treatments: Behavioral: Active Comparator: peer navigator; Other: Placebo Comparator: Control Arm (standard of care)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03978806

20-0419

Details and patient eligibility

About

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).

Full 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.

Enrollment: 139 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Exclusion criteria

1. Active suicidal intent
2. Present or past psychosis or bipolar disorder
3. Patient to receive kidney transplantation in the next 3 months

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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139 participants in 2 patient groups, including a placebo group

peer navigator

Active Comparator group

Description:

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.

Treatment:

Behavioral: Active Comparator: peer navigator

Control Arm (standard of care)

Placebo Comparator group

Description:

Standard of care

Treatment:

Other: Placebo Comparator: Control Arm (standard of care)