CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 139 enrolled
Drug / intervention
Active Comparator: peer navigator +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03978806
NCT03978806N/ACompleted

Fostering Resilience on Dialysis: A Peer Navigator Study to Improve the Well-being of Latinos on Hemodialysis

University of Colorado, Denver·interventional·Posted Jun 7, 2019·Updated Oct 21, 2024

In Brief

A clinical study evaluating Active Comparator: peer navigator and Placebo Comparator: Control Arm (standard of care) for Racial/Ethnic Minorities on Dialysis. Completed, enrolled 139 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJun 7, 2019
Enrollment StartOct 5, 2020
Primary CompletionJul 7, 2024
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 7.1 years ago

Interventions

Active Comparator: peer navigatorbehavioral

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.

Placebo Comparator: Control Arm (standard of care)other

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