Abstract
IMPORTANCE: Hispanic and Latino individuals with hemodialysis-dependent kidney failure experience social barriers that may increase their risk for volume-related complications, including fluid accumulation between dialysis sessions or interdialytic weight gain (IDWG). Higher IDWG contributes to cardiovascular complications, hospitalizations, and poor quality of life. Minimizing IDWG is prioritized by patients, clinicians, and payers; yet, high IDWG remains common despite dietary education. OBJECTIVE: To determine if community health worker (CHW) support reduces IDWG among Hispanic and Latino individuals receiving hemodialysis. DESIGN, SETTING, AND PARTICIPANTS: This parallel group, unblinded, multicenter, community-partnered, randomized clinical trial was conducted at 5 dialysis centers in Denver, Colorado, between November 2020 and August 2022. Self-identified Latino or Hispanic adults receiving in-center hemodialysis were eligible. Data were analyzed from August 2024 to July 2025. INTERVENTION: Participants were randomized 1:1 to the Navigate-Kidney intervention or standard care. In Navigate-Kidney, CHWs followed a framework-driven, patient-centered protocol to support patient social needs and provide health navigation and culturally responsive kidney care education, including dietary modification and fluid restriction education. CHWs met participants biweekly for at least 6 visits. Standard care had no trial-driven culturally responsive components. MAIN OUTCOMES AND MEASURES: The primary outcome was change in IDWG from 90 days prior to intervention to 180 days postintervention, calculated as a percentage of estimated dry weight. Secondary outcomes included missed and shortened dialysis sessions, health care utilization, and patient activation. Between-group IDWG differences were estimated with piecewise linear mixed models. RESULTS: Of 139 participants (mean [SD] age, 56.8 [12.9] years; 68 [49%] female), 68 were randomly assigned to Navigate-Kidney and 71 to standard care. Postintervention trends in percentage of estimated dry weight differed between Navigate-Kidney and standard care, which corresponded to a difference between groups of -0.46 percentage points (95% CI, -0.78 to -0.14 percentage points) in IDWG after 180 days of follow-up (P = .01). Mean IDWG was 3.26% (95% CI, 2.83%-3.68%) and 3.72% (95% CI, 3.30%-4.14%) in Navigate-Kidney and standard care, respectively. There were fewer shortened dialysis sessions with Navigate-Kidney vs SC (median [IQR], 0.1 [-1.2 to 1.1] vs 0.6 [-0.5 to 1.8]; P = .02), as well as greater improvement in the Patient Activation Measure (median [IQR], 1.8 [-2.2 to 5.2] points vs -2.2 [-7.4 to 2.5] points; P = .005). CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, a culturally tailored CHW intervention modestly lowered IDWG and improved dialysis adherence and patient activation among Hispanic and Latino patients with hemodialysis-dependent kidney failure. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03978806.