Year: 2025
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
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.
Source: JAMA Internal Medicine
Language: English
Subfield: Nephrology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Funders: Foundation for the National Institutes of Health, Eli Lilly and Company, Biogen, Fondazione Cassa di Risparmio di Padova e Rovigo, University Research Council, Aga Khan University, Novartis Pharmaceuticals Corporation, Northern California Institute for Research and Education, Blavatnik Family Foundation, National Institute for Health and Care Research, Royal Society, National Research Foundation, University of Capetown, Deutsche Forschungsgemeinschaft, Agence Nationale de la Recherche, International Brain Research Organization, National Natural Science Foundation of China, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior, Ministry of Higher Education, Malaysia, Ministero della Salute, National Research Foundation of Korea, Magyar Tudományos Akadémia, Ligue Contre le Cancer, Lietuvos Mokslo Taryba, Fundação Carlos Chagas Filho de Amparo à Pesquisa do Estado do Rio de Janeiro, Chang Gung Medical Foundation, Universidad de Buenos Aires, Natural Science Foundation of Shandong Province, Yen Tjing Ling Medical Foundation, TrygFonden, Universite Angers, Nemzeti Kutatási Fejlesztési és Innovációs Hivatal, Servier, Taipei Veterans General Hospital, Foundation for Innovative Research Groups of the National Natural Science Foundation of China, Vice-Chancellor for Research, Shiraz University of Medical Sciences, European Society for Clinical Investigation, Ministry of Science and ICT, South Korea, National Science and Technology Major Project, Natural Science Foundation of Sichuan Province, Agencia Nacional de Investigación y Desarrollo, Agencia Nacional de Promoción de la Investigación, el Desarrollo Tecnológico y la Innovación, National Institutes of Health, Genentech, National Institute of Food and Agriculture, GE Healthcare, Novartis Pharmaceuticals UK Limited, HORIZON EUROPE Framework Programme, Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Japan Society for the Promotion of Science, Erasmus+, Agencia Estatal de Investigación, Fujian Provincial Health Technology Project, National Institute on Aging, National Institute of Diabetes and Digestive and Kidney Diseases, National Institute of Biomedical Imaging and Bioengineering, Fondo Nacional de Desarrollo Científico y Tecnológico, HORIZON EUROPE European Research Council, DoD Alzheimer's Disease Neuroimaging Initiative, Margaret McNamara Education Grants, Allergy Society of South Africa
OpenAlex ID: W4416017613