Clinical Outcomes Among High-Risk Primary Care Patients With Diabetic Kidney Disease: Methodological Challenges and Results From the STOP-DKD Study.
Date
2024-07
Journal Title
Journal ISSN
Volume Title
Repository Usage Stats
views
downloads
Citation Stats
Attention Stats
Abstract
Background/objective
Slowing the progression of diabetic kidney disease (DKD) is critical. We conducted a randomized controlled trial to target risk factors for DKD progression.Methods
We evaluated the effect of a pharmacist-led intervention focused on supporting healthy behaviors, medication management, and self-monitoring on decline in estimated glomerular filtration rate (eGFR) for 36 months compared with an educational control.Results
We randomized 138 individuals to the intervention group and 143 to control. At baseline, mean (SD) eGFR was 80.7 (21.7) mL/min/1.73m2, 56% of participants had chronic kidney disease and a history of uncontrolled hypertension with a baseline SBP of 134.3 mm Hg. The mean (SD) decline in eGFR by cystatin C from baseline to 36 months was 5.0 (19.6) and 5.9 (18.6) mL/min/1.73m2 for the control and intervention groups, respectively, with no significant between-group difference (P=0.75).Conclusions
We did not observe a significant difference in clinical outcomes by study arm. However, we showed that individuals with DKD will engage in a pharmacist-led intervention. The potential explanations for a lack of change in DKD risk factors can be attributed to 5 broad issues, challenges: (1) associated with enrolling patients with low eGFR and poor BP control; (2) implementing the intervention; (3) limited duration during which to observe any clinical benefit from the intervention; (4) potential co-intervention or contamination; and (5) low statistical power.Type
Department
Description
Provenance
Subjects
Citation
Permalink
Published Version (Please cite this version)
Publication Info
Bosworth, Hayden B, Uptal D Patel, Allison A Lewinski, Clemontina A Davenport, Jane Pendergast, Megan Oakes, Matthew J Crowley, Leah L Zullig, et al. (2024). Clinical Outcomes Among High-Risk Primary Care Patients With Diabetic Kidney Disease: Methodological Challenges and Results From the STOP-DKD Study. Medical care. 10.1097/mlr.0000000000002043 Retrieved from https://hdl.handle.net/10161/31466.
This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.
Collections
Scholars@Duke
Uptal Dinesh Patel
Uptal Patel, MD is an Adjunct Professor interested in population health with a broad range of clinical and research experience. As an adult and pediatric nephrologist with training in health services and epidemiology, his work seeks to improve population health for patients with kidney diseases through improvements in prevention, diagnosis and treatment. He has led clinical and translational research programs to improve detection and management of kidney disease in a variety of populations.
His current efforts seek to advance targeted therapies for immune-mediated diseases as the Senior Vice President and Head of Development at HI-Bio, at Biogen. Prior to being CMO at HI-Bio, he led clinical strategy, translation, and development of the kidney portfolios at AstraZeneca (within the early cardiovascular, renal, and metabolism therapeutic area) and Gilead Sciences (within the inflammation therapeutic area).
He currently also serves as Chair of the Board of Directors for the Kidney Health Initiative, a public-private partnership between the American Society of Nephrology and the FDA to catalyze innovation and the development of safe and effective patient-centered therapies for people with kidney diseases. He completed training at the University of Michigan in internal medicine, pediatrics, adult nephrology, pediatric nephrology, and health services research after attending medical school at UCSF.
Allison A. Lewinski
I am a health services researcher and implementation scientist with a joint appointment at the Duke University School of Nursing (DUSON) and the Durham Veterans Affairs Health Care System (VHA). My expertise spans diabetes distress, qualitative research methods, and virtual care delivery (including telehealth and digital health).
My research examines how virtual care interventions can reduce distress, improve self-management, expand access to evidence-based care, and enhance patient and population health outcomes. I focus on patient-, provider-, and system-level factors that influence the use and effectiveness of virtual care. This work has been funded by competitive grants, published in high-impact journals, presented at national conferences, and used to inform health system decision-making. I am frequently sought by colleagues locally and nationally for expertise in diabetes distress, qualitative methods, and virtual care strategies for grants, projects, and manuscripts.
I strive to improve outcomes for individuals with chronic illness by developing equitable, sustainable virtual care solutions and evaluating their implementation. To optimize these interventions, I apply qualitative and implementation science approaches to ensure alignment among patient needs, care modalities, disease states, and social contexts. My work addresses critical questions: for whom and for what purposes are these interventions effective, in which contexts, and at what points in the care continuum. Ultimately, my research advances the implementation and adoption of virtual care to reduce psychosocial distress and improve health outcomes through patient-clinician interactions and system-level innovations.
Jane Frances Pendergast
Dr. Pendergast is a senior faculty member in the Department of Biostatistics & Bioinformatics, with specialized expertise in multivariate and longitudinal data. Before coming to Duke, she was a Statistics/Biostatistics faculty member at the Universities of Florida and Iowa. Her primary collaborations at Duke are with members of the Division of General Internal Medicine and the Aging Center.
Huiman Xie Barnhart
My research interests include both statistical methodology and disease-specific clinical research biostatistics. My statistical research areas include methods for outcomes, endpoints, estimands, assessing reliability/agreement between methods or raters, evaluating performance of new medical diagnostic tests, and methods for design of clinical trials. My collaborative research include the following clinical areas: liver injury, cardiovascular imaging, radiology imaging, cardiovascular disease, renal disease, reproductive medicine, Parkinson disease, and aging.
Clarissa Jonas Diamantidis
Unless otherwise indicated, scholarly articles published by Duke faculty members are made available here with a CC-BY-NC (Creative Commons Attribution Non-Commercial) license, as enabled by the Duke Open Access Policy. If you wish to use the materials in ways not already permitted under CC-BY-NC, please consult the copyright owner. Other materials are made available here through the author’s grant of a non-exclusive license to make their work openly accessible.