Simultaneous Risk Factor Control Using Telehealth to slOw Progression of Diabetic Kidney Disease (STOP-DKD) study: Protocol and baseline characteristics of a randomized controlled trial.
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2018-06
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Abstract
Diabetic kidney disease (DKD) is the leading cause of end-stage kidney disease (ESKD) in the United States. Multiple risk factors contribute to DKD development, yet few interventions target more than a single DKD risk factor at a time. This manuscript describes the study protocol, recruitment, and baseline participant characteristics for the Simultaneous Risk Factor Control Using Telehealth to slOw Progression of Diabetic Kidney Disease (STOP-DKD) study. The STOP-DKD study is a randomized controlled trial designed to evaluate the effectiveness of a multifactorial behavioral and medication management intervention to mitigate kidney function decline at 3 years compared to usual care. The intervention consists of up to 36 monthly educational modules delivered via telephone by a study pharmacist, home blood pressure monitoring, and medication management recommendations delivered electronically to primary care physicians. Patients seen at seven primary care clinics in North Carolina, with diabetes and [1] uncontrolled hypertension and [2] evidence of kidney dysfunction (albuminuria or reduced estimated glomerular filtration rate [eGFR]) were eligible to participate. Study recruitment completed in December 2014. Of the 281 participants randomized, mean age at baseline was 61.9; 52% were male, 56% were Black, and most were high school graduates (89%). Baseline co-morbidity was high- mean blood pressure was 134/76 mmHg, mean body mass index was 35.7 kg/m2, mean eGFR was 80.7 ml/min/1.73 m2, and mean glycated hemoglobin was 8.0%. Experiences of recruiting and implementing a comprehensive DKD program to individuals at high risk seen in the primary care setting are provided.
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NCT01829256.Type
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Diamantidis, Clarissa J, Hayden B Bosworth, Megan M Oakes, Clemontina A Davenport, Jane F Pendergast, Sejal Patel, Jivan Moaddeb, Huiman X Barnhart, et al. (2018). Simultaneous Risk Factor Control Using Telehealth to slOw Progression of Diabetic Kidney Disease (STOP-DKD) study: Protocol and baseline characteristics of a randomized controlled trial. Contemporary clinical trials, 69. pp. 28–39. 10.1016/j.cct.2018.04.003 Retrieved from https://hdl.handle.net/10161/29883.
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Scholars@Duke
Clarissa Jonas Diamantidis
Hayden Barry Bosworth
Dr. Bosworth is a health services researcher and Deputy Director of the Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT) at the Durham VA Medical Center. He is also Vice Chair of Education and Professor of Population Health Sciences. He is also a Professor of Medicine, Psychiatry, and Nursing at Duke University Medical Center and Adjunct Professor in Health Policy and Administration at the School of Public Health at the University of North Carolina at Chapel Hill. His research interests comprise three overarching areas of research: 1) clinical research that provides knowledge for improving patients’ treatment adherence and self-management in chronic care; 2) translation research to improve access to quality of care; and 3) eliminate health care disparities.
Dr. Bosworth is the recipient of an American Heart Association established investigator award, the 2013 VA Undersecretary Award for Outstanding Achievement in Health Services Research (The annual award is the highest honor for VA health services researchers), and a VA Senior Career Scientist Award. In terms of self-management, Dr. Bosworth has expertise developing interventions to improve health behaviors related to hypertension, coronary artery disease, and depression, and has been developing and implementing tailored patient interventions to reduce the burden of other chronic diseases. These trials focus on motivating individuals to initiate health behaviors and sustaining them long term and use members of the healthcare team, particularly pharmacists and nurses. He has been the Principal Investigator of over 30 trials resulting in over 400 peer reviewed publications and four books. This work has been or is being implemented in multiple arenas including Medicaid of North Carolina, private payers, The United Kingdom National Health System Direct, Kaiser Health care system, and the Veterans Affairs.
Areas of Expertise: Health Behavior, Health Services Research, Implementation Science, Health Measurement, and Health Policy
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.
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.
Prior efforts focused on four inter-related areas that are essential to improving kidney health: i) reducing the progression of chronic kidney disease by improving its detection and management, particularly by leveraging technology to facilitate engagement and self-management; ii) elucidating the inter-relationships between kidney disease and cardiovascular disease, which together amplify the risk of death; iii) improving the evidence in nephrology through comparative effectiveness research, including clinical trials, observational studies, and meta-analyses; and iv) promoting more optimal clinical health policy for all patients with kidney disease. These inter-disciplinary projects have been funded by a variety of public and private sources including the Robert Wood Johnson Foundation, Veterans Affairs, National Institutes of Health, Agency for Healthcare Research & Quality, Food and Drug Administration, Centers for Medicare & Medicaid Services, Renal Physicians Association, and the American Society of Nephrology.
Current efforts seek to advance novel therapies for kidney diseases through early clinical development that he leads at AstraZeneca.
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