Two recent small clinical trials reported that hypertensive patients with chronic kidney disease or diabetes who were assigned to take at least one antihypertensive at bedtime had a dramatically lower risk of cardiovascular events. The simplicity of the intervention (changing the timing of medication administration), the prevalence of the underlying condition, and the large potential impact of the intervention on improving health make this area an ideal topic for a pragmatic clinical trial. Thus, the proposed trial will determine the effectiveness of nighttime dosing of antihypertensive medications in patients at risk of adverse cardiovascular events. The study will be conducted at two integrated health systems and will build on the innovative work of the investigative team in: 1) developing electronic medical record (EMR) based patient recruitment strategies;2) building interactive web-based platforms for obtaining informed consent;3) extracting research data from EMRs;4) collecting patient-reported outcomes web-based personal health records;and 5) conducting NIH and VA funded multi-site trials in routine primary care settings to improve management of hypertension. During the UH2 component, the investigators will refine and then implement a number of innovative and highly efficient strategies for patient recruitment, data collection, and obtaining informed consent at the two participating sites. During the UH3 component, the team will conduct randomized pragmatic trial to examine the impact of nighttime antihypertensive dosing. The study will enroll an estimated 1100 patients from the two sites during a seven-month period. Patients will be followed for the subsequent 36-42 months to determine the occurrence of major cardiovascular events. Other study endpoints include clinic and sleep time blood pressure, medication adherence, health related quality of life, symptoms, and healthcare utilization. Eligible patients will be identified using EMR-based algorithms. Informed consent will be obtained using an interactive web-based platform or a 1-800 telephone contact with a study coordinator. Study data will be extracted from EMRs at the two participating sites and from web-based personal health records.

Public Health Relevance

This study will involve conducting a simple and practical clinical trial to determine if taking medication for high blood pressure at night, as opposed to in the morning, lead to a lower risk of cardiovascular disease in patients with hypertension. The study will collect data from electronic medical records and from personal health records and will use an innovative website to collect informed consent from patients.

Agency
National Institute of Health (NIH)
Institute
National Center for Complementary & Alternative Medicine (NCCAM)
Type
Exploratory/Developmental Cooperative Agreement Phase I (UH2)
Project #
1UH2AT007784-01
Application #
8465693
Study Section
Special Emphasis Panel (ZAT1-DB (33))
Program Officer
Alekel, D Lee
Project Start
2012-09-30
Project End
2013-12-31
Budget Start
2012-09-30
Budget End
2013-12-31
Support Year
1
Fiscal Year
2012
Total Cost
$770,129
Indirect Cost
$226,132
Name
University of Iowa
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
062761671
City
Iowa City
State
IA
Country
United States
Zip Code
52242
Cook, Andrea J; Delong, Elizabeth; Murray, David M et al. (2016) Statistical lessons learned for designing cluster randomized pragmatic clinical trials from the NIH Health Care Systems Collaboratory Biostatistics and Design Core. Clin Trials 13:504-12
Crockett, Cameron D; Bertrand, Laura A; Cooper, Christopher S et al. (2015) Urologic and gastrointestinal symptoms in the dystroglycanopathies. Neurology 84:532-9
Carter, Barry L; Chrischilles, Elizabeth A; Rosenthal, Gary et al. (2014) Efficacy and safety of nighttime dosing of antihypertensives: review of the literature and design of a pragmatic clinical trial. J Clin Hypertens (Greenwich) 16:115-21
Richesson, Rachel L; Hammond, W Ed; Nahm, Meredith et al. (2013) Electronic health records based phenotyping in next-generation clinical trials: a perspective from the NIH Health Care Systems Collaboratory. J Am Med Inform Assoc 20:e226-31