Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705, United States
NCT Number: NCT00105716
This four and a half year trial is evaluating both a patient and a provider intervention in a primary care setting among diagnosed hypertensive veterans. The two primary hypotheses are: 1) the proportion of veterans with BP control who receive either the provider-directed decision support or the patient health education and behavioral intervention will be increased by 10% as compared to usual care; and 2) the proportion of veterans with BP control who receive both the provider-directed decision support and the patient health education and behavioral intervention will be increased by 25% as compared to usual care.
Looking for future studies?
Notify MeAll sexes
Interventional
Not applicable
Durham, North Carolina, 27705, United States
Background:
There are 65 million Americans and over 8.5 million veterans who have been diagnosed with hypertension, yet only 31% have their blood pressure (BP) under effective control. Uncontrolled hypertension greatly increases the risk of stroke, CAD, renal failure, CHF, and mortality.
Objectives:
This four year study evaluated simultaneously both a patient and a provider intervention in a primary care setting among diagnosed hypertensive veterans. The two primary hypotheses were: 1) the proportion of veterans with BP control who receive either the provider-directed decision support or the patient behavioral/education intervention will be increased by 10% as compared to usual care; and 2) the proportion of veterans with BP control who receive both the provider-directed decision support and the patient health education and behavioral intervention will be increased by 25% as compared to usual care.
Methods:
This was a randomized controlled trial with a split-plot design. Thirty primary care providers in the Durham VAMC Primary Care Clinic were randomly assigned to receive either the provider intervention or basic patient information; 588 of their hypertensive patients were randomized to the patient intervention or usual care. The provider intervention (ATHENA study (IIR 99-275) included an electronically generated hypertension decision support system (DSS) delivered to the provider at each hypertensive patient's visit. The provider intervention was designed to improve guideline concordant therapy. The patient intervention was a tailored behavioral/education intervention administered at periodic telephone contacts. The intervention included support and reminders, information on hypertension and on health behaviors. Patients received feedback about their recent BP values, continuous patient education, and were monitored and supported to enhance adherence. The control group was usual care.
Status:
Complete. Major activities completed in the past 12 months include submission of a manuscript describing the study, the interventions, and baseline and follow-up analyses. Secondary analyses are being completed which will be included in additional manuscripts.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
US Department of Veterans Affairs
Fed
Study to Lower Veterans Blood Pressure: Patient/Physician Intervention
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02439775
Cardiovascular Diseases, Hypertension
Huntsville, Alabama, United States
View Trial DetailsNCT05820295
Arrhythmias, Cardiac, Atrial Fibrillation
New York, United States
View Trial DetailsNCT06380322
Cardiovascular Diseases, Diabetes Mellitus
Fort Carson, Colorado, United States
View Trial DetailsNCT06961981
Cardiovascular Diseases, Hypertension
Morgantown, West Virginia, United States
View Trial Details