Study to Lower Veterans BP: Patient/Physician Intervention
|First Received Date ICMJE||March 16, 2005|
|Last Updated Date||April 6, 2015|
|Start Date ICMJE||March 2002|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||BP control at primary care visit; Systolic and diastolic BPs as recorded at each primary care provider visit during 24 month enrollment period. [ Designated as safety issue: No ]|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00105716 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Knowledge and perceived risks associated with hypertension and ability to continue hypertension regimen will be assessed at baseline and via telephone 6 and 24 months after baseline; Medication adherence will be assessed from pharmacy records [ Designated as safety issue: No ]|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Study to Lower Veterans BP: Patient/Physician Intervention|
|Official Title ICMJE||Study to Lower Veterans Blood Pressure: Patient/Physician Intervention|
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.
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.
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.
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.
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.
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
|Study Arm (s)||Arm 1
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Enrollment ICMJE||544|
|Completion Date||April 2005|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00105716|
|Other Study ID Numbers ICMJE||IIR 20-034|
|Has Data Monitoring Committee||No|
|Responsible Party||VA Office of Research and Development|
|Study Sponsor ICMJE||VA Office of Research and Development|
|Collaborators ICMJE||Not Provided|
|Information Provided By||VA Office of Research and Development|
|Verification Date||April 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP