Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00105716
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2005-03-16
Brief Title:
Study to Lower Veterans BP PatientPhysician Intervention
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Study to Lower Veterans Blood Pressure PatientPhysician Intervention
Status:
COMPLETED
Status Verified Date:
2006-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
Background
There are 65 million Americans and over 85 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 behavioraleducation 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 patients visit The provider intervention was designed to improve guideline concordant therapy The patient intervention was a tailored behavioraleducation 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
There are 65 million Americans and over 85 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 behavioraleducation 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 patients visit The provider intervention was designed to improve guideline concordant therapy The patient intervention was a tailored behavioraleducation 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None