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Study to Lower Veterans BP: Patient/Physician Intervention

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00105716
First Posted: March 17, 2005
Last Update Posted: April 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose
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.

Condition Intervention
Hypertension Behavioral: Telephone behavioral education Behavioral: Computer behavioral education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Official Title: Study to Lower Veterans Blood Pressure: Patient/Physician Intervention

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • BP control at primary care visit; Systolic and diastolic BPs as recorded at each primary care provider visit during 24 month enrollment period.

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 544
Study Start Date: March 2002
Study Completion Date: April 2005
Arms Assigned Interventions
Arm 1 Behavioral: Telephone behavioral education Behavioral: Computer behavioral education

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. >1 ICD9 Diagnosis 401.0, 401.1, 401.9
  2. Designated Primary Care Provider
  3. >1 Primary Care visit between 1/01/01-12/31/01
  4. Restricted to NC and VA addresses
  5. >1 Medication CV100, CV150, CV200, CV490, CV701, CV702, CV704, CV800, CV805

Exclusion Criteria:

  1. Dialysis patient
  2. Hospitalization for stroke in prior 3 months
  3. Myocardial infarction in prior 3 months
  4. Coronary artery revascularization in prior 3 months
  5. Metastatic cancer diagnosis in prior 3 months
  6. Transplant of: kidney; liver; lung; pancreas; peripheral stem cells; bone; bone marrow; heart; intestine; stem cells; tissue V42.9; complications of transplants
  7. Nursing home resident
  8. Documented diagnosis of dementia
  9. Difficulty hearing
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00105716


Locations
United States, North Carolina
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Hayden B. Bosworth, PhD Durham VA Medical Center, Durham, NC
Principal Investigator: Eugene Z. Oddone, MD MHSc Durham VA Medical Center, Durham, NC
  More Information

Publications:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00105716     History of Changes
Other Study ID Numbers: IIR 20-034
First Submitted: March 16, 2005
First Posted: March 17, 2005
Last Update Posted: April 7, 2015
Last Verified: April 2006

Keywords provided by VA Office of Research and Development:
hypertension
adherence
cardiovascular diseases

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases