Study to Lower Veterans BP: Patient/Physician Intervention

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00105716
First received: March 16, 2005
Last updated: October 25, 2013
Last verified: April 2006
  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
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Official Title: Study to Lower Veterans Blood Pressure: Patient/Physician Intervention

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

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. [ Designated as safety issue: No ]

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 [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00105716

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

Publications:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00105716     History of Changes
Other Study ID Numbers: IIR 20-034
Study First Received: March 16, 2005
Last Updated: October 25, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
hypertension
adherence
cardiovascular diseases

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014