Comparison of Two Programs to Improve Blood Pressure Treatment Adherence

September 5, 2014 updated by: Duke University

Take Control of Your Blood Pressure (TCYB)

The purpose of this study is to improve adherence to blood pressure (BP) monitoring and medication compliance in individuals with high BP.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND:

High BP is a major health problem, which contributes to high levels of morbidity and mortality. Elevated BP levels are a major risk factor for stroke, coronary artery disease (CAD), congestive heart failure (CHF), and kidney disease. In the United States, stroke rates are no longer improving and CHF and kidney failure rates continue to increase. Despite the availability of effective treatment, only 25% of individuals with high BP are able to control it effectively. The reasons for poor BP control vary; however, a predominant reason is poor adherence to medication instructions and life-style modification recommendations. This study will address these two sources of poor BP control through a real world, multifaceted approach.

DESIGN NARRATIVE:

This study will compare a nurse-administered tailored program to a home BP monitoring program to evaluate the impact each program has on BP control. The 5-year randomized controlled study will take place in a primary care setting and will enroll individuals with high BP. The nurse-administered program will be based on the principles of the Health Decision Model and will be designed to increase awareness, yet be easily integrated into the participant's medical care so as to enhance adherence with the prescribed treatment. The use of home BP monitors has been found to be associated with increased self management, medication adherence, and improved BP control.

Five hundred seventy individuals with high BP from two primary care clinics will be randomly assigned to receive either the nurse-administered program, home BP monitoring program, both programs, or regular medical care. Based on an initial assessment, participants assigned to the nurse-administered program will be involved in a behavioral education telephone program to promote medication adherence. This program will include support, reminders, and information on the risks of high BP, health behaviors, patient/doctor communication, literacy, and side effects. Participants will receive continuous education and will be monitored and supported to enhance medication adherence. Participants assigned to the home BP monitors will record their BP every other day and mail the results to the study physicians. The primary outcome will be whether or not the participant's BP is greater than 140/90 mm Hg (for non-diabetic individuals) or greater than 130/85 mm Hg (for diabetic individuals) at 6-month intervals over 24 months (5 total measurements). Descriptive statistics will be computed for all study variables stratified by treatment group. Because each participant may have a different number of measurements, the study physicians will model the responses and evaluate the programs using a mixed effects model for dichotomous outcomes. Based upon preliminary data, this study will improve participants' management of high BP, decrease health care utilization, and subsequently improve BP control.

Additionally, a subset (n=250) of those enrolled and randomized to either the nurse administered program or usual care will be evaluated separately on the programs's effect on both primary (blood pressure control) and secondary outcome measures (changes in hypertension risk perception,satisfaction with care, patient confidence following recommended regimen, and self-reported adherence to recommended regimens.) Masking for this is open label.

Study Type

Interventional

Enrollment (Actual)

777

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Visited Duke General Internal Medicine Primary Care Clinic at Pickett Road or Duke Outpatient Clinic between April 2003 and April 2004
  • Diagnosed with high BP
  • Currently residing in an eight county area, including Durham County, NC and surrounding counties
  • Currently taking BP medication
  • Receives most medical care at the Duke Primary Care clinics
  • Able to speak and understand English over the phone

Exclusion Criteria:

  • Diagnosed with dementia
  • Diagnosed with Parkinson's Disease
  • Diagnosed with atrial fibrillation
  • Diagnosed with end stage kidney disease
  • Hospitalized for stroke, heart attack, or coronary artery revascularization in the 3 months prior to study entry
  • Diagnosed with metastatic cancer in the 3 months prior to study entry
  • Receiving kidney dialysis
  • Pregnant or expecting to become pregnant in the 2 years following study entry
  • Currently residing in a nursing home or receiving home health care
  • Severely impaired speech or hearing
  • Participating in another blood pressure study
  • Has another family member participating in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nurse administered

Nurse Administered Intervention:

Subject received nurse administered behavioral intervention every 8 weeks via telephone for 24 months.
Behavioral: Nurse administered
Subjects received a nurse administered behavioral intervention via telephone every 8 weeks for 24 months.
Experimental: Nurse & BP monitor
Subjects received both a nurse administered behavioral intervention via telephone every 8 weeks for 24 months and a study provided home BP monitor. Subject recorded home BP 3 times per week for 24 months.
Behavioral: Nurse administered
Subjects received a nurse administered behavioral intervention via telephone every 8 weeks for 24 months.
Device: BP Monitor
Subjects received a study provided home BP monitor and recorded home BP 3 times per week for 24 months.
No Intervention: Usual Care
Subjects received neither home BP monitor nor nurse phone intervention.
Experimental: Home BP Monitor
Subject received study provided home BP monitor. Subject recorded home BP 3 times per week for 24 months.
Device: BP Monitor
Subjects received a study provided home BP monitor and recorded home BP 3 times per week for 24 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
BP measurement
Time Frame: Measured at 6 months
Measured at 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Satisfaction with care
Time Frame: Measured at 6 and 24 months
Measured at 6 and 24 months
Risk associated with hypertension
Time Frame: Measured at 6 and 24 months
Measured at 6 and 24 months
Self reported adherence
Time Frame: Measured at 6 and 24 months
Measured at 6 and 24 months
Efficacy with treatment
Time Frame: Measured at 6 and 24 months
Measured at 6 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
Pfizer

Investigators

  • Principal Investigator: Hayden B. Bosworth, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

July 20, 2005

First Submitted That Met QC Criteria

July 20, 2005

First Posted (Estimate)

July 22, 2005

Study Record Updates

Last Update Posted (Estimate)

September 8, 2014

Last Update Submitted That Met QC Criteria

September 5, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00005845
  • R01HL070713 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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