Comparison of Two Programs to Improve Blood Pressure Treatment Adherence

Sponsor

Duke University (Other)

Overall Status

Completed

CT.gov ID

NCT00123058

Collaborator

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

777

Enrollment

Location

Arms

Duration (Months)

16.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases Heart Diseases Hypertension	Behavioral: Nurse administered Device: BP Monitor	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

777 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Take Control of Your Blood Pressure (TCYB)

Study Start Date :

Jun 1, 2003

Actual Primary Completion Date :

Dec 1, 2005

Actual Study Completion Date :

Jun 1, 2007

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

BP measurement [Measured at 6 months]

Secondary Outcome Measures

Satisfaction with care [Measured at 6 and 24 months]
Risk associated with hypertension [Measured at 6 and 24 months]
Self reported adherence [Measured at 6 and 24 months]
Efficacy with treatment [Measured at 6 and 24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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