Comparison of Two Programs to Improve Blood Pressure Treatment Adherence

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

Detailed Description
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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.

Official Title
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Take Control of Your Blood Pressure (TCYB)

Conditions
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Cardiovascular Diseases, Heart Diseases, Hypertension

Intervention / Treatment
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* Behavioral: Nurse administered
* Device: BP Monitor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nurse administered<br>Nurse Administered Intervention: Subject received nurse administered behavioral intervention every 8 weeks via telephone for 24 months. | Behavioral: Nurse administered<br>* Subjects received a nurse administered behavioral intervention via telephone every 8 weeks for 24 months.<br>|
| Experimental: Nurse & BP monitor<br>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<br>* Subjects received a nurse administered behavioral intervention via telephone every 8 weeks for 24 months.<br>Device: BP Monitor<br>* Subjects received a study provided home BP monitor and recorded home BP 3 times per week for 24 months.<br>|
| No Intervention: Usual Care<br>Subjects received neither home BP monitor nor nurse phone intervention. | |
| Experimental: Home BP Monitor<br>Subject received study provided home BP monitor. Subject recorded home BP 3 times per week for 24 months. | Device: BP Monitor<br>* Subjects received a study provided home BP monitor and recorded home BP 3 times per week for 24 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BP measurement |  | Measured at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Cariovascular Diseases, Health Illiteracy