Comparison of Two Programs to Improve Blood Pressure Treatment Adherence
Condition: Cardiovascular Diseases; Heart Diseases; Hypertension
MeSH terms: Hypertension; Cardiovascular Diseases; Heart Diseases
Study type: Interventional

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

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.
    

Intervention name(s): Nurse administered; BP Monitor
Intervention type(s): Behavioral; Device
Intervention description(s): Subjects received a nurse administered behavioral intervention via telephone every 8 weeks for 24 months.; Subjects received a study provided home BP monitor and recorded home BP 3 times per week for 24 months.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hypertension; Cariovascular Diseases; Health Illiteracy