Behavioral Study to Control Blood Pressure
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      We propose to test an intervention to increase patients' understanding of the causes,
      consequences, and the rationale for treatment, of their hypertension (HTN), as a strategy for
      increasing blood pressure (BP) control. The focus is on the interaction between a behavioral
      intervention to reduce BP - home BP monitoring (HBPM) - and patient knowledge, which, we
      propose, moderates the effect of the HBPM intervention. We hypothesize that patients who have
      a better understanding of their illness and its prescribed treatment will be more adherent to
      the treatment regimen, and thus will exhibit improved outcomes compared to those who have
      been exposed to the same intervention, but who do not have a clear understanding of these
      elements.
    

Detailed description: 
      According to the National Health and Nutrition Examination Survey, more than 31% of adults in
      the U.S. population have hypertension (HTN). HTN is a major risk factor for heart disease and
      stroke, which are the 1st and 3rd leading causes of death in the U.S. and impose an enormous
      financial and social burden on Americans with more than $352 billion spent in direct and
      indirect costs. Behavioral interventions to control blood pressure (BP) have exhibited, on
      average, positive but relatively modest effects on blood pressure control. We and others have
      studied the effects of one such intervention - home BP monitoring - on BP control in
      hypertensive patients, and found reliable, albeit modest effects. We have found similar
      effects for another behavioral intervention, Motivational Interviewing, on BP control. We
      hypothesize that the effects of such interventions will be augmented when accompanied by a
      systematic approach to patient education concerning their illness and its treatment. The
      literature suggests that patient education is "necessary but not sufficient"(an implicit
      interaction) to produce behavioral changes; however, the "necessary" part tends to be ignored
      by interventionalists. The implication of the interaction is that when patients lack the
      necessary knowledge, any intervention is likely to be less effective (as any value multiplied
      by zero - i.e., no knowledge - is zero). In spite of this, we have found no trials that have
      tested the interaction between patient knowledge and a lifestyle or drug intervention.

      We propose to test an intervention to increase patients' understanding of the causes,
      consequences, and the rationale for treatment, of their HTN, as a strategy for increasing BP
      control. The focus is on the interaction between a behavioral intervention to reduce BP -
      home BP monitoring (HBPM) - and patient knowledge, which, we propose, moderates the effect of
      the HBPM intervention. We hypothesize that patients who have a better understanding of their
      illness and its prescribed treatment will be more adherent to the treatment regimen, and thus
      will exhibit improved outcomes compared to those who have been exposed to the same
      intervention, but who do not have a clear understanding of these elements.

      We propose to pilot test the effect of the HBPM intervention using a 2 X 2 independent groups
      randomized design, to allow us to compare the effects of Usual Care (UC) + Printed Materials
      (PM) compared to Usual Care (UC) and Self-Paced Programmed Instruction (SPPI) compared to
      Home Blood Pressure Monitoring (HBPM) + Printed Materials (PM) compared to Home Blood
      Pressure Monitoring (HBPM) + Self-Paced Programmed Instruction (SPPI).

      Our primary hypothesis is:

      Decreased ABP at 3 months will be ordered thusly:

      HBPM+SPPI > HBPM+PM > UC+SPPI > UC+PM
    

Intervention name(s): Self-Paced Programmed Instruction (SPPI); Home Blood Pressure Monitor; Usual Care; Printed Materials
Intervention type(s): Other; Other; Other; Other
Intervention description(s): If participants are assigned to SPPI, they will be asked to complete a series of educational modules at their own pace on the laptop that is provided. They will be informed that there is no grading and that the program is set up so that they can go at their own pace. The SPPI modules will be designed directly from the information provided on the Printed Materials (PM) from the National Institutes of Health.; The home blood pressure monitor will allow the participant to measure their blood pressure anytime and anywhere precisely, quickly and easily on their upper arm.; Standard care; National Institutes of Health Printed Materials on hypertension
Other intervention name(s): Carrera Upper Arm Blood Pressure Monitor (battery opperated); NIH publications 96-4041, 4042, 4045, 4046, 4047
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: high blood pressure