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BEHAVIORAL/PHARMACOLOGICAL TELEMEDICINE INTERVENTIONS FOR BP CONTROL
Project Number IIR 04-426 funded
by HSR&D.
August 1, 2005 -
September 30, 2008
There are 65 million Americans and over 8.5 million veterans who have been diagnosed with hypertension; yet only 31% of all hypertensive patients have their blood pressure (BP) under effective control (<140/90 mm/Hg). Uncontrolled hypertension greatly increases the risk of cerebral vascular accidents, coronary artery disease, myocardial infarction, renal failure, congestive heart failure, and mortality. Despite the damaging impact of hypertension and the availability of well-defined therapies and widely accepted target values for BP, interventions to improve BP control have had limited success.
The study is one of the first to compare three interventions designed to improve BP control: a behavioral educational intervention, an evidence-based medication management intervention, and combined intervention for patients with poor BP control defined by home BP monitoring. The primary hypotheses are: 1) Patients who receive only the behavioral intervention will show improved rates of BP control as compared to the control group over 18 months of follow-up; 2) Patients who receive only the hypertension medication management intervention will show improved rates of BP control as compared to the control group over 18 months of follow-up; and, 3) Patients who receive the combined intervention will show higher rates of BP control as compared to all other patients over the 18 months of follow-up.
A three-year randomized controlled trial among veterans with poor BP control testing three interventions in three VA primary care clinics is proposed to improve BP control. We will test these interventions using home BP monitoring in a four group design administered via the telephone: 1) control group - a group of hypertensive patients who receive usual care; 2) Nurse-administered tailored behavioral intervention previously tested (HSR&D grant IIR 20-034); 3) Nurse-administered medication management according to a hypertension decision support system that uses the VA’s Computerized Medical Record System (VA HSR&D grant CPI 99275); 4) combination of the tailored behavioral and medication management interventions.
A sample of hypertensive patients with poor BP control at baseline (n=620) will be consented and randomly allocated to one of four arms. The interventions will activate only when home BP monitoring indicates inadequate BP control. Patients assigned to the behavioral intervention will receive a tailored self-management intervention to promote adherence with medication, information on the risks of hypertension and health behaviors at periodic telephone contacts. Patients will receive feedback about their recent BP values, continuous patient education, and will be monitored and supported to enhance treatment adherence. Patients randomized to the medication management arm will have their hypertension regimen changed by a nurse using a hypertension decision support system developed and validated in the VA. Medication recommendations generated are based on JNC 7 and the VA’s hypertension treatment guidelines and are also individualized to patients’ comorbid illnesses, laboratory values, and other elements of patients’ clinical status. Medication management will be based on home BP monitoring and delivered by telephone. The nurse will be part of an extended primary care team and will communicate changes to the patients’ primary care providers via a study physician.
The primary outcome will be a dichotomous measure representing whether or not the patient’s BP is in control: >140/90 mm/Hg (non-diabetic) and >130/80 mm/Hg (diabetics). Measures will be made at six-month intervals over 18 months (4 total measurements). We will model the outcome measures and evaluate the interventions using a mixed effects model for dichotomous outcomes.
In October 05, among 20 individuals, we pilot tested the feasibility of the telemedicine devices, and the reliablity of the blood pressure readings. Results indicated that patients were able to use the equipment and the devices were reliable. We have no results at this time regarding the primary study.
Primary study enrollment began May 5,2006. Currently, we have enrolled 436 participants in the study. There are 396 males and 40 females enrolled. 187 participants have completed the 6 month follow-up interview, while 22 have completed the 12 month follow-up interview. Fifty percent of the current enrollment are minority participants. We have had 9 participants withdraw since the enrollment began.
The proposed trial will also be one of the first to use non-clinic based telecommunications to activate an intervention and monitor its effects. Added benefits of this study will include monitoring and treatment algorithms that can be translated into VA primary care clinics should they prove to be effective.
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