Clinical Trial: Hypertension Intervention Nurse Telemedicine Study (HINTS)

This study is not yet open for patient recruitment.
Verified by Department of Veterans Affairs October 2005

Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00237692

Purpose

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 (less than 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.
Condition Intervention
Hypertesion
 Behavior: Nurse Behavioral intervention with Home Blood Pressure Telemonitoring - talored telephone care
 Behavior: Nurse Medication Management with Home Blood Pressure Telemonitoring - Tailored Telephone care
 Behavior: Nurse combined intervention with home blood pressure telemonitoring - tailored telephone care

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study

Official Title: Behavioral/Pharmacological Telemedicine Interventions for BP Control

Further study details as provided by Department of Veterans Affairs:
Primary Outcomes: Blood pressure control and medication adherence
Secondary Outcomes: Knowledge & perceived risks associated w/hypertension as determined by questionnaire; confidence w/hypertension regimen using a composite of 4 items; medication adherence (pill refill using calculated Med-out index for interventional period)
Expected Total Enrollment:  600

Study start: January 2006
Last follow-up: January 2006

Background:

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 (less than 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.

Objectives:

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.

Methods:

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=600) 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: greater than 140/90 mm/Hg (non-diabetic) and greater than 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.

Findings:

No results at this time.

Status:

Pilot testing of the measures and intervention algorithims is occurring.

Impact:

The proposed trial will also be one

Eligibility

Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

Diagnosis of uncontrolled hypertension, prescribed a medication to lower blood pressure, have a regular primary care physician at VA

Exclusion Criteria:

Hospitalized in past 3 months for stroke, heart attack, surgery for blocked arteries, diagnosed with metastic cancer or treated with dialysis. Have a diagnosis of dementia or a hearing impairment which prevents them from being able to hear/speak on the telephone.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00237692

Hayden B Bosworth, PhD      (919) 296-6936    boswo001@mc.duke.edu
Felicia A McCant    

North Carolina
      VA Medical Center, Durham,  North Carolina,  27705,  United States
Kathy L Weatherspoon  919-296-6936    weath009@mc.duke.edu 
Hayden B Bosworth, PhD  (919) 296-6936    boswo001@mc.duke.edu 
Hayden B. Bosworth, PhD,  Principal Investigator
Eugene Z. Oddone, MD MHSc,  Sub-Investigator

Study chairs or principal investigators

Hayden B. Bosworth, PhD,  Principal Investigator,  Department of Veterans Affairs   

More Information

Study ID Numbers:  IIR 04-426
Last Updated:  January 5, 2006
Record first received:  October 7, 2005
ClinicalTrials.gov Identifier:  NCT00237692
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-01-10

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