Hypertension Intervention Nurse Telemedicine Study (HINTS)

April 6, 2015 updated by: US Department of Veterans Affairs

Behavioral/Pharmacological Telemedicine Interventions for BP Control

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Detailed

Description 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 (<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 random sample of hypertensive patients with poor BP control at baseline were 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 is part of an extended primary care team and communicates 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.

Status:

Primary study enrollment began May 5, 2006 and was completed November 2007. We randomized 591 participants in the study. Baseline recruitment was completed in November 2007. Participants' completed the six month follow-up interviews in June 2008 and 12 month follow-up in December 2008. 18 month follow-up was completed June 2009.

Study was granted an extension to complete two goals: 1) investigate the sustainability of BP control after completion of intervention, and , 2) examine what aspects of the intervention worked or did not work using qualitative interviews.

Background/Rationale:

Despite the impact of hypertension and the availability of well-defined therapies and widely accepted target values for blood pressure (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. We received an 11 month extension to evaluate 3 key components of the study (sustainability of BP effects, qualitative evaluation of the intervention, evaluation of the supporting materials used to ensure literacy levels and cultural sensitivity.)

Methods:

A 4-arm randomized trial with 18-month follow-up. Patents were selected from primary care clinics at the Durham VA Medical Center. Of the eligible patients, 591 individuals were randomized to either usual care or one of three telephone-based intervention groups. The intervention phone calls were triggered based on home BP values transmitted via telemonitoring devices. Patients were instructed to take their BP three times a week and transmit to study team. Behavioral management involved promoting health behaviors. Medication management involved adjustment of hypertension medications by a study physician and nurse based on hypertension treatment guidelines. The primary outcome was changes in BP control measured at six-month intervals over 18 months. For the sustainability extension of the study, in additional to collection of BP values, we will use qualitative analysis to examine the audio interviews.

Status:

Sustainability phase recruitment began May 1, 2010 and ended on Aug 15, 2010. Analyses are continuing.

Study Type

Interventional

Enrollment (Actual)

591

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Durham VA Medical Center, Durham, NC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of uncontrolled hypertension,
  • prescribed a medication to lower blood pressure,
  • have a regular primary care physician at Durham VA Medical Center, and
  • be a veteran. For Sustainability portion the patient must have participated in an intervention arm of primary study.

Exclusion Criteria:

  • Hospitalized in past 3 months for stroke,
  • heart attack,
  • surgery for blocked arteries,
  • diagnosed with metastatic 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, and
  • creatinine serum lab which exceed 2.5.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Arm 1
Control group - a group of hypertensive patient who receive usual care
Experimental: Arm 2
Nurse Behavioral intervention with Home BP Telemonitoring Nurse-administered tailored behavior intervention
Behavioral: Nurse Behavioral intervention with Home BP Telemonitoring
Nurse-administered behavior intervention
Experimental: Arm 3
Nurse Medication Management with Home BP Telemonitoring -- Nurse administer medication management according to hypertension decision support system
Behavioral: Nurse Medication Management with Home BP Telemonitoring
Nurse administer medication management according to hypertension decision support
Experimental: Arm 4
Nurse Combined intervention with Home BP Telemonitoring - Combination of the nurse administered tailored behavioral & medication management interventions
Behavioral: Nurse Combined intervention with Home BP Telemonitoring
Combination of the nurse administered tailored behavioral & medication management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimated Percentage of Participants in Blood Pressure Control at Baseline
Time Frame: Baseline
When patients had multiple blood pressure readings during their baseline visit, means of their systolic and diastolic readings were used as the baseline blood pressure values; Using Joint National Committee 7 Report (JNC7) blood pressure guidelines for BP control: <140/90mmHg for non-diabetic patients and < 130/80mmHg for diabetic patients
Baseline
Estimated Percentage of Participants in Blood Pressure Control at 6 Months
Time Frame: 6month
When patients had multiple blood pressure readings during their 6 month visit, means of their systolic and diastolic readings were used as the 6 month blood pressure values; Using Joint National Committee 7 Report (JNC7) blood pressure guidelines for BP control: <140/90mmHg for non-diabetic patients and < 130/80mmHg for diabetic patients
6month
Estimated Percentage of Participants in Blood Pressure Control at 12 Months
Time Frame: 12 month
When patients had multiple blood pressure readings during their 12 month visit, means of their systolic and diastolic readings were used as the 12 month blood pressure values; Using Joint National Committee 7 Report (JNC7) blood pressure guidelines for BP control: <140/90mmHg for non-diabetic patients and < 130/80mmHg for diabetic patients
12 month
Estimated Percentage of Participants in Blood Pressure Control at 18 Months
Time Frame: 18 month
When patients had multiple blood pressure readings during their 18 month visit, means of their systolic and diastolic readings were used as the 18 month blood pressure values; Using Joint National Committee 7 Report (JNC7) blood pressure guidelines for BP control: <140/90mmHg for non-diabetic patients and < 130/80mmHg for diabetic patients
18 month
Blood Pressure Averages Systolic & Diastolic
Time Frame: Baseline

Blood pressure measured at Baseline.

BP control estimates are marginalized probabilities with corresponding 95% confidence intervals derived from a logistic mixed effects regression model.
Baseline
Blood Pressure Averages Systolic & Diastolic
Time Frame: 12-month

Blood pressure measured at 12 month.

BP control estimates are marginalized probabilities with corresponding 95% confidence intervals derived from a logistic mixed effects regression model.
12-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Department of Veterans Affairs

Investigators

  • Principal Investigator: Hayden B. Bosworth, PhD, Durham VA Medical Center, Durham, NC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

October 7, 2005

First Submitted That Met QC Criteria

October 7, 2005

First Posted (Estimate)

October 12, 2005

Study Record Updates

Last Update Posted (Estimate)

April 24, 2015

Last Update Submitted That Met QC Criteria

April 6, 2015

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIR 04-426

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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