Hypertension Intervention Nurse Telemedicine Study (HINTS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00237692
First received: October 7, 2005
Last updated: April 15, 2014
Last verified: April 2014
  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
Hypertension
Behavioral: Nurse Behavioral intervention with Home BP Telemonitoring
Behavioral: Nurse Medication Management with Home BP Telemonitoring
Behavioral: Nurse Combined intervention with Home BP Telemonitoring

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Behavioral/Pharmacological Telemedicine Interventions for BP Control

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Blood pressure control and medication adherence [ Time Frame: Blood pressure measured at 6mo intervals, baseline, 6mo, 12 mo, & 18 mo ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) [ Time Frame: Surveys administered at 6 mo intervals, baseline, 6mo, 12 mo, & 18 mo ] [ Designated as safety issue: No ]
  • Blood pressure control sustainability [ Time Frame: 6 mo-2 years after primary study completion ] [ Designated as safety issue: No ]
  • Intervention efficacy through process evaluation for understanding [ Time Frame: Questionnaire administered at follow-up appt 6 mo - 2 years after primary study completion ] [ Designated as safety issue: No ]

Enrollment: 591
Study Start Date: May 2006
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Arm 1
Control group - a group of hypertensive patient who receive usual care
Experimental: Arm 2
Nurse-administered behavior intervention
Behavioral: Nurse Behavioral intervention with Home BP Telemonitoring
Nurse-administered behavior intervention
Experimental: Arm 3
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
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

  Hide Detailed Description

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 (n=609) 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 593 participants in the study. There are 544 males and 49 females enrolled. 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 with 518 (87%) participants completed the 18-month BP follow-up. We have had 24 participants' withdraw from the study, 8 died during the study and 23 were excluded after randomization.

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. We anticipate recruitment beginning in April 2010. We expect it will take 3 months to complete.

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 1551 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.

IMPACT:

Each intervention group demonstrated improvements in BP control or systolic BP at 12 months, but the improvements were not sustained at 18 months. None of the intervention groups increased health care use and the cost of the interventions was approximately $1,200 per patient over 18 months. Further work is required to identify individuals who will likely most benefit from this more intensive model of behavioral and medication management interventions in non-clinical settings

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00237692

Locations
United States, North Carolina
Durham VA Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Investigators
Principal Investigator: Hayden B. Bosworth, PhD Department of Veterans Affairs
  More Information

Publications:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00237692     History of Changes
Other Study ID Numbers: IIR 04-426
Study First Received: October 7, 2005
Last Updated: April 15, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Telemedicine
Adherence
Tailored Nurse Intervention
Home Blood Pressure Monitoring
cardiovascular disease

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 21, 2014