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 6, 2015
Last verified: August 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:
  • Estimated Percentage of Participants in Blood Pressure Control at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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

  • Estimated Percentage of Participants in Blood Pressure Control at 6 Months [ Time Frame: 6month ] [ Designated as safety issue: No ]
    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

  • Estimated Percentage of Participants in Blood Pressure Control at 12 Months [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    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

  • Estimated Percentage of Participants in Blood Pressure Control at 18 Months [ Time Frame: 18 month ] [ Designated as safety issue: No ]
    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

  • Blood Pressure Averages Systolic & Diastolic [ Time Frame: Baseline ] [ Designated as safety issue: No ]

    Blood pressure measured at Baseline.

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


  • Blood Pressure Averages Systolic & Diastolic [ Time Frame: 12-month ] [ Designated as safety issue: No ]

    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.



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 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

  Show Detailed Description

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Results First Received: August 29, 2014
Last Updated: April 6, 2015
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
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 26, 2015