Home-Based Program to Treat High Blood Pressure in African Americans

This study has been completed.
Sponsor:
Information provided by:
Visiting Nurse Service of New York
ClinicalTrials.gov Identifier:
NCT00139490
First received: August 29, 2005
Last updated: December 19, 2012
Last verified: December 2012
  Purpose

The purpose of this study is to examine the effectiveness and cost effectiveness of two organizational interventions aimed at improving blood pressure (BP) control among a high-risk, African American home care population.


Condition Intervention
Cardiovascular Diseases
Heart Diseases
Hypertension
Behavioral: Health Education Program
Behavioral: Basic Group
Behavioral: Control Group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Home-Based Blood Pressure Interventions for African Americans

Resource links provided by NLM:


Further study details as provided by Visiting Nurse Service of New York:

Primary Outcome Measures:
  • Documented adherence to nursing-specific practices that reflect and reinforce JNC7 guidelines [ Time Frame: Measured at 12 months ] [ Designated as safety issue: No ]
  • Change in systolic and diastolic BP [ Time Frame: Measured at 12 months ] [ Designated as safety issue: No ]
  • Proportion of patients that are below the target home BP levels (135/85 mm Hg for non-diabetic and kidney disease participants; 125/75 mm Hg for diabetic and kidney disease participants [ Time Frame: Measured at 12 months ] [ Designated as safety issue: No ]
  • Changes in systolic and diastolic Blood Pressure [ Time Frame: Measured at 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Medication adherence [ Time Frame: Measured at 12 months ] [ Designated as safety issue: No ]
  • Sodium intake [ Time Frame: Measured at 12 months ] [ Designated as safety issue: No ]
  • Health care utilization [ Time Frame: Measured at 12 months ] [ Designated as safety issue: No ]
  • Cost-effectiveness of the program [ Time Frame: Measured at 12 months ] [ Designated as safety issue: No ]

Enrollment: 846
Study Start Date: February 2006
Study Completion Date: September 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
The augmented intervention will consist of just-in-time nurse, patient and physician information and feedback during the post-acute period, plus transition to an ongoing Home-Based HTN Support Program within approximately 30 days after the patient's admission to home health care. The augmented intervention adds an HTN Nurse Specialist (advanced practice nurse) and a lay community health worker, who will be responsible for assuring a patient's smooth transition to the Home-Based HTN Support Program and for delivering the main components of that intervention, backed up by the project physician.
Behavioral: Health Education Program
The augmented intervention will consist of just-in-time nurse, patient and physician information and feedback during the post-acute period, plus transition to an ongoing Home-Based HTN Support Program within approximately 30 days after the patient's admission to home health care. The augmented intervention adds an HTN Nurse Specialist (advanced practice nurse) and a lay community health worker, who will be responsible for assuring a patient's smooth transition to the Home-Based HTN Support Program and for delivering the main components of that intervention, backed up by the project physician.
Active Comparator: B
The basic information and referral intervention will deliver key "just-in-time" information to nurses, patients and patients' physicians while the patient is receiving post-acute home care services. The basic intervention relies on care provided by home health nurses during the routine home health stay.
Behavioral: Basic Group
The basic information and referral intervention will deliver key "just-in-time" information to nurses, patients and patients' physicians while the patient is receiving post-acute home care services. The basic intervention relies on care provided by home health nurses during the routine home health stay.
Placebo Comparator: C
Usual Care group
Behavioral: Control Group
Usual Care

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • African American
  • Have uncontrolled hypertension, defined as BP greater than 140/90 mm Hg (systolic, diastolic, or both), and 130/80 mm Hg for individuals with diabetes or kidney failure

Exclusion Criteria:

  • Severe heart failure
  • Moderate to severe cognitive impairment
  • Overall "poor" or "guarded" prognosis
  • Life expectancy of less than 6 months from study entry
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00139490

Sponsors and Collaborators
Visiting Nurse Service of New York
Investigators
Principal Investigator: Penny H. Feldman, PhD Center for Home Care Policy & Research, Visiting Nurse Service of New York
  More Information

No publications provided

Responsible Party: Penny Feldman, PhD, Principal Investigator, Visiting Nurse Service of New York
ClinicalTrials.gov Identifier: NCT00139490     History of Changes
Other Study ID Numbers: 246, R01 HL78585
Study First Received: August 29, 2005
Last Updated: December 19, 2012
Health Authority: United States: Federal Government

Keywords provided by Visiting Nurse Service of New York:
Blood Pressure, High

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Hypertension
Vascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014