Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
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: 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 November 20, 2014