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

Sponsored by:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00139490

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

MedlinePlus related topics: Heart Diseases High Blood Pressure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Home-Based Blood Pressure Interventions for African Americans

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

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
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental 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.
B: Active Comparator 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.
C: Placebo Comparator 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

Locations

United States, New York
Center for Home Care Policy & Research, Visiting Nurse Service of New York
New York, New York, United States, 10021

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator:

Penny H. Feldman, PhD

Center for Home Care Policy & Research, Visiting Nurse Service of New York

More Information

Responsible Party:	Visiting Nurse Service of New York ( Penny Feldman, PhD, Principal Investigator )
Study ID Numbers:	246, R01 HL78585
Study First Received:	August 29, 2005
Last Updated:	August 20, 2008
ClinicalTrials.gov Identifier:	NCT00139490
Health Authority:	United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):

Blood Pressure, High

Study placed in the following topic categories:

Heart Diseases
Vascular Diseases
Hypertension

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009