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

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ClinicalTrials.gov Identifier: NCT00139490
Recruitment Status : Completed
First Posted : August 31, 2005
Last Update Posted : December 21, 2012
Sponsor:
Information provided by:
Visiting Nurse Service of New York

Brief Summary:
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 or disease Intervention/treatment Phase
Cardiovascular Diseases Heart Diseases Hypertension Behavioral: Health Education Program Behavioral: Basic Group Behavioral: Control Group Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 846 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Home-Based Blood Pressure Interventions for African Americans
Study Start Date : February 2006
Actual Primary Completion Date : May 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Documented adherence to nursing-specific practices that reflect and reinforce JNC7 guidelines [ Time Frame: Measured at 12 months ]
  2. Change in systolic and diastolic BP [ Time Frame: Measured at 12 months ]
  3. 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 ]
  4. Changes in systolic and diastolic Blood Pressure [ Time Frame: Measured at 12 months ]

Secondary Outcome Measures :
  1. Medication adherence [ Time Frame: Measured at 12 months ]
  2. Sodium intake [ Time Frame: Measured at 12 months ]
  3. Health care utilization [ Time Frame: Measured at 12 months ]
  4. Cost-effectiveness of the program [ Time Frame: Measured at 12 months ]


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Ages Eligible for Study:   21 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
R01HL078585 ( U.S. NIH Grant/Contract )
First Posted: August 31, 2005    Key Record Dates
Last Update Posted: December 21, 2012
Last Verified: December 2012

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

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases