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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00139490 |
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 |
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Cardiovascular Diseases Heart Diseases Hypertension |
Behavioral: Health Education Program Behavioral: Basic Group Behavioral: Control Group |
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 |
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 |
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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.
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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.
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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.
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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.
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C: Placebo Comparator
Usual Care group
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Behavioral: Control Group
Usual Care
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Ages Eligible for Study: | 21 Years to 79 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
Center for Home Care Policy & Research, Visiting Nurse Service of New York | |
New York, New York, United States, 10021 |
Principal Investigator: | Penny H. Feldman, PhD | Center for Home Care Policy & Research, Visiting Nurse Service of New York |
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: | March 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00139490 History of Changes |
Health Authority: | United States: Federal Government |
Blood Pressure, High |
Heart Diseases Vascular Diseases Hypertension |
Heart Diseases Vascular Diseases Cardiovascular Diseases Hypertension |