Home-Based Program to Treat High Blood Pressure in African Americans
Home-Based Blood Pressure Interventions for African Americans
2 other identifiers
interventional
846
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable cardiovascular-diseases
Started Feb 2006
Typical duration for not_applicable cardiovascular-diseases
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 29, 2005
CompletedFirst Posted
Study publicly available on registry
August 31, 2005
CompletedStudy Start
First participant enrolled
February 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedDecember 21, 2012
December 1, 2012
3.2 years
August 29, 2005
December 19, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Documented adherence to nursing-specific practices that reflect and reinforce JNC7 guidelines
Measured at 12 months
Change in systolic and diastolic BP
Measured at 12 months
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
Measured at 12 months
Changes in systolic and diastolic Blood Pressure
Measured at 12 months
Secondary Outcomes (4)
Medication adherence
Measured at 12 months
Sodium intake
Measured at 12 months
Health care utilization
Measured at 12 months
Cost-effectiveness of the program
Measured at 12 months
Study Arms (3)
A
EXPERIMENTALThe 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 COMPARATORThe 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 COMPARATORUsual Care group
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Severe heart failure
- Moderate to severe cognitive impairment
- Overall "poor" or "guarded" prognosis
- Life expectancy of less than 6 months from study entry
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Feldman PH, McDonald MV, Barron Y, Gerber LM, Peng TR. Home-based interventions for black patients with uncontrolled hypertension: a cluster randomized controlled trial. J Comp Eff Res. 2016 Mar;5(2):155-68. doi: 10.2217/cer.15.60. Epub 2016 Mar 7.
PMID: 26946952DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Penny H. Feldman, PhD
Center for Home Care Policy & Research, Visiting Nurse Service of New York
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 29, 2005
First Posted
August 31, 2005
Study Start
February 1, 2006
Primary Completion
May 1, 2009
Study Completion
September 1, 2009
Last Updated
December 21, 2012
Record last verified: 2012-12