Evaluation of Integrating Self Blood Pressure Monitoring Into Urban Primary Care Practices
NCT ID: NCT01123577
Last Updated: 2012-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
899 participants
INTERVENTIONAL
2010-05-31
2012-08-31
Brief Summary
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Hypertension (HTN) is a major risk factor for cardiovascular disease (CVD), the leading cause of death in the United States and New York City (NYC). One in 4 NYC adults has hypertension, with higher prevalence in both Blacks and Latinos compared to Whites (Angell 2008). In NYC, only 65% of all adults with HTN and on treatment are controlled (Angell 2008).
Self-blood pressure monitoring (SBPM) is associated with reduced blood pressure in patients with hypertension (Cappuccio 2004). Studies suggest that SBPM may increase control either by inducing clinicians to titrate medication more actively, (Agency for Healthcare Research and Quality 2002) by engaging patients to participate in their own health care, (Taylor 2007) or a combination of the two.
However, minimal research has been done to evaluate the effectiveness of SBPM in different racial and/or ethnic groups or in low income populations or to discern effective patterns of SBPM use by patients. Best practices for integration of self monitoring into HTN into regular treatment have also yet to be established.
Objectives:
The goal of this study is to assess the impact of SBPM under conditions consistent with existing community health clinic resources and infrastructure in NYC's medically underserved neighborhoods using commonly available automated home BP monitors. By using a community clinic's electronic health record (EHR) and automated BP monitors with the capability to transmit readings to a research database, we can facilitate a more rigorous evaluation of a pilot SBPM intervention and assess patterns of home monitor use and clinical management and their association with outcomes.
The three specific aims of this intervention are to:
1. Assess whether use of SBPM reduces elevated BP and increases HTN control to similar levels in two historically understudied minority populations, Blacks and Latinos.
2. Confirm pilot findings by assessing the impact of SBPM on BP and HTN control compared to usual care using randomized controlled trial methodology.
3. Develop standards and refine guidance for the effective use of SBPM that can be easily communicated to key stakeholders.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention
Home Blood Pressure Monitor Group
Participants receive home monitors, modems, educational materials and training. Participants will send home BP readings to research database monthly and receive usual care by providers for 9 months.
Control
Participants receive usual care by providers.
No interventions assigned to this group
Interventions
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Home Blood Pressure Monitor Group
Participants receive home monitors, modems, educational materials and training. Participants will send home BP readings to research database monthly and receive usual care by providers for 9 months.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of hypertension for at least 6 months
* Ethnicity or Race of Latino, Black or White
* Physically and mentally able to monitor BP at home
* \*Uncontrolled BP at last office visit
* \*Uncontrolled BP at current office visit
Note: \*Uncontrolled BP is defined as systolic BP ≥ 140 and/or diastolic BP ≥ 90, or systolic BP ≥ 130 and/or diastolic BP ≥ 80 mm Hg for participants with chronic kidney disease or diabetes.
Exclusion Criteria
* Already monitoring BP at home at request of health care provider
* No access to a land line telephone line (to upload home readings)
18 Years
ALL
No
Sponsors
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Robert Wood Johnson Foundation
OTHER
NYU Langone Health
OTHER
Riverdale Family Practice, New York City
UNKNOWN
Heritage Health Center (HHHNYC), New York City
UNKNOWN
New York City Department of Health and Mental Hygiene
OTHER_GOV
Responsible Party
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Stella Yi
Principal Investigator
Locations
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Lutheran Family Health Centers
Brooklyn, New York, United States
New York City Department of Health and Mental Hygiene
New York, New York, United States
Heritage Health Care
New York, New York, United States
Riverdale Family Practice
The Bronx, New York, United States
Countries
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References
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Cappuccio FP, Kerry SM, Forbes L, Donald A. Blood pressure control by home monitoring: meta-analysis of randomised trials. BMJ. 2004 Jul 17;329(7458):145. doi: 10.1136/bmj.38121.684410.AE. Epub 2004 Jun 11.
Angell SY, Garg RK, Gwynn RC, Bash L, Thorpe LE, Frieden TR. Prevalence, awareness, treatment, and predictors of control of hypertension in New York City. Circ Cardiovasc Qual Outcomes. 2008 Sep;1(1):46-53. doi: 10.1161/CIRCOUTCOMES.108.791954.
Taylor JR, Campbell KM. Home monitoring of glucose and blood pressure. Am Fam Physician. 2007 Jul 15;76(2):255-60.
Agency for Healthcare Research and Quality. Utility of Blood Pressure Monitoring Outside the Clinic Setting: Agency for Healthcare Research and Quality; 2002.
Yi SS, Tabaei BP, Angell SY, Rapin A, Buck MD, Pagano WG, Maselli FJ, Simmons A, Chamany S. Self-blood pressure monitoring in an urban, ethnically diverse population: a randomized clinical trial utilizing the electronic health record. Circ Cardiovasc Qual Outcomes. 2015 Mar;8(2):138-45. doi: 10.1161/CIRCOUTCOMES.114.000950. Epub 2015 Mar 3.
Other Identifiers
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PCIP-CVD-ESBPM2010
Identifier Type: -
Identifier Source: org_study_id