Evaluation of Integrating Self Blood Pressure Monitoring Into Urban Primary Care Practices

Study Overview
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Brief Summary
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Background: 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: Assess whether use of SBPM reduces elevated BP and increases HTN control to similar levels in two historically understudied minority populations, Blacks and Latinos. Confirm pilot findings by assessing the impact of SBPM on BP and HTN control compared to usual care using randomized controlled trial methodology. Develop standards and refine guidance for the effective use of SBPM that can be easily communicated to key stakeholders.

Official Title
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Evaluation of Integrating Self Blood Pressure Monitoring Into Urban Primary Care Practices to Improve Ethnic/ Racial Disparities in Hypertension

Conditions
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Hypertension, Cardiovascular Disease

Intervention / Treatment
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* Other: Home Blood Pressure Monitor Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients attending one of the participating primary care clinics 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: Arm circumference greater than 17.5 inches (maximum size of large BP cuff) Already monitoring BP at home at request of health care provider No access to a land line telephone line (to upload home readings)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br> | Other: Home Blood Pressure Monitor Group<br>* 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.<br>|
| No Intervention: Control<br>Participants receive usual care by providers. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute and relative changes in systolic and diastolic BP in the intervention and control groups. |  | 9 months | 
| Proportion of intervention participants achieving BP control compared to control participants |  | 9 months | 
| Trajectory of BP changes over time. |  | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Self Blood Pressure Monitoring, SBPM, Randomized Control Trial, Hypertension (HTN), Cardiovascular Disease (CVD), HTN, CVD