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

New York City Department of Health and Mental Hygiene

Status: Completed

Conditions: Hypertension; Cardiovascular Disease

Treatments: Other: Home Blood Pressure Monitor Group

Study type: Interventional

Funder types: Other

Identifiers

NCT01123577

PCIP-CVD-ESBPM2010

Details and patient eligibility

About

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:

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.

Enrollment: 899 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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899 participants in 2 patient groups

Intervention

Experimental group

Treatment:

Other: Home Blood Pressure Monitor Group

Control

No Intervention group

Description:

Participants receive usual care by providers.