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

Sponsor

New York City Department of Health and Mental Hygiene (Other)

Overall Status

Completed

CT.gov ID

NCT01123577

Collaborator

Robert Wood Johnson Foundation (Other), NYU Langone Health (Other), Riverdale Family Practice, New York City (Other), Heritage Health Center (HHHNYC), New York City (Other)

899

Enrollment

Locations

Arms

Duration (Months)

224.8

Patients Per Site

8.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension Cardiovascular Disease	Other: Home Blood Pressure Monitor Group	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

899 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2010

Actual Primary Completion Date :

Jul 1, 2012

Actual Study Completion Date :

Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention	Other: 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.
No Intervention: Control Participants receive usual care by providers.

Arm

Intervention/Treatment

Experimental: Intervention

Other: 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.

No Intervention: Control

Participants receive usual care by providers.

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Riverdale Family Practice	Bronx	New York	United States	10463
2	Lutheran Family Health Centers	Brooklyn	New York	United States	11220
3	New York City Department of Health and Mental Hygiene	New York	New York	United States	10029
4	Heritage Health Care	New York	New York	United States	10031