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

Hypertension Clinical Trial

— ESBPM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01123577
• Other study ID #: PCIP-CVD-ESBPM2010
• Status: Completed
• Phase: N/A
• First received: May 12, 2010
• Last updated: August 13, 2012
• Start date: May 2010
• Est. completion date: August 2012

Study information

• Verified date: August 2012
• Source: New York City Department of Health and Mental Hygiene
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 899
• Est. completion date: August 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Hypertension

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.

Locations

Country	Name	City	State
United States	Riverdale Family Practice	Bronx	New York
United States	Lutheran Family Health Centers	Brooklyn	New York
United States	Heritage Health Care	New York	New York
United States	New York City Department of Health and Mental Hygiene	New York	New York

Sponsors (5)

Lead Sponsor	Collaborator
New York City Department of Health and Mental Hygiene	Heritage Health Center (HHHNYC), New York City, New York University School of Medicine, Riverdale Family Practice, New York City, Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

References & Publications (4)

Agency for Healthcare Research and Quality. Utility of Blood Pressure Monitoring Outside the Clinic Setting: Agency for Healthcare Research and Quality; 2002.

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. — View Citation

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. Epub 2004 Jun 11. Erratum in: BMJ. 2004 Aug 28;329(7464):499. — View Citation

Taylor JR, Campbell KM. Home monitoring of glucose and blood pressure. Am Fam Physician. 2007 Jul 15;76(2):255-60. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute and relative changes in systolic and diastolic BP in the intervention and control groups.		9 months	No
Primary	Proportion of intervention participants achieving BP control compared to control participants		9 months	No
Primary	Trajectory of BP changes over time.		9 months	No