HypertensionESBPMNCT01123577
Evaluation of Integrating Self Blood Pressure Monitoring Into Urban Primary Care Practices
A study testing Home Blood Pressure Monitor Group in people with Hypertension and Cardiovascular Disease, run by New York City Department of Health and Mental Hygiene at 4 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Cardiovascular Disease
- What is being tested?
- Home Blood Pressure Monitor Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 899 participants
- Where
- 4 sitesUnited States
- Study dates
- May 2010to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
4 sites in 1 country.
United States4 sites
Lutheran Family Health Centers
Brooklyn, New York, 11220
New York City Department of Health and Mental Hygiene
New York, New York, 10029
Heritage Health Care
New York, New York, 10031
Riverdale Family Practice
The Bronx, New York, 10463
About this study
Official title: Evaluation of Integrating Self Blood Pressure Monitoring Into Urban Primary Care Practices to Improve Ethnic/ Racial Disparities in Hypertension
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).
Read more
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.
- Conditions
- Hypertension, Cardiovascular Disease
- Being tested
- Home Blood Pressure Monitor Group
- Keywords
- Self Blood Pressure Monitoring, SBPM, Randomized Control Trial, Hypertension (HTN), Cardiovascular Disease (CVD), HTN, CVD
- Medical subject headings
- Hypertension, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Blood Pressure Monitor GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Other: Home Blood Pressure Monitor Group |
| Control | No intervention | Participants receive usual care by providers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute and relative changes in systolic and diastolic BP in the intervention and control groups.
Measured: 9 months
Proportion of intervention participants achieving BP control compared to control participants
Measured: 9 months
Trajectory of BP changes over time.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2010 (estimated)
- Study startMay 2010
- Primary completionJul 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 899 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York City Department of Health and Mental Hygiene
- Sponsor type
- Other government
- Collaborators
- Robert Wood Johnson Foundation, NYU Langone Health, Riverdale Family Practice, New York City, Heritage Health Center (HHHNYC), New York City
- Responsible party
- Principal investigator, Stella Yi, New York City Department of Health and Mental Hygiene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01123577
- Sponsor's protocol ID
- PCIP-CVD-ESBPM2010
- Acronym
- ESBPM
- Status last verified
- Aug 2012
- First submitted
- 12 May 2010
- Last updated
- 14 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15194600Angell 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.
PubMed 20031787Taylor JR, Campbell KM. Home monitoring of glucose and blood pressure. Am Fam Physician. 2007 Jul 15;76(2):255-60.
PubMed 17695570Agency 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.
PubMed 25737487
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Integrating Self Blood Pressure Monitoring Into Urban Primary Care Practices to Improve Ethnic/ Racial Disparities in Hypertension
- ClinicalTrials.gov ID
- NCT01123577
- Acronym / sponsor ID
- ESBPM / PCIP-CVD-ESBPM2010
- Conditions
- Hypertension, Cardiovascular Disease
- Keywords
- Self Blood Pressure Monitoring, SBPM, Randomized Control Trial, Hypertension (HTN), Cardiovascular Disease (CVD), HTN, CVD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 899 participants (actual)
- Lead sponsor
- New York City Department of Health and Mental HygieneOther government
- Collaborators
- Robert Wood Johnson Foundation, NYU Langone Health, Riverdale Family Practice, New York City, Heritage Health Center (HHHNYC), New York City
- Study start
- May 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 14 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Home Blood Pressure Monitor Group |
| Control | No intervention | –Participants receive usual care by providers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home Blood Pressure Monitor GroupParticipants 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. | Other | Intervention |
Primary outcome
Absolute and relative changes in systolic and diastolic BP in the intervention and control groups.
Time frame: 9 months
Proportion of intervention participants achieving BP control compared to control participants
Time frame: 9 months
Trajectory of BP changes over time.
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2012.
- Background: PubMed 15194600Cappuccio 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.
- Background: PubMed 20031787Angell 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.
- Background: PubMed 17695570Taylor JR, Campbell KM. Home monitoring of glucose and blood pressure. Am Fam Physician. 2007 Jul 15;76(2):255-60.
- BackgroundAgency for Healthcare Research and Quality. Utility of Blood Pressure Monitoring Outside the Clinic Setting: Agency for Healthcare Research and Quality; 2002.
- Derived from this study: PubMed 25737487Yi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Blood Pressure Monitor Group in people with Hypertension and Cardiovascular Disease, run by New York City Department of Health and Mental Hygiene at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute and relative changes in systolic and diastolic BP in the intervention and control groups. (time frame: 9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01123577, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2012.