Home Blood Pressure Monitoring Project

NCT ID: NCT01162759

Last Updated: 2012-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

348 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-07-31

Brief Summary

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The goal of this project is to improve hypertension control at Kaiser Permanente Colorado (KPCO) by implementing a population-based multi-factorial intervention that uses home BP monitors that can download BP readings to KPCO's health records via internet, interactive voice response (IVR) technology, and multidisciplinary care team. Participants will be randomized to either the home blood pressure monitoring group receiving the multi-factorial intervention or the usual care group who will be receiving Kaiser standard of care. We will determine the proportion of patients in each group who achieve their target BP goals at 6 months, according to national clinical practice guidelines. The study hypothesis is that a higher proportion of patients with uncontrolled hypertension in the home blood pressure monitoring (HBPM) group will achieve their target blood pressure compared to those in the usual care (UC) group.

Detailed Description

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STUDY OBJECTIVES:

Primary:

• To determine the proportion of patients in each group who achieve their target BP goals at 6 months, according to national clinical practice guidelines

Secondary:

The following parameters will be evaluated between groups:

* Change in BP measures between baseline and at 6 months
* Proportion of patients who are receiving antihypertensive treatments in accordance to national clinical practice guidelines
* Adherence to hypertensive medication regimen during the 6-month follow-up period
* Patient satisfaction with the care model.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Usual Care

The control group receiving usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Home Blood Pressure Monitoring Group

Intervention group

Group Type EXPERIMENTAL

Home Blood Pressure Monitoring

Intervention Type BEHAVIORAL

Home blood pressure readings are taken at least 3 times a week, uploaded to a Microsoft Health Vault account through American Heart Association Heart360 at least 1 time per week. Patients are followed by a clinical pharmacist, with physician oversight, who will make adjustments to antihypertensive medications or suggest additional medications using national JNC VII and KPCO hypertension guidelines.

Interventions

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Home Blood Pressure Monitoring

Home blood pressure readings are taken at least 3 times a week, uploaded to a Microsoft Health Vault account through American Heart Association Heart360 at least 1 time per week. Patients are followed by a clinical pharmacist, with physician oversight, who will make adjustments to antihypertensive medications or suggest additional medications using national JNC VII and KPCO hypertension guidelines.

Intervention Type BEHAVIORAL

Other Intervention Names

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HBPM

Eligibility Criteria

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Inclusion Criteria

* Age 18 to 85 years At least 1 diagnosis for hypertension,

* Receive primary care from one of the participating clinics,
* The two most recent BPs documented within that last 24 months are elevated (SBP\>140 and/or DBP\>90)
* Receiving \< 3 antihypertensive medications, and
* Have access to a computer with a USB port.

Exclusion Criteria

* Pregnant, or breast-feeding,
* Patients on dialysis or being followed by nephrology,
* Patients with coronary artery disease, given these patients are already followed by the Clinical Pharmacy Cardiac Risk Service (CPCRS),
* On KPCO "Do Not Call" or deceased list,
* PCP does not give permission to include patient in the study,
* BP is at or below target at the baseline study visit,
* Not English-speaking.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Heart Association

OTHER

Sponsor Role collaborator

Kaiser Permanente

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David J Magid, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Kari Olson, PharmD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Sarah J Billups, PharmD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

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Kaiser Permanente Colorado, Institute of Health Research

Denver, Colorado, United States

Site Status

Countries

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United States

References

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Magid DJ, Olson KL, Billups SJ, Wagner NM, Lyons EE, Kroner BA. A pharmacist-led, American Heart Association Heart360 Web-enabled home blood pressure monitoring program. Circ Cardiovasc Qual Outcomes. 2013 Mar 1;6(2):157-63. doi: 10.1161/CIRCOUTCOMES.112.968172. Epub 2013 Mar 5.

Reference Type DERIVED
PMID: 23463811 (View on PubMed)

Other Identifiers

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CO-08DMagi-01

Identifier Type: -

Identifier Source: org_study_id

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