NCT01162759

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
348

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 15, 2010

Completed
Last Updated

April 6, 2012

Status Verified

April 1, 2012

Enrollment Period

2 years

First QC Date

July 13, 2010

Last Update Submit

April 4, 2012

Conditions

Hypertension

Keywords

hypertension, intervention

Outcome Measures

Primary Outcomes (1)

  • BP at 6 months

    6 months

Study Arms (2)

Usual Care

NO INTERVENTION

The control group receiving usual care

Home Blood Pressure Monitoring Group

EXPERIMENTAL

Intervention group

Behavioral: Home Blood Pressure Monitoring

Interventions

Home Blood Pressure MonitoringBEHAVIORAL

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.

Also known as: HBPM
Home Blood Pressure Monitoring Group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Colorado, Institute of Health Research

Denver, Colorado, 80231, United States

Location

Related Publications (1)

  • 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.

    PMID: 23463811DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

4-(2-(4-hydroxybenzyl)-phenoxy)-N-methylbutylamine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • David J Magid, MD, MPH

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

  • Kari Olson, PharmD

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

  • Sarah J Billups, PharmD

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2010

First Posted

July 15, 2010

Study Start

July 1, 2008

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

April 6, 2012

Record last verified: 2012-04

Locations

US(1)