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Home Blood Pressure Monitoring Project (HBPM)

This study has been completed.
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT01162759
First received: July 13, 2010
Last updated: April 4, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention
Hypertension
 Behavioral: Home Blood Pressure Monitoring

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Home Blood Pressure Monitoring Program

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • BP at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 348
Study Start Date: July 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual Care
The control group receiving usual care
Experimental: Home Blood Pressure Monitoring Group
Intervention group
 Behavioral: 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.
Other Name: HBPM

Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01162759

Locations
United States, Colorado
Kaiser Permanente Colorado, Institute of Health Research
Denver, Colorado, United States, 80231
Sponsors and Collaborators
Kaiser Permanente
American Heart Association
Investigators
Principal Investigator: David J Magid, MD, MPH Kaiser Permanente
Principal Investigator: Kari Olson, PharmD Kaiser Permanente
Principal Investigator: Sarah J Billups, PharmD Kaiser Permanente
  More Information

No publications provided

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT01162759     History of Changes
Other Study ID Numbers: CO-08DMagi-01
Study First Received: July 13, 2010
Last Updated: April 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Kaiser Permanente:
hypertension, intervention

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 17, 2012