Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Home Blood Pressure Monitoring Project (HBPM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01162759
Recruitment Status : Completed
First Posted : July 15, 2010
Last Update Posted : April 6, 2012
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Kaiser Permanente

Tracking Information
First Submitted Date  ICMJE July 13, 2010
First Posted Date  ICMJE July 15, 2010
Last Update Posted Date April 6, 2012
Study Start Date  ICMJE July 2008
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2010)
BP at 6 months [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Home Blood Pressure Monitoring Project
Official Title  ICMJE Home Blood Pressure Monitoring Program
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE 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
Study Arms  ICMJE
  • No Intervention: Usual Care
    The control group receiving usual care
  • Experimental: Home Blood Pressure Monitoring Group
    Intervention group
    Intervention: Behavioral: Home Blood Pressure Monitoring
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 13, 2010)
348
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01162759
Other Study ID Numbers  ICMJE CO-08DMagi-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kaiser Permanente
Study Sponsor  ICMJE Kaiser Permanente
Collaborators  ICMJE American Heart Association
Investigators  ICMJE
Principal Investigator: David J Magid, MD, MPH Kaiser Permanente
Principal Investigator: Kari Olson, PharmD Kaiser Permanente
Principal Investigator: Sarah J Billups, PharmD Kaiser Permanente
PRS Account Kaiser Permanente
Verification Date April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP