- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01162759
Home Blood Pressure Monitoring Project (HBPM)
April 4, 2012 updated by: Kaiser Permanente
Home Blood Pressure Monitoring Program
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
348
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Denver, Colorado, United States, 80231
- Kaiser Permanente Colorado, Institute of Health Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Usual Care
The control group receiving usual care
|
|
Experimental: Home Blood Pressure Monitoring Group
Intervention group
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
BP at 6 months
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Actual)
July 1, 2010
Study Completion (Actual)
July 1, 2010
Study Registration Dates
First Submitted
July 13, 2010
First Submitted That Met QC Criteria
July 13, 2010
First Posted (Estimate)
July 15, 2010
Study Record Updates
Last Update Posted (Estimate)
April 6, 2012
Last Update Submitted That Met QC Criteria
April 4, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CO-08DMagi-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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