- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01013857
Treating to Target for Patients With Hypertension
March 7, 2022 updated by: University of California, San Francisco
Patients with poorly controlled hypertension will have improved hypertensive control with telephone coaching and with telephone coaching combined with home-titration of medications.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patients with poorly controlled hypertension are randomized to a control arm which receives telephone coaching or an active arm which receives telephone coaching plus intensification of medications via telephone coaching with the coaches using treatment algorithms approved by the patients' physician.
These patients' blood pressure control will be compared with usual care patients in a passive arm (chart review only).
Study Type
Interventional
Enrollment (Actual)
240
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
-
-
California
-
San Francisco, California, United States, 94110
- San Francisco General Hospital
-
-
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
30 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 2 blood pressure readings above 145/90.
Exclusion Criteria:
- Cognitive impairment,
- Short life expectancy,
- Creatinine greater than 1.5,
- Inability to check blood pressures at home.
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 |
---|---|
Active Comparator: Health coaching
Phone patients every week to discuss medication adherence
|
Calling patients every week to discuss medication adherence
|
Experimental: Health coaching plus home-titration
Health coaches call patients every week to discuss medication adherence and to intensify medications if appropriate according to physician-created algorithm
|
Calling patients every week and intensifying medications if appropriate based on physician-created algorithm
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Systolic blood pressure
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Diastolic blood pressure
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Thomas Bodenheimer, MD, University of California, San Francisco
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
January 1, 2009
Primary Completion (Actual)
February 1, 2010
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
November 12, 2009
First Submitted That Met QC Criteria
November 13, 2009
First Posted (Estimate)
November 16, 2009
Study Record Updates
Last Update Posted (Actual)
March 21, 2022
Last Update Submitted That Met QC Criteria
March 7, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H40013-33128-02
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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