ClinicalTrials.gov
ClinicalTrials.gov Menu

Treating to Target for Patients With Hypertension

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: NCT01013857
Recruitment Status : Completed
First Posted : November 16, 2009
Last Update Posted : November 14, 2012
Sponsor:
Collaborator:
Kaiser Permanente
Information provided by (Responsible Party):
Thomas Bodenheimer, University of California, San Francisco

Brief Summary:
Patients with poorly controlled hypertension will have improved hypertensive control with telephone coaching and with telephone coaching combined with home-titration of medications.

Condition or disease Intervention/treatment Phase
Hypertension Behavioral: Health coaching Behavioral: Health coaching plus home titration Not Applicable

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  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treating to Target for Patients With Hypertension
Study Start Date : January 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : December 2011

Arm Intervention/treatment
Active Comparator: Health coaching
Phone patients every week to discuss medication adherence
Behavioral: Health coaching
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
Behavioral: Health coaching plus home titration
Calling patients every week and intensifying medications if appropriate based on physician-created algorithm




Primary Outcome Measures :
  1. Systolic blood pressure [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Diastolic blood pressure [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01013857


Locations
United States, California
San Francisco General Hospital
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
Kaiser Permanente
Investigators
Principal Investigator: Thomas Bodenheimer, MD University of California, San Francisco

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas Bodenheimer, Adjunct Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01013857     History of Changes
Other Study ID Numbers: H40013-33128-02
First Posted: November 16, 2009    Key Record Dates
Last Update Posted: November 14, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases