Treating to Target for Patients With Hypertension

This study has been completed.

Sponsor:

Collaborator:

Kaiser Permanente

Information provided by (Responsible Party):

Thomas Bodenheimer, University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT01013857

First received: November 12, 2009

Last updated: November 9, 2012

Last verified: November 2012

History of Changes

Purpose

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

Condition	Intervention
Hypertension	Behavioral: Health coaching Behavioral: Health coaching plus home titration


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Treating to Target for Patients With Hypertension

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

Systolic blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Diastolic blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]


Enrollment:	240
Study Start Date:	January 2009
Study Completion Date:	December 2011
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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).

Eligibility


Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
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.

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

No publications provided by University of California, San Francisco

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bennett H, Laird K, Margolius D, Ngo V, Thom DH, Bodenheimer T. The effectiveness of health coaching, home blood pressure monitoring, and home-titration in controlling hypertension among low-income patients: protocol for a randomized controlled trial. BMC Public Health. 2009 Dec 10;9:456. doi: 10.1186/1471-2458-9-456.


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
Study First Received:	November 12, 2009
Last Updated:	November 9, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:


Hypertension Cardiovascular Diseases Vascular Diseases

ClinicalTrials.gov processed this record on February 27, 2015

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