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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:

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
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):

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
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013