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Study of Medical Assistant Health Coaching in Primary Care for Patients With Chronic Conditions (HCPC)

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: NCT01220336
Recruitment Status : Completed
First Posted : October 13, 2010
Last Update Posted : October 21, 2014
Sponsor:
Information provided by (Responsible Party):
Ellen Chen, University of California, San Francisco

Study Description
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Brief Summary:
Randomized control trial studying the effect of medical assistant health coaching for patients with diabetes, hypertension and hyperlipidemia within two San Francisco primary care community clinics, Mission Neighborhood Health Center and Southeast Health Center

Condition or disease Intervention/treatment Phase
Diabetes Hypertension Hyperlipidemia Behavioral: Health coaching by medical assistants in primary care Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 441 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Study Start Date : April 2011
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Health Coaching Behavioral: Health coaching by medical assistants in primary care
Patients with uncontrolled diabetes, hypertension, hyperlipidemia will receive health coaching by medical assistants working with primary care providers in the Teamlet Model [Bodenheimer 2007] for 12 months.


Outcome Measures
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Primary Outcome Measures :
  1. Composite clinical outcome measure- improvement in either HgA1C, SBP, or LDL [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Composite clinical outcome measure- improvement in either HgA1C, SBP, or LDL [ Time Frame: 24 months ]
    This second measurement of clinical outcomes will occurs one year after the end of the intervention.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Active patients at Mission Neighborhood Health Center, SF, USA or Southeast Health Center, SF, USA age 18-75 years Uncontrolled diabetes II, hypertension or hyperlipidemia Spanish or English speaking

Exclusion Criteria:

Cognitive dysfunction, mental health or physical condition that prevents participation in health coaching.

Contacts and Locations
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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): NCT01220336


Locations
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United States, California
Mission Neighborhood Health Center
San Francisco, California, United States, 94110
Southeast Health Center
San Francisco, California, United States, 94124
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Ellen Chen, MD University of California, San Francisco
Principal Investigator: David Thom, MD, PhD University of California, San Francisco
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ellen Chen, Adjunct Faculty, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01220336    
Other Study ID Numbers: UCSF CEPC
First Posted: October 13, 2010    Key Record Dates
Last Update Posted: October 21, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases