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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ellen Chen, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01220336
First received: October 11, 2010
Last updated: July 5, 2013
Last verified: July 2013
  Purpose

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 Intervention
Diabetes
Hypertension
Hyperlipidemia
Behavioral: Health coaching by medical assistants in primary care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Composite clinical outcome measure- improvement in either HgA1C, SBP, or LDL [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Composite clinical outcome measure- improvement in either HgA1C, SBP, or LDL [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    This second measurement of clinical outcomes will occurs one year after the end of the intervention.


Estimated Enrollment: 440
Study Start Date: April 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01220336

Locations
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
Principal Investigator: Ellen Chen, MD University of California, San Francisco
Principal Investigator: David Thom, MD, PhD 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: Ellen Chen, Adjunct Faculty, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01220336     History of Changes
Other Study ID Numbers: UCSF CEPC
Study First Received: October 11, 2010
Last Updated: July 5, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hyperlipidemias
Hypertension
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 14, 2014