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

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

Tracking Information

• First Submitted Date: October 11, 2010
• First Posted Date: October 13, 2010
• Last Update Posted Date: October 21, 2014
• Study Start Date: April 2011
• Actual Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 11, 2010): Composite clinical outcome measure- improvement in either HgA1C, SBP, or LDL [ Time Frame: 12 months ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 5, 2013)

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.

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study of Medical Assistant Health Coaching in Primary Care for Patients With Chronic Conditions
• Official Title: Not Provided
• 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
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor)

Condition

• Diabetes
• Hypertension
• Hyperlipidemia

Intervention

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.

Study Arms

Experimental: Health Coaching

Intervention: Behavioral: Health coaching by medical assistants in primary care

• Publications *: Willard-Grace R, DeVore D, Chen EH, Hessler D, Bodenheimer T, Thom DH. The effectiveness of medical assistant health coaching for low-income patients with uncontrolled diabetes, hypertension, and hyperlipidemia: protocol for a randomized controlled trial and baseline characteristics of the study population. BMC Fam Pract. 2013 Feb 23;14:27. doi: 10.1186/1471-2296-14-27.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 17, 2014): 441
• Original Estimated Enrollment (submitted: October 11, 2010): 440
• Actual Study Completion Date: June 2014
• Actual Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01220336
• Other Study ID Numbers: UCSF CEPC
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Ellen Chen, University of California, San Francisco
• Original Responsible Party: Ellen Chen, MD, UCSF Department of Family and Community Medicine
• Current Study Sponsor: University of California, San Francisco
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Ellen Chen, MD; University of California, San Francisco
• Principal Investigator: David Thom, MD, PhD; University of California, San Francisco

• PRS Account: University of California, San Francisco
• Verification Date: October 2014