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NCT01220336 Clinical Trial

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

Hypertension Clinical Trial

— HCPC  

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01220336
Other study ID # UCSF CEPC
Secondary ID
Status Completed
Phase N/A
First received October 11, 2010
Last updated October 17, 2014
Start date April 2011
Est. completion date June 2014

Study information
Verified date October 2014
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 441
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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.

Study Design

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

Related Conditions & MeSH terms

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.

Locations
Country Name City State
United States Mission Neighborhood Health Center San Francisco California
United States Southeast Health Center San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Composite clinical outcome measure- improvement in either HgA1C, SBP, or LDL 12 months No
Secondary Composite clinical outcome measure- improvement in either HgA1C, SBP, or LDL This second measurement of clinical outcomes will occurs one year after the end of the intervention. 24 months No
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