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

October 17, 2014 updated by: Ellen Chen, University of California, San Francisco
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

441

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94110
        • Mission Neighborhood Health Center
      • San Francisco, California, United States, 94124
        • Southeast Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite clinical outcome measure- improvement in either HgA1C, SBP, or LDL
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

October 11, 2010

First Submitted That Met QC Criteria

October 11, 2010

First Posted (Estimate)

October 13, 2010

Study Record Updates

Last Update Posted (Estimate)

October 21, 2014

Last Update Submitted That Met QC Criteria

October 17, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCSF CEPC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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