NCT01220336

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
441

participants targeted

Target at P75+ for not_applicable diabetes

Timeline
Completed

Started Apr 2011

Typical duration for not_applicable diabetes

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 13, 2010

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

October 21, 2014

Status Verified

October 1, 2014

Enrollment Period

3.2 years

First QC Date

October 11, 2010

Last Update Submit

October 17, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Composite clinical outcome measure- improvement in either HgA1C, SBP, or LDL

    12 months

Secondary Outcomes (1)

  • Composite clinical outcome measure- improvement in either HgA1C, SBP, or LDL

    24 months

Study Arms (1)

Health Coaching

EXPERIMENTAL
Behavioral: Health coaching by medical assistants in primary care

Interventions

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.

Health Coaching

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mission Neighborhood Health Center

San Francisco, California, 94110, United States

Location

Southeast Health Center

San Francisco, California, 94124, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Diabetes MellitusHypertensionHyperlipidemias

Interventions

Primary Health Care

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesDyslipidemiasLipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Comprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Ellen Chen, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR
  • David Thom, MD, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Faculty

Study Record Dates

First Submitted

October 11, 2010

First Posted

October 13, 2010

Study Start

April 1, 2011

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

October 21, 2014

Record last verified: 2014-10

Locations