Study of Medical Assistant Health Coaching in Primary Care for Patients With Chronic Conditions (HCPC)
This study is ongoing, but not recruiting participants.
Sponsor:
University of California, San Francisco
Information provided by (Responsible Party):
Ellen Chen, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01220336
First received: October 11, 2010
Last updated: August 29, 2012
Last verified: August 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | October 11, 2010 | ||||||||
| Last Updated Date | August 29, 2012 | ||||||||
| Start Date ICMJE | April 2011 | ||||||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Composite clinical outcome measure- improvement in either HgA1C, SBP, or LDL [ Time Frame: 12 months ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01220336 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Study of Medical Assistant Health Coaching in Primary Care for Patients With Chronic Conditions | ||||||||
| Official Title ICMJE | Not Provided | ||||||||
| Brief Summary | Randomized control trial studying the effect of medical assistant health coaching for patients with diabetes, hypertension and hyperlipidemia within a primary care community clinic, Mission Neighborhood Health Center |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) |
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| Condition ICMJE |
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| Intervention ICMJE | 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. |
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| Study Arm (s) | Experimental: Health Coaching
Intervention: Behavioral: Health coaching by medical assistants in primary care |
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| 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. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||
| Estimated Enrollment ICMJE | 440 | ||||||||
| Estimated Completion Date | June 2013 | ||||||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | 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. |
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| Gender | Both | ||||||||
| Ages | 18 Years to 75 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01220336 | ||||||||
| Other Study ID Numbers ICMJE | UCSF CEPC | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Ellen Chen, University of California, San Francisco | ||||||||
| Study Sponsor ICMJE | University of California, San Francisco | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of California, San Francisco | ||||||||
| Verification Date | August 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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