Improving Diabetes Care With Patient Decision Aids - A Trial in Community-based Primary Care
Tracking Information | |||||
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First Received Date ICMJE | April 25, 2008 | ||||
Last Updated Date | April 8, 2011 | ||||
Start Date ICMJE | August 2008 | ||||
Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Hemoglobin A1c [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00668590 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Diabetes self-care behaviors [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Improving Diabetes Care With Patient Decision Aids - A Trial in Community-based Primary Care | ||||
Official Title ICMJE | Improving Diabetes Care With Patient Decision Aids - A Randomized Controlled Trial in Community-based Primary Care | ||||
Brief Summary | Mounting evidence documents the positive impact of using patient decision aids (PtDA) to facilitate shared decision-making (SDM) between patients and physicians in preference sensitive contexts. But overall use of PtDAs across the broader US healthcare system remains low. More compelling evidence is needed to make the case for policies that would accelerate adoption of PtDAs in routine clinical practice in primary care settings that serve diverse and economically disadvantaged populations. The investigators believe that it is now time to move beyond the subjective evaluations of PtDAs that are commonly reported in clinical trials of PtDAs, to evaluate whether these tools can also change health behavior and improve health outcomes. Therefore, the investigators will build on their expertise in working with community-based physicians to evaluate a newly developed PtDA focused on diabetes, using a mixed-methods approach. The investigators patient sample will be drawn from primary care practices serving African American, Latino and Caucasian patients. The investigators will conduct a 2-group randomized controlled trial to evaluate the effects of the diabetes PtDA, combined with telephone coaching, in increasing patient self-care and self-efficacy, increasing diabetes knowledge and improving clinical measures including glycosylated hemoglobin A1c, lipids and blood pressure. The investigators will also explore variation in effects of the patient decision aid, comparing African American, Latino and Caucasian patients and conduct in-depth interviews with a randomly selected subset of trial participants to explore patient perceptions of the decision aid and variation across racial/ethnic groups. The investigators hypothesize that, compared to the control condition, participants assigned to receiving the video PtDA program and telephone coaching will report: greater self-efficacy and diabetes knowledge, more engagement in self-care behaviors, better glycemic control as measured by hemoglobin A1c, as well as lower quantitative LDL and blood pressure levels. The conceptual model guiding the investigators trial is the Integrative Model of Behavior Change. The model includes three primary determinants of behavior:
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Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | |||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Caregiver) |
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Condition ICMJE | Diabetes | ||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | Frosch DL, Uy V, Ochoa S, Mangione CM. Evaluation of a behavior support intervention for patients with poorly controlled diabetes. Arch Intern Med. 2011 Dec 12;171(22):2011-7. Epub 2011 Oct 10. | ||||
* 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 | Completed | ||||
Enrollment ICMJE | 201 | ||||
Completion Date | August 2010 | ||||
Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 40 Years and older | ||||
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 | NCT00668590 | ||||
Other Study ID Numbers ICMJE | G08-01-038-01 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Dominick L. Frosch, Ph.D., Assistant Professor, UCLA Department of Medicine | ||||
Study Sponsor ICMJE | University of California, Los Angeles | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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Information Provided By | University of California, Los Angeles | ||||
Verification Date | April 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |