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Improving Diabetes Care With Patient Decision Aids - A Randomized Controlled Trial in Community-Based Primary Care
This study is currently recruiting participants.
Verified by University of California, Los Angeles, December 2008
Sponsors and Collaborators: University of California, Los Angeles
Robert Wood Johnson Foundation
Foundation for Informed Medical Decision Making
Information provided by: University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00668590
  Purpose

Many clinical problems have multiple treatment options, with no clear "best" approach. Individual patient values are critical in making these "preference sensitive" medical decisions. In diabetes care there are typically also multiple options to choose from in pursuing the goals of better glycemic, lipid, and hypertension control. A shared or collaborative approach to clinical decision-making increases the likelihood that suggested changes are personally meaningful to a patient and can be translated into a "workable routine of daily disease management".

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 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 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 our trial is the Integrative Model of Behavior Change. The model includes three primary determinants of behavior:

  1. attitudes toward performing the behavior
  2. perceived social norms about performing the behavior
  3. self-efficacy. The investigators expect the diabetes PtDA to affect each of these constructs directly or indirectly.

Condition Intervention
Diabetes
Behavioral: Patient video decision aid
Behavioral: Printed educational brochure

MedlinePlus related topics: Diabetes
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Single Blind (Caregiver), Active Control, Parallel Assignment, Efficacy Study
Official Title: Improving Diabetes Care With Patient Decision Aids - A Randomized Controlled Trial in Community-Based Primary Care

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Hemoglobin A1c [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Diabetes self-care behaviors [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: August 2008
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Behavioral: Patient video decision aid
The decision aid is a 30 minute video program that educates patients about their role in diabetes care
2: Active Comparator Behavioral: Printed educational brochure
The printed brochure is an educational brochure developed by the NIH.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. At least 40 years old.
  2. Diagnosed with Type 2 diabetes at least 1 year ago.
  3. Attending the clinic for a routine diabetes follow-up visit.
  4. Completed at least 2 clinic visits in the past 12 months.
  5. Glycosylated hemoglobin A1c equal or greater than 8.0%
  6. Owns a DVD player and television at home
  7. Willing to provide informed consent.

Exclusion Criteria:

  1. Primary language other than English.
  2. Severe visual impairment
  3. Currently enrolled in a diabetes education or support program, or participated in a diabetes education or support program in the last 6 months.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00668590

Contacts
Contact: Visith Uy, BS visith@gmail.com

Locations
United States, California
UCLA Internal Medicine practices Recruiting
Los Angeles, California, United States, 90024
Community-based primary care practices Recruiting
Los Angeles, California, United States
Sponsors and Collaborators
University of California, Los Angeles
Robert Wood Johnson Foundation
Foundation for Informed Medical Decision Making
Investigators
Principal Investigator: Dominick L Frosch, Ph.D. University of California, Los Angeles
  More Information

Responsible Party: UCLA Department of Medicine ( Dominick L. Frosch, Ph.D., Assistant Professor )
Study ID Numbers: G08-01-038-01
Study First Received: April 25, 2008
Last Updated: December 3, 2008
ClinicalTrials.gov Identifier: NCT00668590  
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Diabetes

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009