Skip to main content
OpenTrials
Completed

NCT Number: NCT00668590

Improving Diabetes Care With Patient Decision Aids - A Trial in Community-based Primary Care

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:

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Community-based primary care practices, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Primary language other than English.
  • Severe visual impairment
  • Currently enrolled in a diabetes education or support program, or participated in a diabetes education or support program in the last 6 months.

Treatment and study plan

Patient video decision aid & telephone coaching

Behavioral

The decision aid is a 30 minute video program that educates patients about their role in diabetes care. Telephone coaching will assist patients in initiating behavior change.

Printed educational brochure

Behavioral

The printed brochure is an educational brochure developed by the NIH.

Primary outcomes

  1. Hemoglobin A1c

    Time frame: 6 months

Secondary outcomes

  1. Diabetes self-care behaviors

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Foundation for Informed Medical Decision Making
  • Robert Wood Johnson Foundation

Registry information

Official study title

Improving Diabetes Care With Patient Decision Aids - A Randomized Controlled Trial in Community-based Primary Care

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Apr 29, 2008
Registry last updated
Apr 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.