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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00668590
Enrollment
201
Registered
2008-04-29
Start date
2008-08-31
Completion date
2010-08-31
Last updated
2011-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Keywords

Diabetes

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: 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.

Interventions

BEHAVIORALPatient video decision aid & telephone coaching

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.

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

Sponsors

Robert Wood Johnson Foundation
CollaboratorOTHER
Foundation for Informed Medical Decision Making
CollaboratorOTHER
University of California, Los Angeles
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Hemoglobin A1c6 months

Secondary

MeasureTime frame
Diabetes self-care behaviors6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026