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NCT05169359Active, not recruiting

Empowering Veterans to Actively Communicate and Engage in Shared Decision Making in Medical Visits, A Randomized Controlled Trial

Source: ClinicalTrials.gov · Last updated 20 Jul 2025

Brief summary (registry, in English)

Type 2 diabetes is a significant condition in VA affecting 20% of VA patients. Adherence to medication regimens and lifestyle factors is important to achieve care goals for these patients. Patients who use active participatory communication behaviors with their providers have better adherence to treatment and better biomedical outcomes, yet many patients are not prepared to engage in active communication with their providers. Existing coaching interventions have not been adopted in practice because of the cost of trained personnel. The investigators have shown the efficacy of a low-cost video that did not require trained personnel. This proposal proposes to test implementation strategies to deliver that video in VA primary care clinics and to test the effectiveness of the video to improve outcomes in a Hybrid Type 2 effectiveness-implementation trial using a cluster randomized stepped wedge design at eight sites. This proposal will test feasibility of implementing the video and if successful will generate the evidence to justify widespread dissemination of the video.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
512 (actual)
First submitted
2 Dec 2021
Start date
1 Oct 2022
Primary completion date
30 Jun 2025
Lead sponsor
VA Office of Research and Development
NCT number
NCT05169359

What you commit to

  • Study type: Interventional
  • Participants enrolled: 512
  • From 1 Oct 2022 to the primary completion date, 30 Jun 2025
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Dementia (abnormal SBT)63
  • Terminal medical condition
  • Drug- (e.g., steroid) induced diabetes.

Lab values

  • Creatinine \>3 (or eGFR\<20), recent MI or admission for HF

Other

  • Lives in skilled nursing facility
  • Blind or deaf (e.g., unable to view/hear video

Who the study is looking for

  • Dx of T2D
  • Hemoglobin A1c ("A1c") 7 or greater
  • Adults, age 18 or older
  • Visit at a participating site
  • Receives care from primary care provider more than once a year at VA

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Jesse Brown VA Medical Center, Chicago, IL
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status
Adam Benjamin Jr VA Outpatient Clinic, Crown Point, IN
Coordinator of this site? Confirm its status
Crown PointUnited StatesUnknown status
Edward Hines Jr. VA Hospital, Hines, IL
Coordinator of this site? Confirm its status
HinesUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.