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NCT05169359 · ClinicalTrials.gov registry record · NA

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

A NA study of Diabetes Mellitus, Type 2, sponsored by VA Office of Research and Development.

Active
Registry status
NA
Development phase
512
Enrollment target
3
Study locations

NCT05169359 is a NA study of Diabetes Mellitus, Type 2 that is active but no longer recruiting, run by VA Office of Research and Development. The registered enrollment target is 512 participants, below the 4,484-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (89% lower). The trial reports 3 study locations across 2 states.

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The verdict

NCT05169359, a NA study of Diabetes Mellitus, Type 2, is active but no longer recruiting, sponsored by VA Office of Research and Development.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
512 participants
Enrollment target
3
Study locations

Study Summary

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.

Conditions Studied

Interventions

  • BEHAVIORAL Speak Up! Video

Study Locations (3)

Illinois

  • Jesse Brown VA Medical Center, Chicago, IL - Chicago
  • Edward Hines Jr. VA Hospital, Hines, IL - Hines

Indiana

  • Adam Benjamin Jr VA Outpatient Clinic, Crown Point, IN - Crown Point

Trial Details

FieldValue
Enrollment Target 512 participants
Start Date 2022-10-01
Est. Completion 2026-03-31
Phase NA

Sponsor

VA Office of Research and Development

1,668 total trials

What the Registry Record Tells You About NCT05169359

The ClinicalTrials.gov registry entry for NCT05169359 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 512 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,484-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (89% lower). The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 1 intervention - of which Speak Up! Video is the first listed.

NCT05169359 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Illinois, Indiana.

Frequently Asked Questions

What is clinical trial NCT05169359 about?

NCT05169359 is a clinical study titled "Empowering Veterans to Actively Communicate and Engage in Shared Decision Making in Medical Visits, A Randomized Controlled Trial". 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 tre...

What is the current status of trial NCT05169359?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 512 participants. The study started on 2022-10-01. Estimated completion is 2026-03-31.

What conditions does trial NCT05169359 study?

This clinical trial studies the following conditions: Diabetes Mellitus, Type 2.

What interventions are being tested in trial NCT05169359?

The interventions under investigation include: Speak Up! Video (BEHAVIORAL).

Who is sponsoring clinical trial NCT05169359?

This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05169359 being conducted?

This trial has 3 study locations across Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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