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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: Active NA study of Diabetes Mellitus, Type 2, sponsored by VA Office of Research and Development.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
HgbA1c is regarded as the standard laboratory measurement (blood test) for assessing the control of diabetes over approximately three months preceding the test. HgbA1c is usually checked several times a year in patients with poorly controlled diabetes.
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
| Field | Value |
|---|---|
| Enrollment Target | 512 participants |
| Start Date | 2022-10-01 |
| Est. Completion | 2026-03-31 |
| Phase | NA |
What the registry record for NCT05169359 still lists
NCT05169359 is an interventional study that assigns participants to a tested intervention. The registered 512 participants enrollment target is mid-sized for trials with a published cap, below the 4,484-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (89% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus, Type 2
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05169359's enrollment target sits among peer trials
512 74th of 348 higher than 274 of 348 other Diabetes Mellitus, Type 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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