Helping Veterans Communicate Better with Their Doctors About Diabetes
Empowering Veterans to Actively Communicate and Engage in Shared Decision Making in Medical Visits, A Randomized Controlled Trial
NA · VA Office of Research and Development · NCT05169359
This study is testing a video tool to help veterans with Type 2 diabetes communicate better with their doctors and make shared decisions about their care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 512 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development (fed) |
| Locations | 8 sites (Chicago Heights, Illinois and 7 other locations) |
| Trial ID | NCT05169359 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to improve communication between veterans with Type 2 diabetes and their healthcare providers by implementing a low-cost video intervention called Speak Up!. The study will be conducted in VA primary care clinics using a cluster randomized stepped wedge design across eight sites. By empowering patients to engage in shared decision-making, the trial seeks to enhance medication adherence and overall health outcomes for veterans suffering from diabetes. The effectiveness of the video will be evaluated alongside its feasibility for implementation in clinical practice.
Who should consider this trial
Good fit: Ideal candidates for this study are veterans aged 18 and older diagnosed with Type 2 diabetes and an A1c level of 7 or greater who receive regular care from a VA primary care provider.
Not a fit: Patients living in skilled nursing facilities, those with dementia, or individuals unable to view or hear the video will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could lead to better health outcomes and improved quality of life for veterans with Type 2 diabetes.
How similar studies have performed: Previous studies have shown success with similar video interventions in improving patient communication and health outcomes, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* Lives in skilled nursing facility
* Dementia (abnormal SBT)63
* Creatinine \>3 (or eGFR\<20), recent MI or admission for HF
* Terminal medical condition
* Drug- (e.g., steroid) induced diabetes.
* Blind or deaf (e.g., unable to view/hear video
Where this trial is running
Chicago Heights, Illinois and 7 other locations
- Chicago Heights VA Clinic — Chicago Heights, Illinois, United States (RECRUITING)
- Lakeside VA Clinic — Chicago, Illinois, United States (RECRUITING)
- Jesse Brown VA Medical Center, Chicago, IL — Chicago, Illinois, United States (RECRUITING)
- Edward Hines Jr. VA Hospital, Hines, IL — Hines, Illinois, United States (RECRUITING)
- Hoffman Estates VA Clinic — Hoffman Estates, Illinois, United States (RECRUITING)
- Joliet VA Clinic — Joliet, Illinois, United States (RECRUITING)
- Aurora VA Clinic — North Aurora, Illinois, United States (RECRUITING)
- Adam Benjamin Jr VA Outpatient Clinic, Crown Point, IN — Crown Point, Indiana, United States (RECRUITING)
Study contacts
- Principal investigator: Howard S. Gordon, MD BS — Jesse Brown VA Medical Center, Chicago, IL
- Study coordinator: Howard S Gordon, MD BS
- Email: howard.gordon2@va.gov
- Phone: (312) 569-7331
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetes Mellitus