← Back to Search

Speak Up! Video for Diabetes (ACTIVet-2 Trial)

N/A
Recruiting
Led By Howard S. Gordon, MD BS
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults, age 18 or older
Diagnosis of T2D
Timeline
Screening 3 weeks
Treatment Varies
Follow Up collected at baseline and 3 months post-visit
Awards & highlights

ACTIVet-2 Trial Summary

This trial will test the effectiveness of a low-cost video in improving outcomes for VA patients with type 2 diabetes. The video does not require trained personnel, and the trial will test feasibility of implementing the video in VA primary care clinics.

Who is the study for?
This trial is for adult veterans with Type 2 diabetes who have an A1c level of 7 or higher and are receiving care at a participating site. It's not suitable for those with terminal conditions, severe kidney issues, recent heart problems, dementia, living in nursing facilities, or who are blind/deaf.Check my eligibility
What is being tested?
The trial is testing the 'Speak Up! Video' as a tool to help diabetic patients communicate better with their healthcare providers. The study will evaluate if this video can improve medication adherence and health outcomes without needing trained personnel.See study design
What are the potential side effects?
Since the intervention involves educational material rather than medical treatment, there are no direct side effects like you'd expect from drugs. However, participants may experience discomfort or anxiety related to discussing their condition more openly.

ACTIVet-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I have been diagnosed with type 2 diabetes.

ACTIVet-2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~collected at baseline and 3 months post-visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and collected at baseline and 3 months post-visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline HgbA1c at 3 months post-visit
Change from pre-visit communication self-efficacy score at 1 week post visit
Change from pre-visit diabetes distress score at 1 week post visit
Secondary outcome measures
Change from baseline functional status score at 1 week post visit
Change from baseline trust in provider score at 1 week post visit
Change from pre-visit medication adherence at 1 week post visit
+8 more

ACTIVet-2 Trial Design

1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
The study is a type 2 hybrid Effectiveness Implementation trial. The study uses a stepped wedge design. Patients are in a usual care phase until their clinic begins active implementation. Once active implementation begins, patients will view the Speak Up! Video intervention prior to their visit. The 10-minute video program will be provided to patients for viewing on an iPad (or other modality such as a portable DVD player, computer, or TV as appropriate to the site based on PDSA activities during implementation planning).

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,618 Previous Clinical Trials
3,315,663 Total Patients Enrolled
23 Trials studying Diabetes
13,610 Patients Enrolled for Diabetes
Howard S. Gordon, MD BSPrincipal InvestigatorJesse Brown VA Medical Center, Chicago, IL
1 Previous Clinical Trials
102 Total Patients Enrolled

Media Library

Speak Up! Video Clinical Trial Eligibility Overview. Trial Name: NCT05169359 — N/A
Diabetes Clinical Trial 2023: Speak Up! Video Highlights & Side Effects. Trial Name: NCT05169359 — N/A
Speak Up! Video 2023 Treatment Timeline for Medical Study. Trial Name: NCT05169359 — N/A
Diabetes Research Study Groups: Intervention
Diabetes Patient Testimony for trial: Trial Name: NCT05169359 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

With what objectives is this experiment hoping to accomplish?

"The primary outcome of this clinical trial, evaluated at baseline and 3 months post-visit, is to observe any variance from the pre-visit diabetes distress score a week after the visit. Additionally, secondary outcomes are (1) Patient Centered Care assessed using the Consultation Care Measure; ranging 21 - 105 with higher scores indicating better patient ratings of their provider; (2) Change in medication adherence measured through VA pharmacy data over a three month period via mean Medication Possession Ratio; and (3) Evaluation of patient engagement utilizing Altarum Consumer Engagement measure across 8 items on two subscales between 8 - 40 points where"

Answered by AI

What is the current enrollment size of this research endeavor?

"Affirmative. Clinicaltrials.gov states that this medical trial is currently in the recruitment phase, which began on October 1st and was last modified on October 14th. A total of 510 people need to be recruited across two distinct locations."

Answered by AI

Is enrollment still open for this clinical experimentation?

"According to clinicaltrials.gov, this study is actively recruiting patients. This trial was first shared on October 1st 2022 and has recently been modified as of the 14th of October 2022."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
What site did they apply to?
Jesse Brown VA Medical Center, Chicago, IL
Aurora CBOC
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I WOULD LIKE TO LIVE LONGER !
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Empowering Veterans to Actively Communicate and Engage in Shared Decision Making in Medical Visits, A Randomized Controlled Trial
2022. "Empowering Veterans to Actively Communicate and Engage in Shared Decision Making in Medical Visits, A Randomized Controlled Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05169359.
~207 spots leftby Jun 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top