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Open Access Audio for High Blood Pressure (OAA Trial)
N/A
Recruiting
Led By Saul J. Weiner, MD
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4-6 months
Awards & highlights
OAA Trial Summary
This trial will test whether audio recordings of medical visits help patients understand and manage their care, leading to better outcomes like lower blood pressure and diabetes control.
Who is the study for?
This trial is for patients with high blood pressure or diabetes who have appointments at the Jesse Brown VA Medical Center and Louis Stokes Cleveland VA Medical Center. There are no specific exclusion criteria, so all such patients can participate.Check my eligibility
What is being tested?
The study tests if having easy access to audio recordings of doctor visits helps patients better understand and manage their care. It compares outcomes like blood pressure control and hospital visits between those with open access to these recordings versus those without.See study design
What are the potential side effects?
Since this trial involves non-invasive technology (audio recordings) rather than medication, traditional side effects are not a concern. However, privacy issues or anxiety from listening to the recordings could potentially be considered 'side effects.'
OAA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4-6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4-6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Blood pressure
Contextualization of Care
Glycosylated Hemoglobin (HgB A1c)
+4 moreSecondary outcome measures
Emergency department utilization
hospital admission rate
OAA Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: OAA InterventionExperimental Treatment1 Intervention
Visit recorded, both patient and provider aware, both patient and provider have access to audio post-visit
Group II: OAA Physician Aware ControlPlacebo Group1 Intervention
Visit recorded, both patient and provider aware, neither patient nor provider have access to audio post-visit
Group III: OAA Physician Unaware ControlPlacebo Group1 Intervention
Visit recorded, patient aware but provider unaware, neither patient nor provider have access to audio post-visit
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,304,144 Total Patients Enrolled
22 Trials studying Diabetes
11,302 Patients Enrolled for Diabetes
Saul J. Weiner, MDPrincipal InvestigatorJesse Brown VA Medical Center, Chicago, IL
1 Previous Clinical Trials
138 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Patients with appointments at Jesse Brown VA Medical Center and the Louis Stokes Cleveland VA Medical Center are included.N/A
Awards:
This trial has 0 awards, including:Research Study Groups:
This trial has the following groups:- Group 1: OAA Physician Aware Control
- Group 2: OAA Physician Unaware Control
- Group 3: OAA Intervention
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities for participation in this endeavor?
"According to information found on clinicaltrials.gov, this study is actively seeking participants; it was first advertised on October 5th 2021 and updated most recently on October 7th 2022."
Answered by AI
What is the upper limit to the number of people currently enrolled in this research program?
"Affirmative. The details on clinicaltrials.gov suggest that this medical research is currently seeking participants; it was first posted on October 5th 2021 and subsequently amended on October 7th 2022. As such, 2308 patients need to be recruited between 2 distinct centres."
Answered by AI
Who else is applying?
What site did they apply to?
Jesse Brown VA Medical Center, Chicago, IL
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
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