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Decision Support Strategies for Cardiovascular Risk Management (T3 Trial)
N/A
Recruiting
Led By Muthiah Vadduganathan, MD
Research Sponsored by American College of Cardiology
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 study duration up to 1 year.
Awards & highlights
T3 Trial Summary
This trial helps improve use of treatments that lower CV risks for heart failure, AFib, T2D/ASCVD, especially in underserved populations.
Who is the study for?
Adults with personal tech access, diagnosed with heart failure, atrial fibrillation (with certain risk scores), or type 2 diabetes with cardiovascular disease. Not for those in other drug/device trials, pregnant/breastfeeding women, life expectancy under a year, without recent clinical visits, on comfort care/hospice or specific heart conditions.Check my eligibility
What is being tested?
The trial tests if technology-based decision support and virtual team referrals can improve the use of recommended treatments to lower cardiovascular events in patients with heart failure, atrial fibrillation and type 2 diabetes—focusing on underserved groups.See study design
What are the potential side effects?
Since this is not a drug trial but an initiative using decision support tools and educational resources to manage existing conditions better, traditional medication side effects are not applicable. However, there may be indirect effects related to changes in treatment plans.
T3 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ study duration up to 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study duration up to 1 year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Atrial Fibrillation
Secondary outcome measures
Quality of Life Outcome-KCCQ-12
Quality of Life Outcome-MMA-4
Quality of Life Outcome-PAM
T3 Trial Design
3Treatment groups
Active Control
Group I: Usual CareActive Control1 Intervention
Teaching - CardioSmart Resources + Clinician Education
Group II: Decision SupportActive Control1 Intervention
Technology - Facilitated Solution (Existing Team)
Group III: ReferralActive Control1 Intervention
Teams - Protocol-Supported Team, (Virtual GDMT Team)
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Who is running the clinical trial?
American College of CardiologyLead Sponsor
17 Previous Clinical Trials
325,236 Total Patients Enrolled
4 Trials studying Heart Failure
1,926 Patients Enrolled for Heart Failure
Muthiah Vadduganathan, MDPrincipal InvestigatorMass General Brigham
Megan Welch, MDPrincipal InvestigatorMassachusetts General Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently in or plan to join another type of experimental medical study, except for the TRANSFORM3 GDMT trial.You haven't seen a doctor in the last three years before the study starts.You are currently receiving end-of-life care or enrolled in hospice.Criterion: You have atrial fibrillation and are currently taking a certain blood thinner medication, have certain reversible causes of atrial fibrillation, have had a recent stroke or mini-stroke, have low platelet count or hemoglobin levels, have a history of bleeding disorders, have had recent major surgery or trauma, or have had significant gastrointestinal bleeding within a certain time frame.You have heart failure, atrial fibrillation with a specific score, type 2 diabetes with cardiovascular disease, or other related conditions like coronary artery disease, stroke, or peripheral artery disease.You are not expected to live for more than one year.You have a history of or plan for a heart transplant or have a certain type of advanced heart failure.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care
- Group 2: Decision Support
- Group 3: Referral
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
How many participants are being enrolled in this experiment?
"Affirmative. The information available on clinicaltrials.gov suggests that this medical investigation is actively recruiting participants, with the trial first posted to the website on September 30th 2022 and last updated October 5th 2022. This study requires a total of 750 patients from 1 location to take part in it's research endeavours."
Answered by AI
Are researchers currently enrolling volunteers for this clinical trial?
"Indeed, the data on clinicaltrials.gov verifies that this trial is actively seeking volunteers. It was initially posted on September 30th 2022 and last updated October 5th 2022. A total of 750 participants are needed to be recruited from 1 healthcare centre."
Answered by AI
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