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Behavioural Intervention
Intensive Education for Managing Type 2 Diabetes and Cardiovascular Disease (COORDINATE Trial)
N/A
Waitlist Available
Led By Christopher Granger, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of Type 2 diabetes mellitus (T2DM)
History of at least one of the following conditions: Coronary artery disease (defined as prior MI, coronary revascularization (CABG or PCI), and/or obstructive CAD (≥50%) as documented by angiography or CTA)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
COORDINATE Trial Summary
This trial is testing an educational intervention to see if it can improve the management of type 2 diabetes and cardiovascular disease.
Who is the study for?
Adults over 18 with Type 2 Diabetes and a history of cardiovascular disease, such as heart attacks, strokes, or poor circulation in limbs. They must be able to understand the study and give consent. People can't join if they have severe kidney issues (GFR<30), are on all recommended treatments for their conditions, or aren't expected to survive/follow-up for at least a year.Check my eligibility
What is being tested?
The trial is testing an intense educational program designed to improve treatment management for patients with Type 2 Diabetes who also have cardiovascular disease. Clinics are randomly chosen to either use this new education approach or continue usual care.See study design
What are the potential side effects?
Since this is an educational intervention rather than a drug treatment, there may not be direct side effects like those seen with medication. However, changes in diabetes management could lead to low blood sugar levels or other adjustments.
COORDINATE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Type 2 diabetes.
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I have a history of heart disease, including a heart attack, surgery to improve blood flow to the heart, or blocked arteries.
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I have poor circulation in my legs, confirmed by tests or past surgeries.
Select...
I am 18 years old or older.
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I have had heart disease, stroke, or poor blood flow in my legs.
Select...
I have been diagnosed with Type 2 diabetes.
Select...
I am 18 years old or older.
Select...
I am 18 years old or older.
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I have had a stroke or my carotid artery is more than half blocked.
COORDINATE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Implementing a clinic-level multifaceted intervention
Secondary outcome measures
Changes in blood pressure control at last follow-up visit.
Changes in cholesterol levels at last follow-up visit.
Changes in glycemic control at last follow-up visit.
+2 moreCOORDINATE Trial Design
2Treatment groups
Active Control
Group I: InterventionActive Control1 Intervention
The cardiology clinics in the intensive educational intervention arm will receive guidance to develop an integrated, multi-disciplinary care pathway for patients with T2DM and CVD.
Group II: ControlActive Control1 Intervention
Clinics in the control arm will be encouraged to follow guideline-based care.
Who is running the clinical trial?
Eli Lilly and CompanyIndustry Sponsor
2,605 Previous Clinical Trials
3,198,621 Total Patients Enrolled
Boehringer IngelheimIndustry Sponsor
2,494 Previous Clinical Trials
10,915,823 Total Patients Enrolled
Duke UniversityLead Sponsor
2,351 Previous Clinical Trials
3,408,497 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with Type 2 diabetes.I have a history of heart disease, including a heart attack, surgery to improve blood flow to the heart, or blocked arteries.I have poor circulation in my legs, confirmed by tests or past surgeries.I am 18 years old or older.I have had heart disease, stroke, or poor blood flow in my legs.I am currently on all recommended treatments for type 2 diabetes and heart disease.I have been diagnosed with Type 2 diabetes.I am 18 years old or older.My kidney function is low (GFR under 30).I cannot take standard treatments for type 2 diabetes and heart disease.I am 18 years old or older.I have had a stroke or my carotid artery is more than half blocked.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
- Group 2: Control
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.
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT03936660 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the number of sites managing this investigation?
"Patients can be enrolled in this medical trial at 32 locations, including but not limited to Black Hills Cardiovascular Research (Rapid City), Bayfront Cardiovascular Associates (Saint Petersburg) and Emory/Grady Memorial Hospital (Atlanta)."
Answered by AI
Are there still opportunities for participants to join this trial?
"According to the details on clinicaltrials.gov, recruitment for this particular trial has been concluded as of September 22nd 2022. Although no longer actively enrolling patients, 1768 other medical studies are currently recruiting individuals in need of treatment."
Answered by AI
Who else is applying?
What state do they live in?
Illinois
Texas
Arizona
Other
How old are they?
65+
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
USA Cardiology
Orlando Heart and Vascular Institute
Dignity Health/DHMG Specialty Medicine
Other
How many prior treatments have patients received?
2
0
Why did patients apply to this trial?
Hi! My name is Curtis Robinson curtisrobinson212@gmail.com 469-478-0609. I want to improve my life and have less medical problems moving forward with Diab II!
PatientReceived no prior treatments
i want to contribute to this clinical trial to make a difference and help myself and others.
PatientReceived no prior treatments
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