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NCT03936660 Clinical Trial

A 12 Month Site Randomized Trial in Adults With Type 2 Diabetes Mellitus and History of Cardiovascular Disease

Diabetes Mellitus, Type 2 Clinical Trial

— COORDINATE  

Official title:
COOrdinating CaRDIology CliNics RAndomized Trial of Interventions to Improve OutcomEs (COORDINATE) - Diabetes

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03936660
Other study ID # Pro00101556
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date July 25, 2019
Est. completion date June 30, 2027

Study information
Verified date January 2023
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

COORDINATE-Diabetes is a cluster-randomized clinical trial to test the effectiveness of an innovative, clinic-level educational intervention to improve the management of patients with type 2 diabetes mellitus and cardiovascular disease.

Description:

Patients with Type 2 diabetes mellitus and a history of cardiovascular disease will be enrolled in this study. The study will randomize a minimum of 42 US cardiology clinics to an intervention arm vs. control arm. The clinic-level multi-faceted educational intervention will include strategies to develop cardiology and endocrinology partnerships and guideline-recommended care pathways with measurement and feedback to improve the care of patients with type 2 diabetes mellitus and cardiovascular disease. Patients must be enrolled during a routine visit in a cardiology clinic, and the clinic must have at least 3 physicians and/or APPs on staff with independent patient populations.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 1049
Est. completion date June 30, 2027
Est. primary completion date December 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age = 18 years old - Diagnosis of Type 2 diabetes mellitus (T2DM) - History of at least one of the following conditions: 1. Coronary artery disease (defined as prior MI, coronary revascularization (CABG or PCI), and/or obstructive CAD (=50%) as documented by angiography or CTA) 2. Stroke and/or carotid artery stenosis (=50%) 3. Peripheral Arterial disease (defined as claudication with ABI<0.9, prior peripheral revascularization, and/or amputation due to circulatory insufficiency) - Ability to communicate with site staff and understand and provide written informed consent and proof of Health Insurance Portability and Accountability Act (HIPAA) authorization Exclusion Criteria: - Determined to be highly unlikely to survive and/or to continue follow-up in that clinic for at least 1 year, as identified by site investigator - GFR<30 mL/min/1.73m2 - Already on all guideline-recommended therapies for T2DM and CVD - Absolute contraindication to any of the guideline recommended therapies for T2DM and CVD

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Intense Education Intervention
Intervention will involve guideline-based care education.

Locations
Country Name City State
United States Endeavor Medical Research Alpena Michigan
United States Orlando Heart and Vascular Institute Altamonte Springs Florida
United States Alaska Heart and Vascular Institute Anchorage Alaska
United States Emory/Grady Memorial Hospital Atlanta Georgia
United States The Johns Hopkins University Baltimore Maryland
United States Grandview Health/Alabama Cardiovascular Group Birmingham Alabama
United States Riverside Medical Center/Synergy Healthcare Bradenton Florida
United States Bridgeport Hospital Bridgeport Connecticut
United States Advanced Heartcare LLC Bridgewater New Jersey
United States Kernodle Clinic Burlington North Carolina
United States Advocate Heart Institute Chicago Illinois
United States Lennar Foundation/Univ. of Miami Coral Gables Florida
United States Univ. of Texas Southwestern Dallas Texas
United States Aurora Denver Cardiology Denver Colorado
United States Iowa Heart Center Des Moines Iowa
United States Advanced Heart Care Group/Medicoricium LLC Fairview Heights Illinois
United States Cardiology Institute of Michigan Flint Michigan
United States Cone Health/LeBauer Brodie Ctr for Cardiovascular Rsch Greensboro North Carolina
United States Advanced Cardiology Associates Greenwood South Carolina
United States Hannibal Regional Medical Group Hannibal Missouri
United States Citrus Cardiology Inverness Florida
United States Baptist Health Research Institute Jacksonville Florida
United States New Jersey Heart Linden New Jersey
United States Garden State Heart Care Manalapan New Jersey
United States Northwell Health/Lenox Hill Hospital Manhasset New York
United States Heart Clinic of Louisiana Marrero Louisiana
United States USA Cardiology Mobile Alabama
United States Advanced Research for Health Improvement, LLC Naples Florida
United States Cardiovascular Health Clinic Oklahoma City Oklahoma
United States Specialty Physicians of Illinois Olympia Fields Illinois
United States Cardiovascular Inst. of Northwest Florida Panama City Florida
United States UnityPoint Health Cardiovascular Services Peoria Illinois
United States Dignity Health/DHMG Specialty Medicine Phoenix Arizona
United States Black Hills Cardiovascular Research Rapid City South Dakota
United States Bayfront Cardiovascular Associates Saint Petersburg Florida
United States Guthrie Medical Group Sayre Pennsylvania
United States Cardiovascular Associates of the Delaware Valley Sewell New Jersey
United States Prairie Cardiovascular Consultants Springfield Illinois
United States Stanford University Stanford California
United States Lonestar Heart and Vascular Tomball Texas
United States Interventional Cardiac Consultants Trinity Florida
United States Blue Coast Cardiology Vista California
United States ProHealth Care Heart and Vascular Waukesha Wisconsin
United States Cape Fear Heart Associates Wilmington North Carolina

Sponsors (3)
Lead Sponsor Collaborator
Duke University Boehringer Ingelheim, Eli Lilly and Company

Country where clinical trial is conducted

United States, 

References & Publications (6)

American Diabetes Association. 10. Cardiovascular Disease and Risk Management: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019 Jan;42(Suppl 1):S103-S123. doi: 10.2337/dc19-S010. — View Citation

American Diabetes Association. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019 Jan;42(Suppl 1):S90-S102. doi: 10.2337/dc19-S009. — View Citation

Marso SP, Daniels GH, Brown-Frandsen K, Kristensen P, Mann JF, Nauck MA, Nissen SE, Pocock S, Poulter NR, Ravn LS, Steinberg WM, Stockner M, Zinman B, Bergenstal RM, Buse JB; LEADER Steering Committee; LEADER Trial Investigators. Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2016 Jul 28;375(4):311-22. doi: 10.1056/NEJMoa1603827. Epub 2016 Jun 13. — View Citation

Sattar N, Petrie MC, Zinman B, Januzzi JL Jr. Novel Diabetes Drugs and the Cardiovascular Specialist. J Am Coll Cardiol. 2017 May 30;69(21):2646-2656. doi: 10.1016/j.jacc.2017.04.014. — View Citation

Vinereanu D, Lopes RD, Bahit MC, Xavier D, Jiang J, Al-Khalidi HR, He W, Xian Y, Ciobanu AO, Kamath DY, Fox KA, Rao MP, Pokorney SD, Berwanger O, Tajer C, de Barros E Silva PGM, Roettig ML, Huo Y, Granger CB; IMPACT-AF investigators. A multifaceted intervention to improve treatment with oral anticoagulants in atrial fibrillation (IMPACT-AF): an international, cluster-randomised trial. Lancet. 2017 Oct 14;390(10104):1737-1746. doi: 10.1016/S0140-6736(17)32165-7. Epub 2017 Aug 28. — View Citation

Zinman B, Lachin JM, Inzucchi SE. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2016 Mar 17;374(11):1094. doi: 10.1056/NEJMc1600827. No abstract available. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Implementing a clinic-level multifaceted intervention Proportion of patients achieving guideline-recommended management for T2DM and CVD at last follow-up visit. Up to 12 Months
Secondary Proportion of patients on guideline recommended therapies at last follow-up visit. Up to 12 Months
Secondary Changes in cholesterol levels at last follow-up visit. Baseline and last follow-up visit (up to 12 months)
Secondary Changes in blood pressure control at last follow-up visit. Baseline and last follow-up visit (up to 12 months)
Secondary Changes in glycemic control at last follow-up visit. Baseline and last follow-up visit (up to 12 months)
Secondary Measurement of average time from baseline to patient event. Up to 12 Months
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