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

Not Applicable

Completed

• Conditions: Cardiovascular Diseases; Diabetes Mellitus, Type 2
• Interventions: Other: Intense Education Intervention

• Registration Number: NCT03936660
• Lead Sponsor: Duke University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-05-01
• Study First Submitted QC: 2019-05-01
• Study First Posted: 2019-05-03
• Study Start: 2019-07-25
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30
• Results First Submitted: 2023-06-07
• Status Verified: 2024-04
• Results First Submitted QC: 2024-11-15
• Last Update Submitted: 2024-11-15
• Results First Posted: 2024-11-21
• Last Update Posted: 2024-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1049

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Intense Education 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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Prescribed All 3 Groups of Recommended Evidence-based Medications	Up to 12 Months	Proportion of patients prescribed all three groups of guideline-recommended therapies for management for T2DM and CVD at last follow-up visit. Groups were defined as (1) high-intensity statins (40-80 mg/d atorvastatin or 20-40 mg/d rosuvastatin); (2) ACEIs or ARBs including angiotensin receptor-neprilysin inhibitors (ARNIs); and (3) SGLT2 inhibitors and/or GLP-1RAs with proven cardiovascular benefit (SGLT2 inhibitors: empagliflozin, dapagliflozin, or canagliflozin; GLP-1RAs: liraglutide, semaglutide, or dulaglutide), or metformin monotherapy with hemoglobin A1c \< 7%.

Secondary Outcome Measures

Name	Time	Method
Number of Participants on Guideline Recommended Therapies at Last Follow-up Visit.	Up to 12 Months	Number of participants prescribed each of the 3 recommended therapies at the last follow-up visit.
Change in Average LDL-C From Baseline to Last Follow-up Visit.	Baseline and last follow-up visit (up to 12 months)	Average change in LDL-C values between baseline visit and last follow-up visit.
Number of Participants With LDL-C < 70 mg/dL	Baseline and last follow-up visit (up to 12 months)	Change in number of participants with LDL-C \< 70 mg/dL at baseline visit vs. last follow-up visit.
Change in Average Blood Pressure From Baseline to Last Follow-up Visit.	Baseline and last follow-up visit (up to 12 months)	Change in systolic and diastolic blood pressure from baseline to last follow-up visit.
Number of Participants With sBP < 130 mmHg	Baseline and last follow-up visit (up to 12 months)	Proportion of participants achieving sBP \< 130 mmHg at baseline vs. last follow-up visit
Number of Participants With dBP < 180 mmHg	Baseline and last follow-up visit (up to 12 months)	Change in number of participants with dBP \< 180 mmHg from baseline to last follow-up visit
Change in Average HbA1c From Baseline to Last Follow-up Visit.	Baseline and last follow-up visit (up to 12 months)	Change in hemoglobin A1c (HbA1c) between baseline and last follow-up visit.
Number of Participants With HbA1c < 7%	Baseline and last follow-up visit (up to 12 months)	Change in number of participants with HbA1c \< 7% from baseline to last follow-up visit.
Number of Participants Experiencing an Event Within 1 Year	Up to 12 Months	Number of participants experiencing an event within 12 months of enrollment. Also known as cumulative incidence of events.

Trial Locations

Locations (44)

Stanford University; 🇺🇸 Stanford, California, United States

Bayfront Cardiovascular Associates; 🇺🇸 Saint Petersburg, Florida, United States

Citrus Cardiology; 🇺🇸 Inverness, Florida, United States

Advanced Research for Health Improvement, LLC; 🇺🇸 Naples, Florida, United States

Baptist Health Research Institute; 🇺🇸 Jacksonville, Florida, United States

Blue Coast Cardiology; 🇺🇸 Vista, California, United States

Heart Clinic of Louisiana; 🇺🇸 Marrero, Louisiana, United States

Cape Fear Heart Associates; 🇺🇸 Wilmington, North Carolina, United States

Advanced Heart Care Group/Medicoricium LLC; 🇺🇸 Fairview Heights, Illinois, United States

Endeavor Medical Research; 🇺🇸 Alpena, Michigan, United States

Orlando Heart and Vascular Institute; 🇺🇸 Altamonte Springs, Florida, United States

Iowa Heart Center; 🇺🇸 Des Moines, Iowa, United States

Prairie Cardiovascular Consultants; 🇺🇸 Springfield, Illinois, United States

Advanced Heartcare LLC; 🇺🇸 Bridgewater, New Jersey, United States

Hannibal Regional Medical Group; 🇺🇸 Hannibal, Missouri, United States

Bridgeport Hospital; 🇺🇸 Bridgeport, Connecticut, United States

Riverside Medical Center/Synergy Healthcare; 🇺🇸 Bradenton, Florida, United States

Advocate Heart Institute; 🇺🇸 Chicago, Illinois, United States

The Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Cardiology Institute of Michigan; 🇺🇸 Flint, Michigan, United States

Northwell Health/Lenox Hill Hospital; 🇺🇸 Manhasset, New York, United States

Guthrie Medical Group; 🇺🇸 Sayre, Pennsylvania, United States

Lonestar Heart and Vascular; 🇺🇸 Tomball, Texas, United States

Cardiovascular Associates of the Delaware Valley; 🇺🇸 Sewell, New Jersey, United States

New Jersey Heart; 🇺🇸 Linden, New Jersey, United States

Aurora Denver Cardiology; 🇺🇸 Denver, Colorado, United States

Grandview Health/Alabama Cardiovascular Group; 🇺🇸 Birmingham, Alabama, United States

USA Cardiology; 🇺🇸 Mobile, Alabama, United States

Kernodle Clinic; 🇺🇸 Burlington, North Carolina, United States

Dignity Health/DHMG Specialty Medicine; 🇺🇸 Phoenix, Arizona, United States

Cardiovascular Health Clinic; 🇺🇸 Oklahoma City, Oklahoma, United States

Lennar Foundation/Univ. of Miami; 🇺🇸 Coral Gables, Florida, United States

Interventional Cardiac Consultants; 🇺🇸 Trinity, Florida, United States

Cardiovascular Inst. of Northwest Florida; 🇺🇸 Panama City, Florida, United States

Specialty Physicians of Illinois; 🇺🇸 Olympia Fields, Illinois, United States

Cone Health/LeBauer Brodie Ctr for Cardiovascular Rsch; 🇺🇸 Greensboro, North Carolina, United States

Univ. of Texas Southwestern; 🇺🇸 Dallas, Texas, United States

Emory/Grady Memorial Hospital; 🇺🇸 Atlanta, Georgia, United States

UnityPoint Health Cardiovascular Services; 🇺🇸 Peoria, Illinois, United States

Garden State Heart Care; 🇺🇸 Manalapan, New Jersey, United States

Alaska Heart and Vascular Institute; 🇺🇸 Anchorage, Alaska, United States

ProHealth Care Heart and Vascular; 🇺🇸 Waukesha, Wisconsin, United States

Advanced Cardiology Associates; 🇺🇸 Greenwood, South Carolina, United States

Black Hills Cardiovascular Research; 🇺🇸 Rapid City, South Dakota, United States