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

November 15, 2024 updated by: Duke University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1049

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35243
        • Grandview Health/Alabama Cardiovascular Group
      • Mobile, Alabama, United States, 36617
        • USA Cardiology
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Alaska Heart and Vascular Institute
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Dignity Health/DHMG Specialty Medicine
    • California
      • Stanford, California, United States, 94305
        • Stanford University
      • Vista, California, United States, 92083
        • Blue Coast Cardiology
    • Colorado
      • Denver, Colorado, United States, 80012
        • Aurora Denver Cardiology
    • Connecticut
      • Bridgeport, Connecticut, United States, 06610
        • Bridgeport Hospital
    • Florida
      • Altamonte Springs, Florida, United States, 32714
        • Orlando Heart and Vascular Institute
      • Bradenton, Florida, United States, 34208
        • Riverside Medical Center/Synergy Healthcare
      • Coral Gables, Florida, United States, 33146
        • Lennar Foundation/Univ. of Miami
      • Inverness, Florida, United States, 34452
        • Citrus Cardiology
      • Jacksonville, Florida, United States, 32258
        • Baptist Health Research Institute
      • Naples, Florida, United States, 34102
        • Advanced Research for Health Improvement, LLC
      • Panama City, Florida, United States, 32401
        • Cardiovascular Inst. of Northwest Florida
      • Saint Petersburg, Florida, United States, 33701
        • Bayfront Cardiovascular Associates
      • Trinity, Florida, United States, 34655
        • Interventional Cardiac Consultants
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Emory/Grady Memorial Hospital
    • Illinois
      • Chicago, Illinois, United States, 60657
        • Advocate Heart Institute
      • Fairview Heights, Illinois, United States, 62208
        • Advanced Heart Care Group/Medicoricium LLC
      • Olympia Fields, Illinois, United States, 60461
        • Specialty Physicians of Illinois
      • Peoria, Illinois, United States, 61606
        • UnityPoint Health Cardiovascular Services
      • Springfield, Illinois, United States, 62701
        • Prairie Cardiovascular Consultants
    • Iowa
      • Des Moines, Iowa, United States, 50266
        • Iowa Heart Center
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • Heart Clinic of Louisiana
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • The Johns Hopkins University
    • Michigan
      • Alpena, Michigan, United States, 49707
        • Endeavor Medical Research
      • Flint, Michigan, United States, 48507
        • Cardiology Institute of Michigan
    • Missouri
      • Hannibal, Missouri, United States, 63401
        • Hannibal Regional Medical Group
    • New Jersey
      • Bridgewater, New Jersey, United States, 08807
        • Advanced Heartcare LLC
      • Linden, New Jersey, United States, 07036
        • New Jersey Heart
      • Manalapan, New Jersey, United States, 07726
        • Garden State Heart Care
      • Sewell, New Jersey, United States, 08080
        • Cardiovascular Associates of the Delaware Valley
    • New York
      • Manhasset, New York, United States, 11030
        • Northwell Health/Lenox Hill Hospital
    • North Carolina
      • Burlington, North Carolina, United States, 27215
        • Kernodle Clinic
      • Greensboro, North Carolina, United States, 27401
        • Cone Health/LeBauer Brodie Ctr for Cardiovascular Rsch
      • Wilmington, North Carolina, United States, 28401
        • Cape Fear Heart Associates
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73134
        • Cardiovascular Health Clinic
    • Pennsylvania
      • Sayre, Pennsylvania, United States, 18840
        • Guthrie Medical Group
    • South Carolina
      • Greenwood, South Carolina, United States, 29646
        • Advanced Cardiology Associates
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Black Hills Cardiovascular Research
    • Texas
      • Dallas, Texas, United States, 75390
        • Univ. of Texas Southwestern
      • Tomball, Texas, United States, 77375
        • Lonestar Heart and Vascular
    • Wisconsin
      • Waukesha, Wisconsin, United States, 53188
        • ProHealth Care Heart and Vascular

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Clinics provided with existing clinical care guidelines.
Active Comparator: Intervention
Clinics provided with existing clinical care guidelines as well as a multifaceted educational intervention to support development of an integrated, multi-disciplinary care pathway for patients with T2DM and CVD.
Other: Intense Education Intervention
Clinics provided with existing clinical care guidelines as well as a multifaceted educational intervention to support development of an integrated, multi-disciplinary care pathway for patients with T2DM and CVD.
Other Names:
  • Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Prescribed All 3 Groups of Recommended Evidence-based Medications
Time Frame: 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%.
Up to 12 Months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Eli Lilly and Company
Boehringer Ingelheim

Investigators

  • Principal Investigator: Christopher Granger, MD, Duke Clinical Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2019

Primary Completion (Actual)

December 30, 2022

Study Completion (Actual)

December 30, 2022

Study Registration Dates

First Submitted

May 1, 2019

First Submitted That Met QC Criteria

May 1, 2019

First Posted (Actual)

May 3, 2019

Study Record Updates

Last Update Posted (Actual)

November 21, 2024

Last Update Submitted That Met QC Criteria

November 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00101556

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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