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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1049

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eli Lilly and Company
Boehringer Ingelheim

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 25, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 1, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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