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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03936660
Recruitment Status : Recruiting
First Posted : May 3, 2019
Last Update Posted : March 24, 2020
Sponsor:
Collaborators:
Boehringer Ingelheim
Eli Lilly and Company
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Cardiovascular Diseases Other: Intense Education Intervention Not Applicable

Detailed Description:

Patients with Type 2 diabetes mellitus and a history of cardiovascular disease will be enrolled in this study. The study will randomize 46 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: COOrdinating CaRDIology CliNics RAndomized Trial of Interventions to Improve OutcomEs (COORDINATE) - Diabetes
Actual Study Start Date : July 18, 2019
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : August 1, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
Clinics in the control arm will be encouraged to follow guideline-based care.
Active Comparator: 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.
Other: Intense Education Intervention
Intervention will involve guideline-based care education.
Other Name: Intervention




Primary Outcome Measures :
  1. Implementing a clinic-level multifaceted intervention [ Time Frame: 12 Months ]
    Proportion of patients achieving guideline-recommended management for T2DM and CVD at 12 months as prescribed by a cardiologist.


Secondary Outcome Measures :
  1. Proportion of patients on guideline recommended therapies at 12 months. [ Time Frame: 12 Months ]
  2. Changes in cholesterol levels over 12 months. [ Time Frame: Baseline and 12 Months ]
  3. Changes in blood pressure control over 12 months. [ Time Frame: Baseline and 12 Months ]
  4. Changes in glycemic control over 12 months [ Time Frame: Baseline and 12 Months ]
  5. Measurement of average time from baseline to patient event. [ Time Frame: 12 Months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03936660


Contacts
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Contact: Laura Webb 9196688977 laura.webb@duke.edu
Contact: Nina Hines 9196683637 nina.hines@duke.edu

Locations
Show Show 37 study locations
Sponsors and Collaborators
Duke University
Boehringer Ingelheim
Eli Lilly and Company
Investigators
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Principal Investigator: Christopher Granger, MD Duke Clinical Research Institute
Publications:

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03936660    
Other Study ID Numbers: Pro00101556
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
COORDINATE-DIABETES
COORDINATE
T2DM
Diabetes Mellitus, Type 2
Cardiovascular Disease
Prevention
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases