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Completed

NCT Number: NCT03936660

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Grandview Health/Alabama Cardiovascular Group, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years old
  • Diagnosis of Type 2 diabetes mellitus (T2DM)
  • History of at least one of the following conditions:
  • Coronary artery disease (defined as prior MI, coronary revascularization (CABG or PCI), and/or obstructive CAD (≥50%) as documented by angiography or CTA)
  • Stroke and/or carotid artery stenosis (≥50%)
  • 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

Treatment and study plan

Intense Education Intervention

Other

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

Primary outcomes

  1. 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%.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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

  7. 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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Boehringer Ingelheim
  • Eli Lilly and Company

Registry information

Official study title

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

Acronym: COORDINATE

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 3, 2019
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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