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

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Duke University

Status

Active, not recruiting

Conditions

Cardiovascular Diseases
Diabetes Mellitus, Type 2

Treatments

Other: Intense Education Intervention

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03936660
Pro00101556

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,049 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,049 participants in 2 patient groups

Control
No Intervention group
Description:
Clinics in the control arm will be encouraged to follow guideline-based care.
Intervention
Active Comparator group
Description:
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.
Treatment:
Other: Intense Education Intervention

Trial contacts and locations

44

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Data sourced from clinicaltrials.gov

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