A 12 Month Site Randomized Trial in Adults With Type 2 Diabetes Mellitus and History of Cardiovascular Disease (COORDINATE)
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|ClinicalTrials.gov Identifier: NCT03936660|
Recruitment Status : Recruiting
First Posted : May 3, 2019
Last Update Posted : March 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2 Cardiovascular Diseases||Other: Intense Education Intervention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1380 participants|
|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|
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
- 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.
- Proportion of patients on guideline recommended therapies at 12 months. [ Time Frame: 12 Months ]
- Changes in cholesterol levels over 12 months. [ Time Frame: Baseline and 12 Months ]
- Changes in blood pressure control over 12 months. [ Time Frame: Baseline and 12 Months ]
- Changes in glycemic control over 12 months [ Time Frame: Baseline and 12 Months ]
- Measurement of average time from baseline to patient event. [ Time Frame: 12 Months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03936660
|Contact: Laura Webbfirstname.lastname@example.org|
|Contact: Nina Hinesemail@example.com|
|Principal Investigator:||Christopher Granger, MD||Duke Clinical Research Institute|