Integrated Diabetes Care for Cardiovascular Disease Risk Management

(D4C Trial)

Recruiting at 1 trial location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Tulane University

No Placebo Group

Trial Summary

What is the purpose of this trial?

The overall objective of the proposed cluster randomized trial is to test whether implementation of protocol-based integrated care will improve CVD risk factors (glycated hemoglobin \[HbA1C\], systolic blood pressure \[SBP\], and LDL-cholesterol) over 18 months and reduce major CVD events (non-fatal stroke, non-fatal myocardial infarction, hospitalized heart failure, and CVD mortality) over 3 years among patients with type 2 diabetes and additional CVD risk factors or clinical CVD compared to usual team-based care in community clinics in Xiamen, China.

Research Team

Jiang He, MD, PhD

Principal Investigator

Tulane University

Eligibility Criteria

This trial is for men and women over 50 with uncontrolled diabetes (HbA1C ≥7%) and additional cardiovascular risk factors or clinical CVD, who are not pregnant, can be followed for 36 months, can give consent, and have no heart failure requiring intense treatment or contraindications to common diabetes medications.

Inclusion Criteria

Men or women who are 50 years old or older and get their main healthcare from the clinics taking part in the study.

Your diabetes is not well controlled, and you have other risk factors for heart disease, or you have a history of certain heart or blood vessel problems.

Exclusion Criteria

Patients who are unwilling or unable to give informed consent

You have moderate to severe heart failure, are receiving hemodialysis, or cannot take metformin or statin medications.

Women who are pregnant or plan to become pregnant

Treatment Details

Interventions

• Protocol-based integrated care (Behavioural Intervention)

Trial Overview The D4C Trial is testing if a protocol-based integrated care approach improves cardiovascular disease risk factors in diabetic patients over 18 months and reduces major CVD events over three years compared to usual care in community clinics in Xiamen, China.

Participant Groups

Group I: Protocol-based Integrated Care Experimental Treatment 1 Intervention

The protocol-based integrated care, which will provide a standardized, combined, multi-component intervention according to clinical guideline treatment algorithms for diabetes and comorbidities in community clinics, will be delivered by care team (trained primary care physicians, health managers, and nurses supported by diabetes specialists) and assisted by a clinical decision support systems.

Group II: Enhanced Control Active Control 1 Intervention

A usual team-based care delivered by trained primary care physicians, health managers, and nurses supported by diabetes specialists.

Who Is Running the Clinical Trial?

Tulane University

Lead Sponsor

Trials

129

Recruited

259,000+

James Zanewicz

Tulane University

Chief Medical Officer

MD from Tulane University

Elaine Hamm

Tulane University

Chief Executive Officer since 2022

PhD in Microbiology from the University of Oklahoma

Xiamen Ophthalmology Center Affiliated to Xiamen University

Collaborator

Trials

23

Recruited

200,000+

Xiamen University

Collaborator

Trials

25

Recruited

1,533,000+