Diabetes Complication Control in Community Clinics (D4C) Trial

NCT02835287 | Unknown

• 1 other identifier: 889920-1
• Study Type: interventional
• Target: 11,132
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Diabetes; Hypertension; Dyslipidemia; Cardiovascular Disease

Outcome Measures

Primary Outcomes (2)

• Change in HbA1C, SBP, and LDL between intervention and control groups, simultaneously modeled using a scaled marginal model which allows estimation of a single overall treatment effect and combined control rate of HbA1c, SBP, and LDL

  For patients younger than 65 years, HbA1c ≤7.0% or ≤8.0% in those with complications; for patients 65 years or older, HbA1c ≤7.5% or HbA1c ≤8.5% in those with complications; LDL-cholesterol \<100 mg/dL; and blood pressure \<140/90 mm Hg

  18 months

• Incidence of composite major cardiovascular disease events

  Non-fatal stroke, non-fatal myocardial infarction, hospitalized heart failure, and CVD mortality

  Three years

Secondary Outcomes (6)

• HbA1C

  18 months

• SBP

  18 months

• LDL-cholesterol

  18 months

• CVD risk score

  18 months

• Health-related quality of life: 12-item Short-Form Health Survey

  Three years

Study Arms (2)

Protocol-based Integrated Care

EXPERIMENTAL

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.

Other: Protocol-based integrated care

Enhanced Control

ACTIVE COMPARATOR

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

Other: Protocol-based integrated care

Interventions

Protocol-based integrated care OTHER

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 trained primary care physicians, health managers, and nurses supported by diabetes specialists.

Enhanced Control; Protocol-based Integrated Care

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women aged ≥50 years who received primary care from the participating community clinics
• Uncontrolled diabetes (HbA1C ≥7% or ≥7.5% if with clinical CVD) with at least one additional CVD risk factor (SBP ≥140 and/or DBP ≥90 mm Hg and/or LDL-cholesterol ≥100 mg/dL) or clinical ASCVD (acute coronary syndromes, ischemic stroke, transient ischemic attack, or peripheral artery disease)

You may not qualify if:

• Patients with NYHA class II-IV heart failure, or receiving hemodialysis, or with contraindications to metformin or statin treatments
• Women who are pregnant or plan to become pregnant
• Patients who cannot be followed for 36 months (due to a health situation or migration)
• Patients who are unwilling or unable to give informed consent

Sponsors & Collaborators

• Tulane University: lead
• Xiamen University: collaborator

Study Sites (2)

Tulane University

New Orleans, Louisiana, 70112, United States

Location

Xiamen Diabetes Institute, Xiamen University

Xiamen, Fujian, 361003, China

Location

Related Publications (1)

• Shi X, He J, Lin M, Liu C, Yan B, Song H, Wang C, Xiao F, Huang P, Wang L, Li Z, Huang Y, Zhang M, Chen CS, Obst K, Shi L, Li W, Yang S, Yao G, Li X. Comparative Effectiveness of Team-Based Care With and Without a Clinical Decision Support System for Diabetes Management : A Cluster Randomized Trial. Ann Intern Med. 2023 Jan;176(1):49-58. doi: 10.7326/M22-1950. Epub 2022 Dec 6.

  PMID: 36469915 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Hypertension; Dyslipidemias; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Lipid Metabolism Disorders

Study Officials

• Jiang He, MD, PhD

  Tulane University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair

Study Record Dates

• First Submitted: July 6, 2016
• First Posted: July 18, 2016
• Study Start: October 26, 2016
• Primary Completion: December 30, 2023
• Study Completion: December 31, 2023
• Last Updated: November 2, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1); US (1)