A Multi-site, Individually Randomized, Controlled Translation Trial of Integrated and Comprehensive Care Strategies to Reduce Cardiovascular Disease (CVD) Risk Among 1,120 Type 2 Diabetes Mellitus(T2DM) Patients in South Asia

Summary

Background: Cardiovascular diseases (CVD) are currently the leading cause of death globally and Asian Indians will account for between 40-60% of the global CVD burden within the next 10-15 years. Risk factor control and preventive care are effective in reducing CVD events and mortality. The greatest gains in CVD prevention have been seen when early and target-driven interventions address multiple risk factors together. However, achieving control of even individual risk factors (blood glucose, blood pressure, or blood lipid targets) is poor, globally. Quality improvement schemes, like the proposed intervention, have shown promise in high-income countries, but are untested in South Asia; a region with a population at extraordinarily high CVD risk.

Objective: To test whether a clinic-based case management intervention (consisting of guidelines based treatment, care coordinator assistance and decision support software) to reduce cardiovascular disease (CVD) risk among Type 2 diabetes patients in South Asia, is more effective and sustainable compared to existing care.

Trial subjects and methods: The study will involve a total of 1120 patients attending 8 established out-patient clinics in South Asia (140 patients at each clinic). Patients enrolled in the trial will be randomly assigned to either the control (existing care) or the intervention group and will be followed up for an average of 30 months. The total trial duration is about 3.5 years, from mid-August 2010 to December 31, 2013.

Conditions

• Type 2 Diabetes Mellitus
• Hypertension
• Dyslipidaemia

Interventions

OTHER

Care Coordinator + Decision Support Software

Care coordinator + Decision Support Software (Experimental Arm): The patients will receive integrated diabetes care management consisting of current diabetes management guidelines + Non-Physician care coordinator assistance + Electronic Health Records- Decision Support Software (EHR-DSS) (The software will generate diabetes management prompts for the treating physician and reminders for clinic visits for the intervention arm patients.)

OTHER

Usual care

Usual care (Active Comparator Arm): Patients will continue with the usual diabetes care with no care coordinator assistance and no decision support software - management prompt.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• United Health Group, USA

  collaborator UNKNOWN

• All India Institute of Medical Sciences

  collaborator OTHER

• Madras Diabetes Research Foundation, Chennai

  collaborator UNKNOWN

• Aga Khan University

  collaborator OTHER

• Public Health Foundation of India

  lead OTHER

Principal Investigators

• Dorairaj Prabhakaran, MD, DM, MSc. · Public Health Foundation of India

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

35 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-10-31

Primary Completion

2013-12-31

Completion

2014-06-30

Countries

• India
• Pakistan

Study Locations