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

Not Applicable

• Conditions: Type 2 Diabetes Mellitus; Hypertension; Dyslipidaemia
• Interventions: Other: Usual care; Other: Care Coordinator + Decision Support Software

• Registration Number: NCT01212328
• Lead Sponsor: Public Health Foundation of India

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-06
• Study First Submitted QC: 2010-09-29
• Study First Posted: 2010-09-30
• Study Start: 2010-10
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-02
• Last Update Posted: 2011-09-05
• Primary Completion: 2013-12
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1120

Inclusion Criteria

1. Age 35 years and older
2. Confirmed diagnosis of diabetes based on documented evidence from oral glucose tolerance test or two venous fasting blood sugar levels or known diabetes patient on medication or insulin
3. Poor glycemic control (as evidenced by HbA1c >=8.0%) and one or both of: dyslipidemia [Low density Lipoprotein (LDL) >=130 mg/dl] or systolic hypertension [Systolic Blood Pressure (SBP) >=140 mmHg], irrespective of lipid- or BP-lowering medication use, respectively
4. Receiving diabetes care in the same clinic for at least 3 months OR even earlier if in the investigator's assessment the patient is likely to follow-up regularly as required by the protocol.
5. Willingness to consent to randomization.

Exclusion Criteria

Individuals will be excluded from participation if any of the following are present during screening:

1. Known type 1 diabetes mellitus
2. Diabetes secondary to chronic pancreatitis
3. Pregnant OR trying to become pregnant OR of child-bearing potential and not actively practicing birth control (including natural methods)
4. Evidence of pre-existing well-controlled blood glucose, blood pressure or LDL-cholesterol (as evidenced by HbA1c < 7.0%, SBP < 130 mmHg, LDL-cholesterol < 100 mg/dl [LDL-cholesterol < 70 mg/dl with history of CVD event]) obtained from screening within a period not exceeding 28 days (4 weeks) prior to randomization
5. Documented cardiovascular event (coronary revascularization, stroke, MI, unstable angina) in past 12 months
6. Current symptomatic Congestive Heart Failure (CHF) or New York Heart Association (NYHA) Class 3 or 4 effort intolerance
7. Documented non-diabetic kidney disease OR pre-existing end -stage renal disease (on renal replacement therapy [dialysis or transplant])
8. Transaminase >3 times upper limit of normal OR active liver disease within past 2 years
9. Malignancy or life-threatening disease with death probable in 4 years
10. Any current medication (e.g. long-term steroids, protease inhibitors) that, in the opinion of the site investigator, would interfere with participant's diabetic status and follow-up
11. Any condition or circumstance that is unrelated to diabetes progression, that in the opinion of the site investigator would interfere with the participant's diabetic status and follow-up: including (but not limited to) other endocrinopathy [adrenal, pituitary], Tuberculosis (TB) patient on treatment, psychiatric illness or cognitive impairment, alcohol or drug abuse, history of organ transplant, Body Mass index (BMI) >= 45 kg/m2
12. On an investigational drug in the last 3 months
13. Currently participating in a clinical trial
14. No fixed address or contact details
15. Plans to move in the next 3 years
16. A member of the participant's household is currently in the trial
17. Inability or unwillingness of individual or legal guardian /representative to give written informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care	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.
Care coordinator + Decision Support Software	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.)

Primary Outcome Measures

Name	Time	Method
Multiple CVD risk factor control targets	42 months after randomization	The study has one primary outcome of interest, multiple CVD risk factor control targets: at least two targets including Hemoglobin A1c (HbA1c) \< 7.0% and at least one of: Blood Pressure (BP) \< 130/80 mmHg or Low Density Lipoprotein (LDL)-cholesterol \< 100 mg/dl (LDL cholesterol \< 70 mg/dl for those with history of CVD event)

Secondary Outcome Measures

Name	Time	Method
Single risk factor control of at least one target either HbA1c or blood pressure or LDL-Cholesterol	42 months after randomization	Single risk factor control; 1. absolute 10% point greater proportion of participants in the intervention group achieving good glycemic control (HbA1c \< 7%); 2. systolic BP \< 130 and diastolic BP \< 80 mmHg; 3. LDL-cholesterol \< 100 mg/dl, \< 70 mg/dl for those with history of CVD event)
The cost effectiveness analysis of the intervention compared to the usual care.	42 months after randomization
Quality of life	42 months after randomization
Prescriber and patient acceptability of the Digital Support software and care coordinator with management guidelines.	42 months after randomization

Trial Locations

Locations (10)

Osmania General Hospital,; 🇮🇳 2nd Floor, Golden Jubilee Block, Afzalgunj,, Hyderabad, India

St. John's Medical College & Hospital,; 🇮🇳 Sarjapur Road, Koramangala,, Bangalore, India

Diabetes Research Centre & MV Hospital for Diabetes,; 🇮🇳 No 4 West Madha Church Street, Royapuram, Chennai, India

Topiwala National Medical College & BYL Nair Ch. Hospital,; 🇮🇳 Dr. A. L. Nair Road, Mumbai Central,, Mumbai, India

Department of Endocrinology, CARE Hospital,; 🇮🇳 Road No 1, Banjara Hills,, Hyderabad,, India

Endocrine Division, Department of Medicine, Goa Medical College,; 🇮🇳 Bambolim, Goa, India

Amrita Institute of Medical Sciences; 🇮🇳 Kochi, Kerala, India

Department of CHS, The Aga Khan, University,; 🇵🇰 P.O. BOx. 3500 Stadium, Road,, Karachi, Pakistan

Bangalore Endocrinology and Diabetes Research Centre,; 🇮🇳 #35, 5th Cross,Malleswaram Circle,, Bangalore, Karnataka, India

Public Health Foundation of India; 🇮🇳 New Delhi, Delhi, India