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

Hypertension Clinical Trial

— CARRS  

Official title:

Developing and Testing Integrated, Multi-factorial Cardiovascular Disease Risk Reduction Strategies in South Asia (CARRS Translation Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01212328
• Other study ID #: UTRN 022342347-29072010248
• Status: Recruiting
• Phase: N/A
• First received: September 6, 2010
• Last updated: September 2, 2011
• Start date: October 2010
• Est. completion date: June 2014

Study information

• Verified date: September 2011
• Source: Public Health Foundation of India
• Contact: Kavita Singh, MSc.
• Phone: +91-11-26850118
• Email: kavita[@]ccdcindia.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board, Emory UniversityIndia: Institutional Review Board, Public Health Foundation of India
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1120
• Est. completion date: June 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Dyslipidaemia
• Dyslipidemias
• Hypertension
• Type 2 Diabetes Mellitus

Intervention

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.)
• 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.

Locations

Country	Name	City	State
India	Bangalore Endocrinology and Diabetes Research Centre,	#35, 5th Cross,Malleswaram Circle,	Bangalore, Karnataka
India	Osmania General Hospital,	2nd Floor, Golden Jubilee Block, Afzalgunj,	Hyderabad
India	Endocrine Division, Department of Medicine, Goa Medical College,	Bambolim	Goa
India	Topiwala National Medical College & BYL Nair Ch. Hospital,	Dr. A. L. Nair Road, Mumbai Central,	Mumbai
India	Amrita Institute of Medical Sciences	Kochi	Kerala
India	Public Health Foundation of India	New Delhi	Delhi
India	Diabetes Research Centre & MV Hospital for Diabetes,	No 4 West Madha Church Street, Royapuram	Chennai
India	Department of Endocrinology, CARE Hospital,	Road No 1, Banjara Hills,	Hyderabad,
India	St. John's Medical College & Hospital,	Sarjapur Road, Koramangala,	Bangalore
Pakistan	Department of CHS, The Aga Khan, University,	P.O. BOx. 3500 Stadium, Road,	Karachi

Sponsors (6)

Lead Sponsor	Collaborator
Public Health Foundation of India	Aga Khan University, All India Institute of Medical Sciences, New Delhi, Madras Diabetes Research Foundation, Chennai, National Heart, Lung, and Blood Institute (NHLBI), United Health Group, USA

Countries where clinical trial is conducted

India,  Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Multiple CVD risk factor control targets	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)	42 months after randomization	Yes
Secondary	Single risk factor control of at least one target either HbA1c or blood pressure or LDL-Cholesterol	Single risk factor control; absolute 10% point greater proportion of participants in the intervention group achieving good glycemic control (HbA1c < 7%); systolic BP < 130 and diastolic BP < 80 mmHg; LDL-cholesterol < 100 mg/dl, < 70 mg/dl for those with history of CVD event)	42 months after randomization	Yes
Secondary	The cost effectiveness analysis of the intervention compared to the usual care.		42 months after randomization	No
Secondary	Quality of life		42 months after randomization	No
Secondary	Prescriber and patient acceptability of the Digital Support software and care coordinator with management guidelines.		42 months after randomization	No