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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 (CARRS)

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ClinicalTrials.gov Identifier: NCT01212328
Recruitment Status : Unknown
Verified September 2011 by Public Health Foundation of India.
Recruitment status was:  Recruiting
First Posted : September 30, 2010
Last Update Posted : September 5, 2011
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
United Health Group, USA
All India Institute of Medical Sciences, New Delhi
Madras Diabetes Research Foundation, Chennai
Aga Khan University
Information provided by (Responsible Party):
Public Health Foundation of India

Study Description
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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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Hypertension Dyslipidaemia Other: Care Coordinator + Decision Support Software Other: Usual care Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Developing and Testing Integrated, Multi-factorial Cardiovascular Disease Risk Reduction Strategies in South Asia (CARRS Translation Trial)
Study Start Date : October 2010
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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: 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.)
Active Comparator: 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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Multiple CVD risk factor control targets [ Time Frame: 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 :
  1. Single risk factor control of at least one target either HbA1c or blood pressure or LDL-Cholesterol [ Time Frame: 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)

  2. The cost effectiveness analysis of the intervention compared to the usual care. [ Time Frame: 42 months after randomization ]
  3. Quality of life [ Time Frame: 42 months after randomization ]
  4. Prescriber and patient acceptability of the Digital Support software and care coordinator with management guidelines. [ Time Frame: 42 months after randomization ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01212328


Contacts
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Contact: Kavita Singh, MSc. +91-11-26850118 ext 39 kavita@ccdcindia.org

Locations
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India
Bangalore Endocrinology and Diabetes Research Centre, Recruiting
#35, 5th Cross,Malleswaram Circle,, Bangalore, Karnataka, India, 560 003
Contact: Mala Dharmalingam, MD DM    +919845208163    drmala@bedrc.com   
Principal Investigator: Mala Dharamalingam, MD DM         
St. John's Medical College & Hospital, Recruiting
Sarjapur Road, Koramangala,, Bangalore, India, 560 034
Contact: Ganapathy Bantwal, MD DM    +919448067318    mallyaganapathi@rediffmail.com   
Principal Investigator: Ganapathy Bantwal, MD DM         
Diabetes Research Centre & MV Hospital for Diabetes, Recruiting
No 4 West Madha Church Street, Royapuram, Chennai, India, 600 013
Contact: Vijay Viswanathan, MD DM    +919840055535    dr_vijay@vsnl.com   
Principal Investigator: Vijay Vishwanatha, MD DM         
Public Health Foundation of India Recruiting
New Delhi, Delhi, India, 110016
Contact: Dorairaj Prabhakaran, MD, DM, MSc.    +91-11-26850588    dprabhakaran@ccdcindia.org   
Principal Investigator: Nikhil Tandon, MD, PhD         
Endocrine Division, Department of Medicine, Goa Medical College, Not yet recruiting
Bambolim, Goa, India, 403202
Contact: Ankush Desai, MD DM    +91-9923486199    ankush_desai@rediffmail.com   
Principal Investigator: Ankush Desai, MD DM         
Department of Endocrinology, CARE Hospital, Recruiting
Road No 1, Banjara Hills,, Hyderabad,, India, 500 034
Contact: Bipin Sethi, MD, DM    +919848021482    bipinkumarsethi@yahoo.co.uk   
Principal Investigator: Bipin Sethi, MD, DM         
Osmania General Hospital, Recruiting
2nd Floor, Golden Jubilee Block, Afzalgunj,, Hyderabad, India, 500012
Contact: Rakesh Sahay, MD DM    +919849597507    sahayrk@gmail.com   
Principal Investigator: Rakesh Sahay, MD DM         
Amrita Institute of Medical Sciences Recruiting
Kochi, Kerala, India, 682041
Contact: A G Unnikrishnan, MD, DM    +91-4844001559    unnikrishnanag@aims.amrita.edu   
Principal Investigator: A G Unnikrishnan, Md, DM         
Topiwala National Medical College & BYL Nair Ch. Hospital, Recruiting
Dr. A. L. Nair Road, Mumbai Central,, Mumbai, India, 400 008
Contact: Premalata Varthakavi, MD, DM    +919224480560    premavar@hotmail.com   
Principal Investigator: Premlatha Varthakavi, MD, DM         
Pakistan
Department of CHS, The Aga Khan, University, Recruiting
P.O. BOx. 3500 Stadium, Road,, Karachi, Pakistan, 74800
Contact: Hassan Daudzai, MBBS    +92214930051 ext 4919    hassan.daudzai@aku.edu   
Principal Investigator: Abdul Jabbar, MD DM         
Sponsors and Collaborators
Public Health Foundation of India
National Heart, Lung, and Blood Institute (NHLBI)
United Health Group, USA
All India Institute of Medical Sciences, New Delhi
Madras Diabetes Research Foundation, Chennai
Aga Khan University
Investigators
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Principal Investigator: Dorairaj Prabhakaran, MD, DM, MSc. Public Health Foundation of India
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Public Health Foundation of India
ClinicalTrials.gov Identifier: NCT01212328    
Other Study ID Numbers: UTRN 022342347-29072010248
First Posted: September 30, 2010    Key Record Dates
Last Update Posted: September 5, 2011
Last Verified: September 2011
Keywords provided by Public Health Foundation of India:
T2DM
Decision support software
care coordinator
Additional relevant MeSH terms:
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Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Dyslipidemias
 Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lipid Metabolism Disorders