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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)

Primary Purpose

Type 2 Diabetes Mellitus, Hypertension, Dyslipidaemia

Status

Unknown status

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Care Coordinator + Decision Support Software

Usual care

About this trial

This is an interventional prevention trial for Type 2 Diabetes Mellitus focused on measuring T2DM, Decision support software, care coordinator

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 35 years and older
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
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
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.
Willingness to consent to randomization.

Exclusion Criteria:

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

Known type 1 diabetes mellitus
Diabetes secondary to chronic pancreatitis
Pregnant OR trying to become pregnant OR of child-bearing potential and not actively practicing birth control (including natural methods)
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
Documented cardiovascular event (coronary revascularization, stroke, MI, unstable angina) in past 12 months
Current symptomatic Congestive Heart Failure (CHF) or New York Heart Association (NYHA) Class 3 or 4 effort intolerance
Documented non-diabetic kidney disease OR pre-existing end -stage renal disease (on renal replacement therapy [dialysis or transplant])
Transaminase >3 times upper limit of normal OR active liver disease within past 2 years
Malignancy or life-threatening disease with death probable in 4 years
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
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
On an investigational drug in the last 3 months
Currently participating in a clinical trial
No fixed address or contact details
Plans to move in the next 3 years
A member of the participant's household is currently in the trial
Inability or unwillingness of individual or legal guardian /representative to give written informed consent

Sites / Locations

Bangalore Endocrinology and Diabetes Research Centre,Recruiting
St. John's Medical College & Hospital,Recruiting
Diabetes Research Centre & MV Hospital for Diabetes,Recruiting
Public Health Foundation of IndiaRecruiting
Endocrine Division, Department of Medicine, Goa Medical College,
Department of Endocrinology, CARE Hospital,Recruiting
Osmania General Hospital,Recruiting
Amrita Institute of Medical SciencesRecruiting
Topiwala National Medical College & BYL Nair Ch. Hospital,Recruiting
Department of CHS, The Aga Khan, University,Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Care coordinator + Decision Support Software

Usual care

Arm Description

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)

The cost effectiveness analysis of the intervention compared to the usual care.

Quality of life

Prescriber and patient acceptability of the Digital Support software and care coordinator with management guidelines.

Full Information

NCT ID

NCT01212328

First Posted

September 6, 2010

Last Updated

September 2, 2011

Sponsor

Public Health Foundation of India

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

1. Study Identification

Unique Protocol Identification Number

NCT01212328

Brief Title

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

Acronym

CARRS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2011

Overall Recruitment Status

Unknown status

Study Start Date

October 2010 (undefined)

Primary Completion Date

December 2013 (Anticipated)

Study Completion Date

June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Public Health Foundation of India

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus, Hypertension, Dyslipidaemia

Keywords

T2DM, Decision support software, care coordinator

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Care coordinator + Decision Support Software

Arm Type

Experimental

Arm Description

Arm Title

Usual care

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Care Coordinator + Decision Support Software

Intervention Description

Intervention Type

Other

Intervention Name(s)

Usual care

Intervention Description

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.

Primary Outcome Measure Information:

Title

Multiple CVD risk factor control targets

Description

Time Frame

42 months after randomization

Secondary Outcome Measure Information:

Title

Single risk factor control of at least one target either HbA1c or blood pressure or LDL-Cholesterol

Description

Time Frame

42 months after randomization

Title

The cost effectiveness analysis of the intervention compared to the usual care.

Time Frame

42 months after randomization

Title

Quality of life

Time Frame

42 months after randomization

Title

Prescriber and patient acceptability of the Digital Support software and care coordinator with management guidelines.

Time Frame

42 months after randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 35 years and older 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 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 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. Willingness to consent to randomization. Exclusion Criteria: Individuals will be excluded from participation if any of the following are present during screening: Known type 1 diabetes mellitus Diabetes secondary to chronic pancreatitis Pregnant OR trying to become pregnant OR of child-bearing potential and not actively practicing birth control (including natural methods) 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 Documented cardiovascular event (coronary revascularization, stroke, MI, unstable angina) in past 12 months Current symptomatic Congestive Heart Failure (CHF) or New York Heart Association (NYHA) Class 3 or 4 effort intolerance Documented non-diabetic kidney disease OR pre-existing end -stage renal disease (on renal replacement therapy [dialysis or transplant]) Transaminase >3 times upper limit of normal OR active liver disease within past 2 years Malignancy or life-threatening disease with death probable in 4 years 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 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 On an investigational drug in the last 3 months Currently participating in a clinical trial No fixed address or contact details Plans to move in the next 3 years A member of the participant's household is currently in the trial Inability or unwillingness of individual or legal guardian /representative to give written informed consent

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kavita Singh, MSc.

Phone

+91-11-26850118

Ext

kavita@ccdcindia.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dorairaj Prabhakaran, MD, DM, MSc.

Organizational Affiliation

Public Health Foundation of India

Official's Role

Principal Investigator

Facility Information:

Facility Name

Bangalore Endocrinology and Diabetes Research Centre,

City

#35, 5th Cross,Malleswaram Circle,

State/Province

Bangalore, Karnataka

ZIP/Postal Code

560 003

Country

India

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mala Dharmalingam, MD DM

Phone

+919845208163

drmala@bedrc.com

First Name & Middle Initial & Last Name & Degree

Mala Dharamalingam, MD DM

Facility Name

St. John's Medical College & Hospital,

City

Sarjapur Road, Koramangala,

State/Province

Bangalore

ZIP/Postal Code

560 034

Country

India

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ganapathy Bantwal, MD DM

Phone

+919448067318

mallyaganapathi@rediffmail.com

First Name & Middle Initial & Last Name & Degree

Ganapathy Bantwal, MD DM

Facility Name

Diabetes Research Centre & MV Hospital for Diabetes,

City

No 4 West Madha Church Street, Royapuram

State/Province

Chennai

ZIP/Postal Code

600 013

Country

India

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Vijay Viswanathan, MD DM

Phone

+919840055535

dr_vijay@vsnl.com

First Name & Middle Initial & Last Name & Degree

Vijay Vishwanatha, MD DM

Facility Name

Public Health Foundation of India

City

New Delhi

State/Province

Delhi

ZIP/Postal Code

110016

Country

India

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dorairaj Prabhakaran, MD, DM, MSc.

Phone

+91-11-26850588

dprabhakaran@ccdcindia.org

First Name & Middle Initial & Last Name & Degree

Nikhil Tandon, MD, PhD

Facility Name

Endocrine Division, Department of Medicine, Goa Medical College,

City

Bambolim

State/Province

Goa

ZIP/Postal Code

403202

Country

India

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ankush Desai, MD DM

Phone

+91-9923486199

ankush_desai@rediffmail.com

First Name & Middle Initial & Last Name & Degree

Ankush Desai, MD DM

Facility Name

Department of Endocrinology, CARE Hospital,

City

Road No 1, Banjara Hills,

State/Province

Hyderabad,

ZIP/Postal Code

500 034

Country

India

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bipin Sethi, MD, DM

Phone

+919848021482

bipinkumarsethi@yahoo.co.uk

First Name & Middle Initial & Last Name & Degree

Bipin Sethi, MD, DM

Facility Name

Osmania General Hospital,

City

2nd Floor, Golden Jubilee Block, Afzalgunj,

State/Province

Hyderabad

ZIP/Postal Code

500012

Country

India

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rakesh Sahay, MD DM

Phone

+919849597507

sahayrk@gmail.com

First Name & Middle Initial & Last Name & Degree

Rakesh Sahay, MD DM

Facility Name

Amrita Institute of Medical Sciences

City

Kochi

State/Province

Kerala

ZIP/Postal Code

682041

Country

India

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

A G Unnikrishnan, MD, DM

Phone

+91-4844001559

unnikrishnanag@aims.amrita.edu

First Name & Middle Initial & Last Name & Degree

A G Unnikrishnan, Md, DM

Facility Name

Topiwala National Medical College & BYL Nair Ch. Hospital,

City

Dr. A. L. Nair Road, Mumbai Central,

State/Province

Mumbai

ZIP/Postal Code

400 008

Country

India

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Premalata Varthakavi, MD, DM

Phone

+919224480560

premavar@hotmail.com

First Name & Middle Initial & Last Name & Degree

Premlatha Varthakavi, MD, DM

Facility Name

Department of CHS, The Aga Khan, University,

City

P.O. BOx. 3500 Stadium, Road,

State/Province

Karachi

ZIP/Postal Code

74800

Country

Pakistan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hassan Daudzai, MBBS

Phone

+92214930051

Ext

4919

hassan.daudzai@aku.edu

First Name & Middle Initial & Last Name & Degree

Abdul Jabbar, MD DM

12. IPD Sharing Statement

Citations:

PubMed Identifier

30923749

Citation

Singh K, Ali MK, Devarajan R, Shivashankar R, Kondal D, Ajay VS, Menon VU, Varthakavi PK, Viswanathan V, Dharmalingam M, Bantwal G, Sahay RK, Masood MQ, Khadgawat R, Desai A, Prabhakaran D, Narayan KMV, Phillips VL, Tandon N; CARRS Trial Group. Rationale and protocol for estimating the economic value of a multicomponent quality improvement strategy for diabetes care in South Asia. Glob Health Res Policy. 2019 Mar 18;4:7. doi: 10.1186/s41256-019-0099-x. eCollection 2019.

Results Reference

derived

PubMed Identifier

27398874

Citation

Ali MK, Singh K, Kondal D, Devarajan R, Patel SA, Shivashankar R, Ajay VS, Unnikrishnan AG, Menon VU, Varthakavi PK, Viswanathan V, Dharmalingam M, Bantwal G, Sahay RK, Masood MQ, Khadgawat R, Desai A, Sethi B, Prabhakaran D, Narayan KM, Tandon N; CARRS Trial Group. Effectiveness of a Multicomponent Quality Improvement Strategy to Improve Achievement of Diabetes Care Goals: A Randomized, Controlled Trial. Ann Intern Med. 2016 Sep 20;165(6):399-408. doi: 10.7326/M15-2807. Epub 2016 Jul 12. Erratum In: Ann Intern Med. 2017 Aug 15;167(4):292.

Results Reference

derived

PubMed Identifier

23084280

Citation

CARRS Trial Writing Group; Shah S, Singh K, Ali MK, Mohan V, Kadir MM, Unnikrishnan AG, Sahay RK, Varthakavi P, Dharmalingam M, Viswanathan V, Masood Q, Bantwal G, Khadgawat R, Desai A, Sethi BK, Shivashankar R, Ajay VS, Reddy KS, Narayan KM, Prabhakaran D, Tandon N. Improving diabetes care: multi-component cardiovascular disease risk reduction strategies for people with diabetes in South Asia--the CARRS multi-center translation trial. Diabetes Res Clin Pract. 2012 Nov;98(2):285-94. doi: 10.1016/j.diabres.2012.09.023. Epub 2012 Oct 22.

Results Reference

derived

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