| CTRI Number |
CTRI/2010/091/001185 [Registered on: 08/09/2010] |
| Last Modified On: |
22/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
A multi-site, individually randomized, controlled translation trial of integrated and comprehensive care strategies to reduce CVD risk among 1,120 T2DM patients in South Asia. |
Scientific Title of Study
Modification(s)
|
Developing and Testing Integrated, Multi-factorial Cardiovascular Disease Risk Reduction Strategies in South Asia (CARRS Translation Trial) |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| HHSN268200900026C |
Other |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dorairaj Prabhakaran |
| Designation |
|
| Affiliation |
|
| Address |
Centre for Chronic Disease Control
Tower No. 4, C-9, Commercial Complex, (Near Bloom School)
Vasant Kunj, New Delhi-110070
New Delhi
DELHI
110070
India |
| Phone |
011-43421900 |
| Fax |
011-43421975 |
| Email |
dprabhakaran@ccdcindia.org |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Nikhil Tandon |
| Designation |
|
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Centre for Chronic Disease Control
Tower No. 4, C-9, Commercial Complex, (Near Bloom School)
Vasant Kunj, New Delhi-110070
New Delhi
DELHI
110070
India |
| Phone |
011-43421900 |
| Fax |
011-43421975 |
| Email |
nikhil_tandon@hotmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Kavita Singh |
| Designation |
|
| Affiliation |
|
| Address |
Centre for Chronic Disease Control
Tower No. 4, C-9, Commercial Complex, (Near Bloom School)
Vasant Kunj, New Delhi-110070
New Delhi
DELHI
110070
India |
| Phone |
011-43421900 |
| Fax |
011-43421975 |
| Email |
kavita@ccdcindia.org |
|
Source of Monetary or Material Support
Modification(s)
|
| National Heart Lung and Blood Institute, National Instutes of Health, USA and United Health Group |
|
Primary Sponsor
Modification(s)
|
| Name |
National Heart Lung and Blood Institute National Institutes for Heath USA |
| Address |
NHLBI Health Information Center
P.O. Box 30105
Bethesda, MD 20824-0105 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Ovations, United Health Group
Contact Person: Richard Smith,
Director of United Health Chronic Disease Initiative, London, UK
email id: richardswsmith@yahoo.co.uk |
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Nikhil Tandon |
All India Institute of Medical Sciences |
Department of Endocrinology,Ansari Nagar-110029
New Delhi
DELHI |
91-11-6593237
91-11-6862663
nikhil_tandon@hotmail.com |
| Dr. AG Unnikrishnan |
Amrita Institute of Medical Sciences |
Department of Endocrinology & Diabetes ,Ponekkara Post-682041
|
09846005343
unnikrishnanag@aims.amrita.edu |
| Dr. Mala Dharmalingam |
Bangalore Endocrinology & Diabetes Research Centre |
#35, 5th Cross,Malleswaram Circle-560 003
Bangalore
KARNATAKA |
09845208163
mala_endo@rediffmail.com |
| Dr. Bipin Kumar Sethi |
CARE Hospital |
Department of Endocrinology,Road No 1, Banjara Hills-500 034
Hyderabad
ANDHRA PRADESH |
09848021482
bipinkumarsethi@yahoo.co.uk |
| Ankush Desai |
Goa Medical College |
Endocrine Division, Department of Medicine, Goa Medical College, Bambolim Goa 403202
South Goa
GOA |
9923486199
ankush_desai@rediffmail.com |
| Dr. R. Guha Pradeepa |
Madras Diabetes Research Foundation |
No.4 Conran Smith Road ,Gopalapuram -600 086
Chennai
TAMIL NADU |
044 28359048/8261
guhapradeepa@gmail.com |
| Dr. Vijay Viswanathan |
MV Hospital for Diabetes & Diabetes Research Centre |
No 4 West Madha Church Street ,Royapuram -600 013
Chennai
TAMIL NADU |
09840055535
dr_vijay@vsnl.com |
| Dr. Rakesh Sahay |
Osmania General Hospital |
2nd Floor, Golden Jubilee Block,Afzalgunj -500012
Hyderabad
ANDHRA PRADESH |
09849597507
sahayrk@gmail.com |
| Dr. Dorairaj Prabhakaran |
Public Health Foundation of India |
C1/52, Safdarjaung Development Area,Hauz Khas-110016
New Delhi
DELHI |
011 26850118
011 26850588
dprabhakaran@ccdcindia.org |
| Dr. Ganapathi Bantwal |
St. John's Medical College & Hospital |
Sarjapur Road,Koramangala-560 034
Bangalore
KARNATAKA |
09448067318
mallyaganapathi@rediffmail.com |
| Dr. Premlata Varthakavi |
TNM College & BYL Nair Ch. Hospital |
Topiwala National Medical College & BYL Nair Ch. Hospital, Dr. A. L. Nair Road,Dr. A. L. Nair Road, Mumbai Central-400 008
Mumbai
MAHARASHTRA |
09224480560
premavar@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 11 |
| Name of Committee |
Approval Status |
| Ethics Committee on Human Research, Bangalore Endocrinology & Diabetes Research Centre |
Approved |
| Ethics Committee, BYL Nair Ch. Hospital & T.N Medical College |
Approved |
| Ethics Committee, Osmania Medical College |
Approved |
| Institute Ethics Committee, AIIMS |
Approved |
| Institutional Ethical Review Board, St. Johns Medical College & Hospital |
Approved |
| Institutional Ethics Committee Goa Medical College |
Approved |
| Institutional Ethics Committee, Amrita Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee, CARE Foundation |
Approved |
| Institutional Ethics Committee, Diabetes Research Centre |
Approved |
| Madras Diabetes Research Foundation, Institutional Ethics Committee |
Approved |
| PHFI, Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
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| Health Type |
Condition |
| Patients |
Cardiometabolic diseases - Type 2 diabetes mellitus , (1) ICD-10 Condition: E115||Type 2 diabetes mellitus with circulatory complications, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Electronic Health Records- Decision Support Software (EHR-DSS); Non-Physician care coordinator; management guidelines |
Duration-3-3.5 years |
| Comparator Agent |
Usual Care |
Usual Care |
|
Inclusion Criteria
Modification(s)
|
| Age From |
35.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
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 greater than or equal to 8.0%) AND one or both of: dyslipidemia (LDL greater than or equal to 130 mg/dl) or systolic hypertension (SBP greater than or equal to 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 investigators assessment the patient is likely to follow-up regularly as required by the protocol.
5. Willingness to consent to randomization
Note- The trial has no upper age limit.
|
|
| ExclusionCriteria |
| Details |
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 CHF or 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], TB patient on treatment, psychiatric illness or cognitive impairment, alcohol or drug abuse, history of organ transplant, 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 |
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| The study has one primary outcome of interest, multiple CVD risk factor control targets: at least two targets including HbA1c 7.0% and at least one of: BP 130/80 mmHg or LDL-cholesterol 100 mg/dl (LDL cholesterol 70 mg/dl for those with history of CVD event). |
Baseline, 3 monthly (for intervention arm only), Annually & End of Study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| (1) Single risk factor control targets, as demonstrated by:
(a) at least an absolute 10% point greater proportion of participants in the intervention group achieving good glycemic control (HbA1c < 7%);
(b) at least an absolute 10% point greater proportion of participants in the intervention group achieving blood pressure control (systolic BP < 130 and diastolic BP < 80 mmHg); and
(c) at least an absolute10% point greater proportion of participants in the intervention group achieving lipid control (LDL-cholesterol < 100 mg/dl; < 70 mg/dl for those with history of CVD event)
(2) Quality of care measures, as demonstrated by participant and provider adherence to:
(a) currently advocated CVD risk factor management guidelines (i.e. proportion of patients prescribed and/or using lipid-or BP-lowering medication, where indicated; proportion of participants smoking who have stopped; proportion of patients who were given lifestyle modification advice and/or adhering to dietary and physical activity targets) and
(b) evidence-based processes of care (i.e. use of aspirin and/or RAS-modifiers; and annual eye, foot, dental and urine examinations);
(c) Assessment methods:
i. Participant Perspective (Self-management):Summary of Diabetes Self-Care Activities (SDSCA)
ii. Provider Perspective: Electronic Health Records from DSS (Documentation by Care Coordinator and Research Officer)
(3) Patient-related outcomes of:
(a) Participant health-related quality of life (QoL)
i. Event-related: European Quality of Life 5 Dimensions (EQ-5D)
ii. General: Health Utility Index (HUI-3)
(b) Treatment satisfaction
i. Diabetes Treatment Satisfaction Questionnaire (DTSQ)
(4) To evaluate the sustainability of the intervention using the following methods:
(a) Cost-effectiveness of the intervention by assessing the incremental costs and benefits of the intervention versus standard care for the clinic facility.
i. Questionnaire: Frequency/Costs of Care
ii. Electronic health records of DSS; Clinical Administration System
(b) Qualitative assessments of acceptability and sustainability of the intervention through interviews of a subsample of intervention participants and site physicians for quality assurance. Patients who drop out of the study will be followed up by a Research Coordinating Centre staff to explore reasons for discontinuing involvement.
|
Baseline, Annually & End of the Study |
|
Target Sample Size
Modification(s)
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Total Sample Size="1146"
Sample Size from India="1006"
Final Enrollment numbers achieved (Total)= "1146"
Final Enrollment numbers achieved (India)="1146" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
31/10/2019 |
| Date of First Enrollment (Global) |
15/09/2010 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
1. 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.
2. 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 Jul 12. doi: 10.7326/M15-2807.
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Background: Cardiovascular diseases 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. Eligibility criteria for entry into the study include all the following: 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 (2006 WHO criteria, 154) 3. Poor glycemic control (as evidenced by HbA1c >= 8.0%) AND one or both of: dyslipidemia (LDL 130 >= mg/dl) or systolic hypertension (SBP >= 140 mmHg), irrespective of lipid or BP lowering medication use, respectively 4. Receiving diabetes care in the same clinic for at least 6 months with at least 2 documented visits at this clinic 5. Willingness to consent to randomization |