NCT01212328

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,120

participants targeted

Target at P75+ for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Oct 2010

Longer than P75 for not_applicable type-2-diabetes-mellitus

Geographic Reach
2 countries

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2010

Completed
24 days until next milestone

First Posted

Study publicly available on registry

September 30, 2010

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

September 5, 2011

Status Verified

September 1, 2011

Enrollment Period

3.2 years

First QC Date

September 6, 2010

Last Update Submit

September 2, 2011

Conditions

Type 2 Diabetes MellitusHypertensionDyslipidaemia

Keywords

T2DMDecision support softwarecare coordinator

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

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

    42 months after randomization

  • 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

Study Arms (2)

Care coordinator + Decision Support Software

EXPERIMENTAL

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

Usual care

ACTIVE COMPARATOR

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

Interventions

Care Coordinator + Decision Support SoftwareOTHER

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.)

Care coordinator + Decision Support Software
Usual careOTHER

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.

Usual care

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Bangalore Endocrinology and Diabetes Research Centre,

#35, 5th Cross,Malleswaram Circle,, Bangalore, Karnataka, 560 003, India

RECRUITING

St. John's Medical College & Hospital,

Sarjapur Road, Koramangala,, Bangalore, 560 034, India

RECRUITING

Diabetes Research Centre & MV Hospital for Diabetes,

No 4 West Madha Church Street, Royapuram, Chennai, 600 013, India

RECRUITING

Endocrine Division, Department of Medicine, Goa Medical College,

Bambolim, Goa, 403202, India

NOT YET RECRUITING

Department of Endocrinology, CARE Hospital,

Road No 1, Banjara Hills,, Hyderabad,, 500 034, India

RECRUITING

Osmania General Hospital,

2nd Floor, Golden Jubilee Block, Afzalgunj,, Hyderabad, 500012, India

RECRUITING

Amrita Institute of Medical Sciences

Kochi, Kerala, 682041, India

RECRUITING

Topiwala National Medical College & BYL Nair Ch. Hospital,

Dr. A. L. Nair Road, Mumbai Central,, Mumbai, 400 008, India

RECRUITING

Public Health Foundation of India

New Delhi, National Capital Territory of Delhi, 110016, India

RECRUITING

Department of CHS, The Aga Khan, University,

P.O. BOx. 3500 Stadium, Road,, Karachi, 74800, Pakistan

RECRUITING

Related Publications (6)

  • Cashmore BA, Cooper TE, Evangelidis NM, Green SC, Lopez-Vargas P, Tunnicliffe DJ. Education programmes for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 Aug 22;8(8):CD007374. doi: 10.1002/14651858.CD007374.pub3.

    PMID: 39171639DERIVED

  • Singh K, Kondal D, Jagannathan R, Ali MK, Prabhakaran D, Narayan KMV, Anand S, Tandon N; CARRS Trial Investigators. Rate and risk factors of kidney function decline among South Asians with type 2 diabetes: analysis of the CARRS Trial. BMJ Open Diabetes Res Care. 2024 Aug 16;12(4):e004218. doi: 10.1136/bmjdrc-2024-004218.

    PMID: 39153754DERIVED

  • Ali MK, Singh K, Kondal D, Devarajan R, Patel SA, Menon VU, Varthakavi PK, Vishwanathan V, Dharmalingam M, Bantwal G, Sahay RK, Masood MQ, Khadgawat R, Desai A, Prabhakaran D, Narayan KMV, Tandon N. Effect of a multicomponent quality improvement strategy on sustained achievement of diabetes care goals and macrovascular and microvascular complications in South Asia at 6.5 years follow-up: Post hoc analyses of the CARRS randomized clinical trial. PLoS Med. 2024 Jun 3;21(6):e1004335. doi: 10.1371/journal.pmed.1004335. eCollection 2024 Jun.

    PMID: 38829880DERIVED

  • 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.

    PMID: 30923749DERIVED

  • 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.

    PMID: 27398874DERIVED

  • 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.

    PMID: 23084280DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2HypertensionDyslipidemias

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesLipid Metabolism Disorders

Study Officials

  • Dorairaj Prabhakaran, MD, DM, MSc.

    Public Health Foundation of India

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kavita Singh, MSc.

CONTACT

+91-11-26850118kavita@ccdcindia.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2010

First Posted

September 30, 2010

Study Start

October 1, 2010

Primary Completion

December 1, 2013

Study Completion

June 1, 2014

Last Updated

September 5, 2011

Record last verified: 2011-09

Locations

IN(9)PA(1)