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Type 2 Diabetes MellitusCARRSNCT01212328

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

A study testing Care Coordinator + Decision Support Software in people with Type 2 Diabetes Mellitus and Hypertension, run by Public Health Foundation of India at 10 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 35 years and older
What is being tested?
Care Coordinator + Decision Support Software
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,120 participants
Where
10 sitesin 2 countries
Study dates
Oct 2010to Jun 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 18Show fewer
  • 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

Trial locations and contacts

10 sites in 2 countries.

Kavita Singh, MSc. contact

+91-11-26850118 ext. 39

kavita@ccdcindia.org

10 sites in 2 countries

India9 sites, 9 recruiting

  • Bangalore Endocrinology and Diabetes Research Centre,

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

    Mala Dharmalingam, MD DM, +919845208163, drmala@bedrc.com

    Mala Dharamalingam, MD DM

    Recruiting

  • Osmania General Hospital,

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

    Rakesh Sahay, MD DM, +919849597507, sahayrk@gmail.com

    Rakesh Sahay, MD DM

    Recruiting

  • Endocrine Division, Department of Medicine, Goa Medical College,

    Bambolim, Goa, 403202

    Ankush Desai, MD DM, +91-9923486199, ankush_desai@rediffmail.com

    Ankush Desai, MD DM

    Not yet recruiting

  • Topiwala National Medical College & BYL Nair Ch. Hospital,

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

    Premalata Varthakavi, MD, DM, +919224480560, premavar@hotmail.com

    Premlatha Varthakavi, MD, DM

    Recruiting

  • Amrita Institute of Medical Sciences

    Kochi, Kerala, 682041

    A G Unnikrishnan, MD, DM, +91-4844001559, unnikrishnanag@aims.amrita.edu

    A G Unnikrishnan, Md, DM

    Recruiting

  • Public Health Foundation of India

    New Delhi, National Capital Territory of Delhi, 110016

    Dorairaj Prabhakaran, MD, DM, MSc., +91-11-26850588, dprabhakaran@ccdcindia.org

    Nikhil Tandon, MD, PhD

    Recruiting

  • Diabetes Research Centre & MV Hospital for Diabetes,

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

    Vijay Viswanathan, MD DM, +919840055535, dr_vijay@vsnl.com

    Vijay Vishwanatha, MD DM

    Recruiting

  • Department of Endocrinology, CARE Hospital,

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

    Bipin Sethi, MD, DM, +919848021482, bipinkumarsethi@yahoo.co.uk

    Bipin Sethi, MD, DM

    Recruiting

  • St. John's Medical College & Hospital,

    Sarjapur Road, Koramangala,, Bangalore, 560 034

    Ganapathy Bantwal, MD DM, +919448067318, mallyaganapathi@rediffmail.com

    Ganapathy Bantwal, MD DM

    Recruiting

Other trials in India

Pakistan1 site, 1 recruiting

  • Department of CHS, The Aga Khan, University,

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

    Hassan Daudzai, MBBS, +92214930051 ext. 4919, hassan.daudzai@aku.edu

    Abdul Jabbar, MD DM

    Recruiting

Other trials in Pakistan

About this study

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

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.

Being tested
Care Coordinator + Decision Support Software, Usual care
Keywords
T2DM, Decision support software, care coordinator
Medical subject headings
Diabetes Mellitus, Type 2, Hypertension, Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.)

  • 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.

Study groups in NCT01212328
Study groupRoleWhat they receive
Care coordinator + Decision Support SoftwareExperimentalCare 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.)
Receives: Other: Care Coordinator + Decision Support Software
Usual careActive comparatorUsual care (Active Comparator Arm): Patients will continue with the usual diabetes care with no care coordinator assistance and no decision support software - management prompt.
Receives: Other: Usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 42 months after randomization

Secondary outcomes (4)

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

    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)

    Measured: 42 months after randomization

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

    Measured: 42 months after randomization

  3. Quality of life

    Measured: 42 months after randomization

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

    Measured: 42 months after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionDec 2013 (estimated)
  4. Study completionJun 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01212328
Sponsor's protocol ID
UTRN 022342347-29072010248
Acronym
CARRS
Status last verified
Sep 2011
First submitted
6 Sep 2010
Last updated
5 Sep 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 39171639

  • 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.

    PubMed 39153754

  • 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.

    PubMed 38829880

  • 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.

    PubMed 30923749

  • 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.

    PubMed 27398874

  • 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.

    PubMed 23084280

Questions about this trial

What is this clinical trial studying?

A study testing Care Coordinator + Decision Support Software in people with Type 2 Diabetes Mellitus and Hypertension, run by Public Health Foundation of India at 10 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in India, Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Kavita Singh, MSc. (+91-11-26850118 ext. 39, kavita@ccdcindia.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Multiple CVD risk factor control targets (time frame: 42 months after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01212328, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2011.

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