We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

iCaReMe Global Registry (iCaReMe)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03549754
Recruitment Status : Recruiting
First Posted : June 8, 2018
Last Update Posted : January 11, 2023
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date May 15, 2018
First Posted Date June 8, 2018
Last Update Posted Date January 11, 2023
Actual Study Start Date February 17, 2018
Estimated Primary Completion Date December 31, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 22, 2021)
  • 1. Provide real world data on patient characteristics [ Time Frame: Average of 3 years through study completion ]
    Disease control (e.g. achievement of glycated hemoglobin target and incidence of hypoglycemic events) Management of micro- and/or macrovascular complications Management of associated risk factors (e.g. hypercholesterolemia and hypertension) Current diabetes, CKD and HF treatments Concomitant medications
  • 2. Provide real world data on disease management [ Time Frame: Average of 3 years through study completion ]
    Disease control (e.g. achievement of glycated hemoglobin target and incidence of hypoglycemic events) Management of micro- and/or macrovascular complications Management of associated risk factors (e.g. hypercholesterolemia and hypertension) Current diabetes treatments Concomitant medications
  • 3. Provide real world data on healthcare utilization [ Time Frame: Average of 3 years through study completion ]
    Number of diabetes, Chronic Kidney Disease(CKD) and Heart Failure(HF)-related visits to a physician not at study site Number of urgent care visits for diabetes Number of diabetes, CKD and HF-related hospital emergency department visits and reason(s) for visits Number of hospitalizations, lengths of stay, and reasons for hospitalizations
  • 4. Provide real world data on quality of care indicators [ Time Frame: Average of 3 years through study completion ]
    Smoking cessation Eye and foot examinations Dietary counselling
  • Provide real world data on cardiovascular outcomes in patients with type 2 diabetes; Chronic Kidney Disease and Heart Failure [ Time Frame: Average of 3 years through study completion ]
    All-cause and cause-specific deaths and hospitalizations, including recurrent events
  • 6. Provide real world data on renal outcomes and other microvascular complications in patients with type 2 diabetes and Heart Failure [ Time Frame: Average of 3 years through study completion ]
    All-cause and cause-specific deaths and hospitalizations, including recurrent events
Original Primary Outcome Measures
 (submitted: May 29, 2018)
  • Provide real world data on patient characteristics. [ Time Frame: Average of 3 years through study completion ]
    Patient demography Patient height & weight, blood pressure Diabetes and general medical history Laboratory test results
  • Provide real world data on disease management. [ Time Frame: Average of 3 years through study completion ]
    Disease control (e.g. achievement of glycated hemoglobin target and incidence of hypoglycemic events) Management of micro- and/or macrovascular complications Management of associated risk factors (e.g. hypercholesterolemia and hypertension) Current diabetes treatments Concomitant medications
  • Provide real world data on healthcare utilization. [ Time Frame: Average of 3 years through study completion ]
    Number of diabetes-related visits to a physician not at study site Number of urgent care visits for diabetes Number of diabetes-related hospital emergency department visits and reason(s) for visits Number of hospitalizations, lengths of stay, and reasons for hospitalizations
  • Provide real world data on quality of care indicators. [ Time Frame: Average of 3 years through study completion ]
    Smoking cessation Eye and foot examinations Dietary counselling
  • Provide real world data on cardiovascular outcomes in patients with type 2 diabetes. [ Time Frame: Average of 3 years through study completion ]
    All-cause and cause-specific deaths and hospitalizations, including recurrent events
  • Provide real world data on renal outcomes and other microvascular complications in patients with type 2 diabetes [ Time Frame: Average of 3 years through study completion ]
    All-cause and cause-specific deaths and hospitalizations, including recurrent events
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title iCaReMe Global Registry
Official Title Real-world Multinational Registry to Determine Management and Quality of Care of Patients With Type 2 Diabetes, Hypertension, Heart Failure and/or Chronic Kidney Diseases
Brief Summary To provide real world data on patient characteristics, disease management, healthcare utilization, and outcomes in patients with type 2 diabetes, Hypertension, Heart failure and/or Chronic kidney diseases
Detailed Description The registry intends to provide real world data on patient management and quality of care for patients with T2DM, hypertension, heat failure and chronic kidney disease in clinical practice in many countries. To bridge this gap an observational voluntary registry is set up to capture real world data on patient characteristics, disease management, healthcare utilization, and outcomes in patients with type 2 diabetes, Hypertension, Heart Failure and Chronic Kidney Disease. Multinational, observational registry utilizing a cloud-based eCRF, for prospective and retrospective data collection, accessible to investigators and Scientific Committee. This registry will be open to all physicians managing T2DM, HTN, HF or CKD across the world.
Study Type Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration 3 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adults with type 2 diabetes, Hypertension, Heart Failure and/or chronic kidney disease
Condition
  • Type 2 Diabetes
  • Hypertension
  • Chronic Kidney Disease
  • Heart Failure
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 28, 2022)
35000
Original Estimated Enrollment
 (submitted: May 29, 2018)
20000
Estimated Study Completion Date December 31, 2025
Estimated Primary Completion Date December 31, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Being 18 years or older
  2. Having type 2 diabetes, Hypertension, Heart Failure and/or chronic kidney disease
  3. Providing written informed consent to participate in the registry

Exclusion Criteria:

  1. Having a life-threatening co-morbidity with life expectancy below 1 year
  2. Participating in an interventional trial requiring informed consent
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com
Listed Location Countries Costa Rica,   Egypt,   India,   Malaysia,   Mexico
Removed Location Countries Angola,   Argentina,   Brazil,   Canada,   China,   Ethiopia,   Georgia,   Ghana,   Greece,   Guatemala,   Hong Kong,   Indonesia,   Kenya,   Korea, Republic of,   Lebanon,   Oman,   Philippines,   Qatar,   Russian Federation,   Saudi Arabia,   Thailand,   Uganda,   Ukraine
 
Administrative Information
NCT Number NCT03549754
Other Study ID Numbers D1690R00044
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description:

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home
Current Responsible Party AstraZeneca
Original Responsible Party Same as current
Current Study Sponsor AstraZeneca
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account AstraZeneca
Verification Date December 2022