iCaReMe Global Registry (iCaReMe)

April 4, 2024 updated by: AstraZeneca

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

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

Study Overview

Status

Recruiting

Conditions

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

Enrollment (Estimated)

35000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Costa Rica
    • San José
      • Los Yoses, San José, Costa Rica, 11501
        • Completed
        • Research Site
  • Ecuador
    • Guayas
      • Guayaquil, Guayas, Ecuador, 090513
        • Not yet recruiting
        • Research Site
    • Manabi
      • Manta, Manabi, Ecuador, 130215
        • Not yet recruiting
        • Research Site
    • Pichincha
      • Quito, Pichincha, Ecuador, 170103
        • Not yet recruiting
        • Research Site
      • Quito, Pichincha, Ecuador, 170131
        • Not yet recruiting
        • Research Site
      • Quito, Pichincha, Ecuador, 170148
        • Not yet recruiting
        • Research Site
  • Egypt
    • Cairo
      • Al Kasr Al Eini, Cairo, Egypt, 11562
        • Completed
        • Research Site
      • El Matareya, Cairo, Egypt, 4540046
        • Not yet recruiting
        • Research Site
      • El Nozha, Cairo, Egypt, 11769
        • Completed
        • Research Site
      • Maadi, Cairo, Egypt, 11728
        • Completed
        • Research Site
      • Ramses, Cairo, Egypt, 11678
        • Recruiting
        • Research Site
      • Roxy, Cairo, Egypt, 11864
        • Completed
        • Research Site
    • Giza
      • Agouza, Giza, Egypt, 12654
        • Recruiting
        • Research Site
      • Faisal, Giza, Egypt, 21634
        • Completed
        • Research Site
  • Ghana
    • Ashanti Region
      • Kumasi, Ashanti Region, Ghana, 233
        • Recruiting
        • Research Site
  • Greece
      • Lamia, Greece, 35100
        • Active, not recruiting
        • Research Site
      • Larissa, Greece, 41110
        • Active, not recruiting
        • Research Site
      • Thessaloniki, Greece, 54645
        • Active, not recruiting
        • Research Site
      • Thessaloniki, Greece, 54621
        • Active, not recruiting
        • Research Site
      • Thessaloniki, Greece, 54635
        • Active, not recruiting
        • Research Site
    • Athens
      • Attica, Athens, Greece, 17562
        • Active, not recruiting
        • Research Site
      • Attiki, Athens, Greece, 11526
        • Active, not recruiting
        • Research Site
      • Attiki, Athens, Greece, 15123
        • Active, not recruiting
        • Research Site
      • Attiki, Athens, Greece, 18547
        • Active, not recruiting
        • Research Site
      • Attiki, Athens, Greece
        • Active, not recruiting
        • Research Site
    • Nea Moudania
      • Chalkidiki, Nea Moudania, Greece, 63200
        • Active, not recruiting
        • Research Site
    • Piraeus
      • Attiki, Piraeus, Greece, 18536
        • Active, not recruiting
        • Research Site
  • India
    • Ahmedabad
      • Gujarat, Ahmedabad, India, 380015
        • Completed
        • Research Site
  • Indonesia
    • Telanaipura
      • Jambi, Telanaipura, Indonesia, 36111
        • Completed
        • Research Site
  • Kenya
      • Eldoret, Kenya, 30100
        • Recruiting
        • Research Site
  • Mexico
      • Chihuahua, Mexico, 31217
        • Completed
        • Research Site
    • Guadalajara
      • Jalisco, Guadalajara, Mexico, 44280
        • Completed
        • Research Site
      • Jalisco, Guadalajara, Mexico, 44340
        • Completed
        • Research Site
      • Jalisco, Guadalajara, Mexico, 44530
        • Completed
        • Research Site
      • Jalisco, Guadalajara, Mexico, 44600
        • Completed
        • Research Site
      • Jalisco, Guadalajara, Mexico, 44670
        • Completed
        • Research Site
      • Jalisco, Guadalajara, Mexico, 45510
        • Completed
        • Research Site
    • Guadalupe
      • Nuevo Leon, Guadalupe, Mexico, 67144
        • Completed
        • Research Site
    • Monterrey
      • Nuevo Leon, Monterrey, Mexico, 67150
        • Completed
        • Research Site
    • San Juan Del Río
      • Queretaro, San Juan Del Río, Mexico, 76800
        • Completed
        • Research Site
    • San Nicolás De Los Garza
      • Nuevo Leon, San Nicolás De Los Garza, Mexico, 66603
        • Completed
        • Research Site
  • Nigeria
      • Lagos, Nigeria, 234
        • Recruiting
        • Research Site
  • Peru
      • Lima, Peru, 15033
        • Not yet recruiting
        • Research Site
      • Lima, Peru, 15072
        • Not yet recruiting
        • Research Site
      • Lima, Peru, 15082
        • Not yet recruiting
        • Research Site
      • Lima, Peru, 15102
        • Not yet recruiting
        • Research Site
  • Philippines
      • Cebu, Philippines, 600
        • Recruiting
        • Research Site
      • Iloilo, Philippines, 500
        • Recruiting
        • Research Site
    • Cavite
      • Dasmarinas, Cavite, Philippines, 4114
        • Recruiting
        • Research Site
    • Metro Manila
      • Marikina, Metro Manila, Philippines, 1810
        • Recruiting
        • Research Site
      • Pasig, Metro Manila, Philippines, 1605
        • Recruiting
        • Research Site
    • Rizal
      • Antipolo, Rizal, Philippines, 1870
        • Recruiting
        • Research Site
  • South Africa
    • Johannesburg
      • Benoni, Johannesburg, South Africa, 1501
        • Recruiting
        • Research Site
    • KwaZulu Natal
      • Durban, KwaZulu Natal, South Africa, 4319
        • Recruiting
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults with type 2 diabetes, Hypertension, Heart Failure and/or chronic kidney disease

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Average of 3 years through study completion
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
Average of 3 years through study completion
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
Average of 3 years through study completion
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
Average of 3 years through study completion
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
Average of 3 years through study completion
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
Average of 3 years through study completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2018

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

May 15, 2018

First Submitted That Met QC Criteria

May 29, 2018

First Posted (Actual)

June 8, 2018

Study Record Updates

Last Update Posted (Actual)

April 5, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1690R00044

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing 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.

IPD Sharing 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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