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

Registration

Registration

NCT03549754

Acronym

iCaReMe

Study type

OBSERVATIONAL

Status

RECRUITING

Enrollment

35000

Start

2018-02-17

Primary completion

2030-12-31

Lead sponsor

AstraZeneca

Conditions

Type 2 Diabetes; Hypertension; Chronic Kidney Disease; Heart Failure

Results posted

FALSE

Individual participant data sharing

YES

Registered primary outcomes

• 1. Age of particpants [At Baseline]
• 2. Percentage of Participants by Sex [At baseline]
• 3. Percentage of Participants by Ethnicity [At Baseline]
• 4. Percentage of Participants by Education Level [At Baseline]
• 5. Percentage of Participants by Marital Status [At Baseline]
• 6. Percentage of Participants with Family History of Cardiovascular and Renal-Metabolic Disease [At Baseline]
• 7.Percentage of Participants by Physical Activity Level [At Baseline]
• 8. Percentage of Participants by Smoking Status [At Baseline]
• 9. Percentage of Participants by Alcohol Consumption [At Baseline]
• 10. Body Weight of Participants [At Baseline]
• 11. Height of Participants [At Baseline]
• 12. Body Mass Index (BMI) of Participants [At Baseline]
• 13. Waist Circumference of Participants [At Baseline]
• 14. Waist-to-Hip Ratio of Participants [At Baseline]
• 15. Waist-to-Height Ratio of Participants [At Baseline]
• 16. Percentage of Participants by Cardiac and Renal Functional Measurements Category [At Baseline]
• 17. Primary Disease Duration [At Baseline]
• 18. Percentage of Participants by Number and Types of Comorbidities [At Baseline]
• 19. Percentage of Participants by NYHA Functional Class [At Baseline]
• 20. Percentage of Participants by Heart Failure Phenotype [At Baseline]
• 21. Percentage of Participants by Heart Failure Etiology [At Baseline]
• 22. Percentage of Participants by CKD Etiology [At Baseline]
• 23. Percentage of Participants by Hypertension Stage [At Baseline]
• 24. Percentage of Participants by Secondary Hypertension Etiology [At Baseline]
• 25. Office Systolic and Diastolic Blood Pressure [At Baseline]
• 26. Home Blood Pressure Monitoring (HBPM) Systolic and Diastolic Values [At Baseline]
• 27. Ambulatory Blood Pressure Monitoring (ABPM) Systolic and Diastolic Values [At Baseline]
• 28. Blood HbA1c [Average of 3 years]
• 29. Fasting Glucose [Average of 3 years]
• 30. Lipid Profile Testing [Average of 3 years]
• 31. Serum Creatinine [Average of 3 years]
• 32. Estimated Glomerular Filtration Rate (eGFR) [Average of 3 years]
• 33. Urine Albumin-to-Creatinine Ratio (UACR) [Average of 3 years]
• 34. Serum Electrolyte Values [Avergae of 3 years]
• 35. Frequency of HbA1c Testing [Average of 3 years]
• 36. Frequency of Fasting Glucose Testing [Average of 3 years]
• 37. Frequency of Lipid Profile Testing [Average of 3 years]
• 38. Frequency of Serum Creatinine Testing [Average of 3 years]
• 39. Frequency of eGFR Assessment [Average of 3 years]
• 40. Frequency of Urine Albumin-to-Creatinine Ratio Testing [Average of 3 years]
• 41. Echocardiography [Average of 3 years]
• 42. Electrocardiogram (ECG) [Average of 3 years]
• 43. Participants Receiving Dietary Modification Counseling [Average of 3 years]
• 44. Participants Enrolled in Exercise Programs [Average of 3 years]
• 45. Participants Receiving Weight Management Interventions [Average of 3 years]
• 46. Participants Receiving Smoking Cessation Counseling [Average of 3 years]
• 47. Participants Receiving Alcohol Reduction Counseling [Average of 3 years]
• 48. Percentage of Participants by Line of Treatment [Average of 3 years]
• 49. Percentage of Participants by Drug Class [Average of 3 years]
• 50. Percentage of Participants Undergoing Cardiac Surgeries (CABG or PCI) [Average of 3 years]
• 51. Percentage of Participants Receiving Dialysis [Average of 3 years]
• 52. Percentage of Participants with Cardiac Device Implantation [Average of 3 years]
• 53. Mean Duration of Pharmacological Treatments [Average of 3 years]
• 54. Drug Dose of Pharmacological Treatments [Average of 3 years]
• 55. Number of Primary Care Visits per Participant [Average of 3 years]
• 56. Number of Tertiary Care Hospital Visits per Participant [Average of 3 years]
• 57. Number of Specialist Care Visits per Participant [Average of 3 years]
• 58.Number of Emergency Department Visits per Participant [Average of 3 years]
• 59. All-Cause Hospitalizations [Average of 3 years]
• 60. Disease-Specific Hospitalizations [Average of 3 years]
• 61. All-Cause Emergency Department Visits [Average of 3 years]
• 62. Disease-Specific Emergency Department Visits [Average of 3 years]
• 63. Length of Hospital Stay [Average of 3 years]