Real world data on patient management and quality of care

Recruiting

• Conditions: Heart failure, unspecified, (2) ICD-10 Condition: N189||Chronic kidney disease, unspecified, (3) ICD-10 Condition: E11||Type 2 diabetes mellitus,

• Registration Number: CTRI/2021/11/038338
• Lead Sponsor: AstraZeneca Pharma India Ltd

Brief Summary

This study is to provide real world data on patient characteristics, disease management, healthcare utilization, and outcomes in patients with type 2 diabetes, Heart Failure and Chronic Kidney Disease

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-12
• Last Update Posted: 2022-01-04

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 8500

Inclusion Criteria

• ≥18 years old 2.
• Having type 2 diabetes, CKD and/or HF 3.
• Providing written informed consent to participate in the study.

Exclusion Criteria

• Having any life-threatening co-morbidity and a life expectancy of less than 1 year 2.
• Participating in any interventional trial requiring informed consent.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
3. Truly global data capture	12 months
1. Data on real-world management of either/or cardiovascular diseases, T2DM and/or CKD	12 months
4. Quality KPIs for benchmarking and improving quality of care	12 months
2. Long-term data collection	12 months

Secondary Outcome Measures

Name	Time	Method
To determine risk factors associated with progression of microvascular and macrovascular disease complications, patient outcomes, loss of quality of life, and increased healthcare resource utilization during follow-up	12 Months

Trial Locations

Locations (1)

AMRI Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

AMRI Hospital

🇮🇳Kolkata, WEST BENGAL, India

Dr Ranjan Sarkar

Principal investigator

9830020762

ranjansarkar1964@hotmail.com