NCT07180238

Concept Elicitation and Patient Experience Mapping in SA-AKI

Concept Elicitation and Patient Experience Mapping in Sepsis-associated Acute Kidney Injury

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 28 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a concept elicitation study on patient's experiences of Sepsis-associated Acute Kidney Injury (SA-AKI)

Detailed description

The purpose of this study is to elicit concepts of interests in patients who experienced SA-AKI. The study also aims to map experiences from patient and caregiver perspectives, including treatment pathways and barriers to SA-AKI treatment, the burden of SA-AKI and unmet needs, and the disease's humanistic, societal, and economic impacts. This study is a cross-sectional, non-interventional qualitative interview study of up to 30 people who have experienced SA-AKI from the US and Germany. Participants will be screened for eligibility, provide consent, and complete a virtual, hybrid 60-minute semi-structured concept elicitation (CE) and patient experience interview. Transcripts will be reviewed by analysts and analysed according to a qualitative analysis plan including a thematic analysis of the coded transcripts. This is a minimal risk study. All information will be kept confidential, and information will be stored on a secure network which is only accessible to the study team.

Conditions

• Sepsis-associated Acute Kidney Injury

Timeline

• Start date: 2025-05-01
• Primary completion: 2025-09-30
• Completion: 2025-09-30
• First posted: 2025-09-18
• Last updated: 2025-12-12

Locations

1 site across 1 country: United States