Concept Elicitation and Patient Experience Mapping in SA-AKI

NCT ID: NCT07180238

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 28 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2025-09-30

Brief 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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

Potential participants who were diagnosed with SA-AKI (KDIGO stage I, II or III) must meet the following eligibility criteria:

• ≥18 to ≤ 85 years of age
• First diagnosis of SA-AKI at least 6 months prior to screening date, but no more than 10 years
• Admitted due to sepsis and/or AKI to intensive care unit (ICU), intermediate care unit (IMCU), or high-dependency care unit, or developed sepsis and/or AKI during their inpatient hospital stay.
• Resident of country of study (US or Germany)
• Access to computer, tablet, or smartphone with internet connection
• Willing to participate in an audio recorded interview

Participants will be required to present confirmation of diagnosis (COD) rather than relying on a self-reported diagnosis. Sepsis and AKI diagnoses will be confirmed through one of the following:

• Copy of medical records (e.g., portable document format [PDF] file of electronic health record)
• Physician confirmation of diagnosis of sepsis and AKI (post-sepsis)

Potential caregiver participants must meet the following criteria:

• ≥18 to ≤ 85 years of age
• Primary caregiver/care-partner for eligible participant who experienced SA-AKI
• Resident of country of study (US or Germany)
• Access to computer, tablet, or smartphone with internet connection
• Willing to participate in an audio recorded interview

Exclusion Criteria

Potential participants are not eligible if they meet any of the following criteria:

• Less than age of majority in locality (Participant is not considered an adult in their country or region)
• Not willing to participate in an audio recorded interview
• Not able to participate in the interview or complete required study surveys, based on the discretion of the study team

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

East Hanover, New Jersey, United States

Countries

United States

Other Identifiers

CTIN816B12002

Identifier Type: -

Identifier Source: org_study_id