Sepsis-associated Acute Kidney Injury
Conditions
Keywords
Sepsis, Acute Kidney Injury
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.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient perspective on sign, symptoms and impacts of SA-AKI | Up to 3 months | A 60-min qualitative interview will be conducted and transcripts will be coded to assess which signs, symptoms and impacts of SA-AKI have been experienced by the participant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient experiences on treatment pathways and barriers to SA-AKI treatment, the burden of SA-AKI and unmet needs, and the humanistic, societal, and economic impacts | Up to 3 months | A 60-min qualitative interview will be conducted and transripts will be coded to assess the treatment pathways and barriers to SA-AKI treatment, the burden of SA-AKI and unmet needs, and the humanistic, societal, and economic impacts |
Countries
United States
Outcome results
None listed