Concept Elicitation and Patient Experience Mapping in Sepsis-associated Acute Kidney Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Patient perspective on sign, symptoms and impacts of SA-AKI
研究概览
简要总结
This is a concept elicitation study on patient's experiences of Sepsis-associated Acute Kidney Injury (SA-AKI)
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Patient perspective on sign, symptoms and impacts of SA-AKI
时间窗: 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
次要结局
- 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)