Humanistic Burden of Rare Kidney Diseases: Understanding the Impact of FSGS and IgAN on Patients and Caregivers Study (HONUS) - A Multi-National, Cross-Sectional Survey Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 487
- 试验地点
- 1
- 主要终点
- Adult patient, adult patient care-partner and pediatric patient parent/care-partner anxiety.
研究概览
简要总结
The aim of this observational study is to assess humanistic burden among adults and children/adolescents with FSGS and IgAN as well as the burden and impact for patient care-partners in six countries (United States [US], United Kingdom [UK], France, Germany, Italy and Spain).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients and their adult care-partners: At least 18 years old; Either have a physician-provided diagnosis of FSGS or IgAN (with renal biopsy confirmation of the diagnosis) or being a care-partner for someone with a physician-provided diagnosis of FSGS or IgAN (with renal biopsy confirmation of the diagnosis);
- •Able to provide informed consent;
- •Located in the United States (US), United Kingdom (UK), Germany, France, Spain or Italy.
- •*Care-partners (paired with adult patients) (defined as the individual [e.g., spouse, parent, sibling, relative, or friend] providing direct disease-related support to the adult patient.
- •**All patient groups including chronic kidney disease (CKD) stage 1-5, with or without dialysis, and with or without kidney transplant will be included.
- •Care-partners/parents of children/adolescents: At least 18 years old;
- •Being a care-partner of children/adolescents with physician-provided diagnosis of FSGS or IgAN (with renal biopsy or genetic confirmation of the diagnosis);
- •Able to provide informed consent; Located in the US, UK, Germany, France, Spain or Italy.
- •Care-partners will be defined as family members who provide disease-related support and unpaid care to child/adolescent patients
排除标准
- •Patient has FSGS or IgAN secondary to another condition;
- •Patient has a history of malignancy other than adequately treated basal cell or squamous cell skin cancer;
- •Patient has a co-existing glomerular disease (e.g., membranous nephropathy, lupus nephritis);
- •Patient is currently participating in a kidney disease clinical trial, and potentially receiving active treatment as part of the trial.
结局指标
主要结局
Adult patient, adult patient care-partner and pediatric patient parent/care-partner anxiety.
时间窗: Day 1, day of enrollment
Measured by General Anxiety Disorder 7 (GAD-7) questionnaire.
Demographics
时间窗: Day 1, day of enrollment
Adult patients (self-reported) - age, sex, education level, household income, marital status, current work status, race/ethnicity (for patients in the US and in the UK), health insurance (for patients in the US), approximate travel time to receive FSGS/IgAN medical care. Child/adolescent patients (reported by parent/care-partner) - age, sex, current school status, race/ethnicity (for patients in the US and in the UK), approximate travel time to receive FSGS/IgAN medical care. Care-partners of adult patients and parents/care-partners of child/adolescent patients - age, sex, education level, household income, marital status, relationship to person with FSGS/IgAN, current work status, race/ethnicity (for patients in the US and UK).
Pediatric patient health-related quality of life (reported by parent/care-partner).
时间窗: Day 1, day of enrollment
Measured by Pediatric Quality of Life Inventory (PedsQL) Parent report for teens (ages 13-18) or Parent report for children (ages 8-12).
Adult patient cognition.
时间窗: Day 1, day of enrollment
Measured by cognition items of the Massachusetts General Hospital (MGH) Cognitive and Physical Functioning Questionnaire (CPFQ).
Disease history.
时间窗: Day 1, day of enrollment
Adult patients (self-reported) - length of time from onset of symptoms to diagnosis, time since diagnosis, renal biopsy status, comorbidities, CKD (Chronic kidney disease) stage at diagnosis, current CKD stage (including dialysis status), transplant status (including type of transplant and occurrence of rejection or recurrence of disease), current level of proteinuria. Pediatric/adolescent patients (reported by parent/care-partner) - length of time from onset of symptoms to diagnosis, time since diagnosis, renal biopsy status, comorbidities, CKD stage at diagnosis, current CKD stage (including dialysis status), transplant status (including type of transplant and occurrence of rejection or recurrence of disease), current level of proteinuria.
Adult patient health-related quality of life.
时间窗: Day 1, day of enrollment
Measured by Kidney Disease Quality of Life 36-item Short Form Survey (KDQOL-36).
Adult patient care-partner and pediatric patient parent/care-partner health-related quality of life.
时间窗: Day 1, day of enrollment
Measured by 12-Item Short Form Health Survey (SF-12).
Adult patient care-partner and pediatric patient parent/care-partner productivity impairment.
时间窗: Day 1, day of enrollment
Measured by Work Productivity and Activity Impairment Questionnaire (WPAI) caregiver version.
Adult patient, adult patient care-partner and pediatric patient parent/care-partner depression.
时间窗: Day 1, day of enrollment
Measured by Patient Health Questionnaire 9 (PHQ-9) module.
Pediatric patient symptoms (reported by parent/care-partner).
时间窗: Day 1, day of enrollment
Measured by 5-point Likert scale ranking of most burdensome symptoms.
Adult patient, pediatric patient (reported by parent/care-partner), adult patient care-partner and pediatric patient parent/care-partner fear and anxiety for the future.
时间窗: Day 1, day of enrollment
Measured by 5-point Likert scale fear and anxiety for the future.
Adult patient productivity impairment.
时间窗: Day 1, day of enrollment
Measured by Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP).
Pediatric/adolescent patient impact of disease (reported by parent/care-partner).
时间窗: Day 1, day of enrollment
Measured by 5-point Likert scale impact on patient education, career (adolescents), employment (adolescents), relationships and lifestyle.
Adult patient symptoms.
时间窗: Day 1, day of enrollment
Measured by 5-point Likert scale ranking of most burdensome symptoms.
Adult patient, adult patient care-partner and pediatric patient parent/care-partner impact of disease.
时间窗: Day 1, day of enrollment
Measured by and 5-point Likert scale impact on education, career, employment, relationships, personal finances and lifestyle.
次要结局
未报告次要终点