A Prospective, Non-interventional Study Measuring Quality of Life, Treatment Preference and Treatment Satisfaction of Autosomal Dominant Polycystic Kidney Disease Patients in Europe
试验速览
- 阶段
- 不适用
- 入组人数
- 407
- 试验地点
- 26
- 主要终点
- Mean rate of change (%) in Physical Health Composite Scale (PCS) scores of the 12-Item Short Form Survey (SF-12)
研究概览
简要总结
This is a prospective, non-interventional study (NIS) measuring health-related quality of life (HRQoL), treatment satisfaction, and other patient-reported outcomes (PROs) of ADPKD patients in Europe.
详细描述
This is a prospective, non-interventional study (NIS) measuring HRQoL, treatment satisfaction, and other PROs of ADPKD patients in Europe. The study aims to enrol at least 486 patients. Data will be prospectively collected at clinics, from medical notes and via PRO measures for each patient at Baseline, Month 1, Month 3 and subsequently at 3 month intervals up to and including the final assessment (18 months maximum follow-up time). No visits with the patients' treating physician will be imposed by the protocol. Any clinical visits will occur as per normal clinical practice
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Male and female aged ≥ 18 years.
- •Patient has a diagnosis of ADPKD between CKD Stages 1-3, and is deemed by their treating physician to likely have rapidly progressing disease.
- •Patient has a life expectancy greater than 18 months at time of enrolment.
- •Patient is able and willing to give informed consent, if required according to local regulations.
- •Patient is fluent in local language.
排除标准
- •Patient is currently participating in, or has in the last 12 months participated in an interventional clinical trial.
- •Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient.
- •Inability of the patient to complete PROs remotely.
结局指标
主要结局
Mean rate of change (%) in Physical Health Composite Scale (PCS) scores of the 12-Item Short Form Survey (SF-12)
时间窗: From Baseline to end of study (maximum of 18 months)
Mean rate of change (%) in Physical Health Composite Scale (PCS) scores of the SF-12 from baseline to end of study, in the overall sample and per chronic kidney disease (CKD) stage.
次要结局
- Mean Treatment Satisfaction Questionnaire for Medication (TSQM-9) score changes(From Baseline to end of study (maximum of 18 months))
- Mean ADPKD-IS score changes(From Baseline to end of study (maximum of 18 months))
- Description of real-world ADPKD treatment patterns (percentage of subjects taking different treatments)(From Baseline to end of study (maximum of 18 months))
- Mean rate of change (%) in Mental Health Composite Scale (MCS) scores of the SF-12(From Baseline to end of study (maximum of 18 months))
- Mean ADPKD-Urinary Impact Scale (UIS) score changes(From Baseline to end of study (maximum of 18 months))
- Description of real-world ADPKD treatment patterns (number of subjects taking different treatments)(From Baseline to end of study (maximum of 18 months))