A Study Measuring Quality of Life, Treatment Preference and Satisfaction of ADPKD Patients in Europe

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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A Prospective, Non-interventional Study Measuring Quality of Life, Treatment Preference and Treatment Satisfaction of Autosomal Dominant Polycystic Kidney Disease Patients in Europe

Conditions
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Autosomal Dominant Polycystic Kidney Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean rate of change (%) in Physical Health Composite Scale (PCS) scores of the 12-Item Short Form Survey (SF-12) | 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. | From Baseline to end of study (maximum of 18 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean rate of change (%) in Mental Health Composite Scale (MCS) scores of the SF-12 | Mean rate of change (%) in Mental Health Composite Scale (MCS) scores of the SF-12 from baseline to end of study, in the overall sample and per CKD stage. | From Baseline to end of study (maximum of 18 months) | 
| Mean ADPKD-IS score changes | Mean ADPKD-IS scores changes from baseline to end of study, in the overall sample and per CKD stage (physical, emotional and fatigue domain scores will be reported and analysed). | From Baseline to end of study (maximum of 18 months) | 
| Mean Treatment Satisfaction Questionnaire for Medication (TSQM-9) score changes | Mean TSQM-9 score changes from baseline to end of study, in the overall sample and per CKD stage (effectiveness, convenience and global satisfaction domain scores will be reported and analysed). | From Baseline to end of study (maximum of 18 months) | 
| Mean ADPKD-Urinary Impact Scale (UIS) score changes | Mean ADPKD-UIS score changes from baseline to end of study, in the overall sample and per CKD stage (frequency, urgency and nocturia domain scores will be reported and analysed). | 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) | 
| Description of real-world ADPKD treatment patterns (percentage of subjects taking different treatments) |  | From Baseline to end of study (maximum of 18 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADPKD, CKD, Rapid progressor, quality of life, DCE