A Study Measuring Quality of Life, Treatment Preference and Satisfaction of ADPKD Patients in Europe
- Conditions
- Autosomal Dominant Polycystic Kidney Disease
- Registration Number
- NCT02848521
- Lead Sponsor
- Otsuka Pharmaceutical Europe Ltd
- Brief Summary
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
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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 407
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean rate of change (%) in Physical Health Composite Scale (PCS) scores of the 12-Item Short Form Survey (SF-12) 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.
- Secondary Outcome Measures
Name Time Method Description of real-world ADPKD treatment patterns (percentage of subjects taking different treatments) From Baseline to end of study (maximum of 18 months) Mean Treatment Satisfaction Questionnaire for Medication (TSQM-9) score changes From Baseline to end of study (maximum of 18 months) 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).
Mean ADPKD-IS score changes From Baseline to end of study (maximum of 18 months) 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).
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 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.
Mean ADPKD-Urinary Impact Scale (UIS) score changes From Baseline to end of study (maximum of 18 months) 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).
Description of real-world ADPKD treatment patterns (number of subjects taking different treatments) From Baseline to end of study (maximum of 18 months)
Trial Locations
- Locations (26)
LKH Villach
🇦🇹Villach, Austria
UZ Leuven/Gasthuisberg KUL
🇧🇪Leuven, Belgium
CHU Nimes - Hôpital CAREMEAU
🇫🇷Nimes, France
Necker Hospital
🇫🇷Paris, France
Clinique La Louviere
🇫🇷Lille, France
Hopital Tenon
🇫🇷Paris, France
CHU TOURS - Hôpital Bretonneau
🇫🇷Tours, France
University Medical Center Schleswig-Holstein
🇩🇪Lubeck, Germany
Charite Berlin
🇩🇪Berlin, Germany
Universitätsmedizin Göttingen
🇩🇪Gottingen, Germany
Fundación Puigvert
🇪🇸Barcelona, Spain
Hospital Clinic
🇪🇸Barcelona, Spain
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Universitario de Getafe
🇪🇸Getafe, Spain
Edinburgh Royal Infirmary
🇬🇧Edinburgh, United Kingdom
Royal Free Hospital
🇬🇧London, United Kingdom
Queen Elizabeth University Hospital
🇬🇧Glasgow, United Kingdom
Aintree University Hospital
🇬🇧Liverpool, United Kingdom
Royal London Hospital
🇬🇧London, United Kingdom
Freeman Hospital
🇬🇧Newcastle, United Kingdom
AKH Wien
🇦🇹Vienna, Austria
University Hospital of Zurich
🇨🇭Zürich, Switzerland
UZ Brussels
🇧🇪Brussels, Belgium
University Hospital of Geneve
🇨🇭Genève, Switzerland
CHU Liège - Domaine Universitaire du Sart Tilman
🇧🇪Liege, Belgium
UCL Brussels
🇧🇪Brussels, Belgium