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

Overview

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.

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: October 2019

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

Clinical Trial Outcome Measures

Primary Measures

  • Mean rate of change (%) in Physical Health Composite Scale (PCS) scores of the 12-Item Short Form Survey (SF-12)
    • Time Frame: 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 Measures

  • Mean rate of change (%) in Mental Health Composite Scale (MCS) scores of the SF-12
    • Time Frame: 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-IS score changes
    • Time Frame: 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 Treatment Satisfaction Questionnaire for Medication (TSQM-9) score changes
    • Time Frame: 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-Urinary Impact Scale (UIS) score changes
    • Time Frame: 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)
    • Time Frame: From Baseline to end of study (maximum of 18 months)
  • Description of real-world ADPKD treatment patterns (percentage of subjects taking different treatments)
    • Time Frame: From Baseline to end of study (maximum of 18 months)

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Otsuka Pharmaceutical Europe Ltd
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Department, Study Director, Otsuka Europe

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