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

Sponsor

Otsuka Pharmaceutical Europe Ltd (Industry)

Overall Status

Unknown status

CT.gov ID

NCT02848521

Collaborator

(none)

407

Enrollment

Locations

Duration (Months)

15.7

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autosomal Dominant Polycystic Kidney Disease

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

Study Design

Study Type:

Observational

Actual Enrollment :

407 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Oct 1, 2016

Anticipated Primary Completion Date :

Oct 1, 2019

Anticipated Study Completion Date :

Mar 1, 2020

Outcome Measures

Primary Outcome Measures

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

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-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 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-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)]
Description of real-world ADPKD treatment patterns (percentage of subjects taking different treatments) [From Baseline to end of study (maximum of 18 months)]

Other Outcome Measures

Mean ADPKD-Pain and Discomfort Scale(PDS) score change from baseline to end of study (exploratory) [From Baseline to end of study (maximum of 18 months)]
Mean ADPKD-PDS score change from baseline to end of study, in the overall sample and per CKD stage (dull kidney pain, sharp kidney pain and fullness/discomfort domain scores will be reported and analysed)
Overall odds ratio of discrete-choice experiment (DCE) for patient preference to the addition of a disease modifying treatment versus no change to local Standard of Care (SoC) [At baseline and at the end of the study (18 months)]
A descriptive of discrete-choice experiment (DCE) will be presented at baseline and at 18 months. Data from the DCE survey will be analysed using a conditional logit model. This explores the impact of each attribute (independent variable) on the patients' choice (dependent variable). Overall odds ratio of DCE for preference to the addition of a disease modifying treatment versus no change to local SoC will be displayed. The relationship between attributes of treatment and overall treatment preference as captured in DCE and relationship between stated DCE attribute preferences and persistence to ADPKD treatments will also be analysed.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country
1	AKH Wien	Vienna	Austria
2	LKH Villach	Villach	Austria
3	UCL Brussels	Brussels	Belgium
4	UZ Brussels	Brussels	Belgium
5	UZ Leuven/Gasthuisberg KUL	Leuven	Belgium
6	CHU Liège - Domaine Universitaire du Sart Tilman	Liege	Belgium
7	Clinique La Louviere	Lille	France
8	CHU Nimes - Hôpital CAREMEAU	Nimes	France
9	Hopital Tenon	Paris	France
10	Necker Hospital	Paris	France
11	CHU TOURS - Hôpital Bretonneau	Tours	France
12	Charite Berlin	Berlin	Germany
13	Universitätsmedizin Göttingen	Gottingen	Germany
14	University Medical Center Schleswig-Holstein	Lubeck	Germany
15	Fundación Puigvert	Barcelona	Spain
16	Hospital Clinic	Barcelona	Spain
17	Hospital Vall d'Hebron	Barcelona	Spain
18	Hospital Universitario de Getafe	Getafe	Spain
19	University Hospital of Geneve	Genève	Switzerland
20	University Hospital of Zurich	Zürich	Switzerland
21	Edinburgh Royal Infirmary	Edinburgh	United Kingdom
22	Queen Elizabeth University Hospital	Glasgow	United Kingdom
23	Aintree University Hospital	Liverpool	United Kingdom
24	Royal Free Hospital	London	United Kingdom
25	Royal London Hospital	London	United Kingdom
26	Freeman Hospital	Newcastle	United Kingdom