Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000477527
Ethics application status
Approved
Date submitted
11/03/2015
Date registered
14/05/2015
Date last updated
22/12/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
A multi-country, Observational, cross-sectional study to characterise advanced Parkinson’s Disease patients in Movement Disorder Centres.
Scientific title
Observational study aimed at understanding the proportion and patient characteristics of advanced Parkinson’s Disease patients in movement disorder centres in different countries and to evaluate any regional differences.
Secondary ID [1] 286320 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
OBSERVE-PD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson’s Disease 294417 0
Condition category
Condition code
Neurological 294727 294727 0 0
Parkinson's disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This non-interventional, observational study will be conducted in a cross-sectional format. The study population will consist of adult patients diagnosed with Parkinson’s Disease, who are attending a routine clinical visit or are inpatients at the participating clinical sites in the country of interest. In order to avoid selection bias, patients will be asked for interest and enrolled in the study consecutively in each study site. Each patient will have one assessment (study visit) only, at which all data will be collected. Data collected during the study visit consists of data from patients medical records including patient demographics, PD related data, PD treatment (past and present) and co-morbidites. The following assessment scales will be used by the researcher: (1) Unified Parkinson´s Disease Rating Scale (UPDRS) part II-IV for evaluation of activities of daily living, motor functions, complications of therapy (dyskinesia), (2) UPDRS part V, Modified Hoehn and Yahr Staging for PD symptoms, progress and relative level of disability and (3) Non-Motor Symptom Assessment Scale for Parkinson’s Disease (NMSS) for evaluation of non-motor symptoms. The researcher will also assess whether the patient fulfils some predefined advanced PD criteria. One patient questionnaire, Parkinson’s disease Quality of Life Questionnaire (PDQ-8) will be administered to collect information on patient quality of life. Estimated time for the whole visit is approximately one hour.
Intervention code [1] 291363 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294492 0
Proportion of Parkinson’s Disease patients identified as Advanced Parkinson’s Disease according to physician judgment
Timepoint [1] 294492 0
Cross-sectional study, single routine visit
Secondary outcome [1] 313455 0
Assessment of the percentage of Advanced Parkinson’s Disease Patients considered for invasive therapies per physician’s judgement
Timepoint [1] 313455 0
Cross-sectional study, single routine visit
Secondary outcome [2] 313456 0
Evaluation of clinical characteristics of advanced versus non-advanced Parkinson’s Disease patients. Parameters used to select the advanced stage PD patients versus non-advanced PD patients using data from demographics, disease duration since diagnosis, Unified Parkinson’s Disease Rating Scale (UPDRS), modified Hoehn & Yahr scale, Quality of Life, co-morbidities and anti-Parkinson’s Disease medication.
Timepoint [2] 313456 0
Cross-sectional study, single routine visit
Secondary outcome [3] 313474 0
Exploration of referral practices for APD patients
Timepoint [3] 313474 0
Cross-sectional study, single routine visit
Secondary outcome [4] 313475 0
Comparison of the percentage of Advanced Parkinson’s Disease Patients identified in routine clinical practice by physician judgement to the percentage of Advanced Parkinson’s Disease patients identified based on the Delphi method Advanced Parkinson’s Disease criteria
Timepoint [4] 313475 0
Cross-sectional study, single routine visit
Secondary outcome [5] 313476 0
Analysis of all of the secondary objectives per each participating country
Timepoint [5] 313476 0
Cross-sectional study, single routine visit
Secondary outcome [6] 313477 0
Assessment of any country based variations in the definition of Advanced Parkinson’s Disease according to Physician’s judgement.
Timepoint [6] 313477 0
Cross-sectional study, single routine visit

Eligibility
Key inclusion criteria
Consecutive Parkinson’s Disease patients attending a routine visit at a participating clinic and who fulfil the following selection criteria can be included:
-adult male or female
-diagnosis of Parkinson’s Disease
-willingness to sign and date a Patient Authorization Form to use and disclose personal health information (or informed consent form if required)
-being able to speak the language of the provided patient questionnaire.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Patients in the ‘off’ stage at the time of the visit
-Participation in a concurrent clinical study
-Significant uncertainty around the diagnosis of Parkinson’s Disease

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/02/2015
Actual
8/02/2015
Date of last participant enrolment
Anticipated
31/12/2015
Actual
14/01/2016
Date of last data collection
Anticipated
Actual
29/04/2016
Sample size
Target
2500
Accrual to date
Final
2632
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA,VIC
Recruitment hospital [1] 3550 0
Westmead Hospital - Westmead
Recruitment hospital [2] 3551 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [3] 3552 0
The Townsville Hospital - Douglas
Recruitment hospital [4] 3780 0
Richmond Neurology - Richmond
Recruitment hospital [5] 3781 0
David Williams Neurology - Melbourne
Recruitment hospital [6] 3782 0
The Western Australian Neuroscience Research Institute - Nedlands
Recruitment postcode(s) [1] 9351 0
3121 - Richmond
Recruitment postcode(s) [2] 9352 0
3004 - Melbourne
Recruitment postcode(s) [3] 9353 0
4814 - Douglas
Recruitment postcode(s) [4] 9354 0
4006 - Herston
Recruitment postcode(s) [5] 9356 0
6008 - Subiaco
Recruitment postcode(s) [6] 9357 0
2145 - Westmead
Recruitment outside Australia
Country [1] 6724 0
Canada
State/province [1] 6724 0
Country [2] 6725 0
Germany
State/province [2] 6725 0
Country [3] 6726 0
Italy
State/province [3] 6726 0
Country [4] 6727 0
Belgium
State/province [4] 6727 0
Country [5] 6728 0
Ireland
State/province [5] 6728 0
Country [6] 6729 0
Austria
State/province [6] 6729 0
Country [7] 6730 0
Greece
State/province [7] 6730 0
Country [8] 6731 0
Israel
State/province [8] 6731 0
Country [9] 6732 0
Switzerland
State/province [9] 6732 0
Country [10] 6733 0
Turkey
State/province [10] 6733 0
Country [11] 6734 0
Czech Republic
State/province [11] 6734 0
Country [12] 6735 0
Croatia
State/province [12] 6735 0
Country [13] 6736 0
Hungary
State/province [13] 6736 0
Country [14] 6737 0
Romania
State/province [14] 6737 0
Country [15] 6738 0
Russian Federation
State/province [15] 6738 0
Country [16] 6739 0
Slovakia
State/province [16] 6739 0
Country [17] 6742 0
Slovenia
State/province [17] 6742 0
Country [18] 6743 0
Saudi Arabia
State/province [18] 6743 0

Funding & Sponsors
Funding source category [1] 290899 0
Commercial sector/Industry
Name [1] 290899 0
AbbVie Pty Ltd
Country [1] 290899 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Level 7, 241 O’Riordan Street
MASCOT NSW 2020
Country
Australia
Secondary sponsor category [1] 289581 0
None
Name [1] 289581 0
Address [1] 289581 0
Country [1] 289581 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292501 0
Helsinki Committee of Rabin Medical Center
Ethics committee address [1] 292501 0
39 Jabotinski St. Petah Tikva 49100
Ethics committee country [1] 292501 0
Israel
Date submitted for ethics approval [1] 292501 0
Approval date [1] 292501 0
28/12/2014
Ethics approval number [1] 292501 0
0639-14-RMC
Ethics committee name [2] 292502 0
Kocaeli University Clinical Research Ethical Committee
Ethics committee address [2] 292502 0
Umuttepe Central Campus, 41380 Izmit/Kocaeli, Turkey (Note: no street name, EC is located on the campus, inside the medical faculty)
Ethics committee country [2] 292502 0
Turkey
Date submitted for ethics approval [2] 292502 0
Approval date [2] 292502 0
16/12/2014
Ethics approval number [2] 292502 0
KIA 2014/287
Ethics committee name [3] 292515 0
Ethics Committee of the Mediterraneo Hospital
Ethics committee address [3] 292515 0
Mediterraneo Hospital, 8-12 Ilias st., P.C. 166 75, Glyfada, Athens
Ethics committee country [3] 292515 0
Greece
Date submitted for ethics approval [3] 292515 0
Approval date [3] 292515 0
20/01/2015
Ethics approval number [3] 292515 0
28
Ethics committee name [4] 292516 0
Clinical Research Ethics Committee of the Cork Teaching Hospitals
Ethics committee address [4] 292516 0
Lancaster Hall, 6 Little Hanover Street, Cork
Ethics committee country [4] 292516 0
Ireland
Date submitted for ethics approval [4] 292516 0
Approval date [4] 292516 0
17/01/2015
Ethics approval number [4] 292516 0
ECM 4 (p) 03/02/15

Summary
Brief summary
This multi-country, observational study will primarily determine the proportion of PD patients treated at Movement Disorder Centers (MDC), who are identified as advanced PD patients.
This study will also compare the proportion of PD patients identified as “advanced” based on routine clinical practice (physician’s judgement) to the proportion of “advanced” patients identified based on a set of consensus criteria generated by Delphi method. The main purpose of this study is to enhance the understanding of the proportion and patient characteristics of advanced PD patients in Movement Disorder Centers in different regions and to evaluate any regional differences.
Trial website
Trial related presentations / publications
Fasano A. Lopiano, L. et al (2017) Advanced’ Parkinson’s Disease Characteristics in Clinical Practice: Results from the OBSERVE-PD Study, a Cross-sectional Observational Study of 2615 Patients. Poster accepted for 12th World Federation of Neuroscience Congress; September 17-21st 2017; Opatija, Crotia

Fasano A. Lopiano, L. et al (2016) Defining ‘Advanced’ Parkinson’s Disease in Clinical Practice: Results from the OBSERVE-PD Study, a Cross-sectional Observational Study of 2615 Patients. Poster accepted for 4TH World Parkinson's Congress; 20-23rd of September 2016; Portland, USA
Public notes

Contacts
Principal investigator
Name 55586 0
Prof Victor Fung
Address 55586 0
Department of Neurology, Westmead Hospital, Cnr Darcy Rd & Bridge St, Westmead, NSW 2145, Australia
Country 55586 0
Australia
Phone 55586 0
+61 2 98456793
Fax 55586 0
+61 2 9845 5000
Email 55586 0
[email protected]
Contact person for public queries
Name 55587 0
Dr Elisabeth Speakman
Address 55587 0
AbbVie Ltd
Vanwall Business Park
Maidenhead
Berkshire SL6 4XE
Country 55587 0
United Kingdom
Phone 55587 0
+44 162 856 10 90
Fax 55587 0
Email 55587 0
[email protected]
Contact person for scientific queries
Name 55588 0
Dr Koray Onuk
Address 55588 0
AbbVie Europe
10, rue d'Arcueil
94150, Rungis
Country 55588 0
France
Phone 55588 0
+33(0)1 4560 2793
Fax 55588 0
Email 55588 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIVideo-based Parkinson’s disease assessments in a nationwide cohort of Fox Insight participants2021https://doi.org/10.1016/j.prdoa.2021.100094
N.B. These documents automatically identified may not have been verified by the study sponsor.