A multi-country, Observational, cross-sectional study to characterise advanced Parkinson’s Disease patients in Movement Disorder Centres.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000477527
• Date of registration: 14/05/2015
• Prospective Registration: No
• Primary sponsor: AbbVie
• 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.
• Date of first enrolment: 08/02/2015
• Target sample size: 2500
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615000477527.aspx
• Study type: Observational
• Study design: Purpose: Screening;Duration: Cross-sectional;Selection: Defined population;Timing: Prospective;
• Phase: Not Applicable

Countries of recruitment

Australia, Austria, Belgium, Canada, Croatia, Czech Republic, Germany, Greece, Hungary, Ireland, Israel, Italy, Romania, Russian Federation, Saudi Arabia, Slovakia, Slovenia, Switzerland, Turkey

Contacts

• Name: Dr Elisabeth Speakman

• Name: Dr Koray Onuk

Key inclusion & exclusion criteria

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.
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

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Parkinson’s Disease;
Parkinson’s Disease

Neurological - Parkinson's disease

Intervention(s)

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.

Primary Outcome(s)

Proportion of Parkinson’s Disease patients identified as Advanced Parkinson’s Disease according to physician judgment
[Cross-sectional study, single routine visit
]

Secondary Outcome(s)

Assessment of any country based variations in the definition of Advanced Parkinson’s Disease according to Physician’s judgement.[Cross-sectional study, single routine visit]

Assessment of the percentage of Advanced Parkinson’s Disease Patients considered for invasive therapies per physician’s judgement[Cross-sectional study, single routine visit]

Analysis of all of the secondary objectives per each participating country[Cross-sectional study, single routine visit]

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[Cross-sectional study, single routine visit]

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.[Cross-sectional study, single routine visit ]

Exploration of referral practices for APD patients[Cross-sectional study, single routine visit]

Secondary ID(s)

Nil

Source(s) of Monetary Support

AbbVie Pty Ltd

Ethics review

Status: Approved
Approval date:
Contact:

Clinical Research Ethics Committee of the Cork Teaching Hospitals

Status: Approved
Approval date:
Contact:

Ethics Committee of the Mediterraneo Hospital

Status: Approved
Approval date:
Contact:

Helsinki Committee of Rabin Medical Center

Status: Approved
Approval date:
Contact:

Kocaeli University Clinical Research Ethical Committee