Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000008224
Ethics application status
Approved
Date submitted
3/12/2008
Date registered
7/01/2009
Date last updated
13/11/2018
Date data sharing statement initially provided
13/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Clinical and Economic Measures to Evaluate Disease Status and Progression in Parkinson’s Disease
Scientific title
Clinical and Economic Measures to Evaluate Disease Status and Progression in Parkinson’s Disease
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson disease 4055 0
Condition category
Condition code
Neurological 4264 4264 0 0
Parkinson's disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Parkinson's disease is a chronic and progressive neurological condition affecting the basil ganglia deep within the brain leading to a reduction in the size and speed of sequential movements. The disease results in significant cost to the health care system including medication and medical and allied health services. This
prospective cohort study will evaluate primary and secondary clinical, health related quality of life and cost data over a 12 month period for people with Parkinson.
Intervention code [1] 3779 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5148 0
Clinical measures include United Parkinson Disease Rating Scale (UPDRS), Modified Dyskinesia Rating Scale, The 39-Item Parkinson's Disease Questionnaire (PDQ-39), European Quality of Life Group Five Dimensions scale (EUROQOL-5D), 10m walking test, Timed Up & Go, Parkinson Disease Fatigue Scale (PDF16), Geriatric Depression Scale, Motor fluctuation diary
Timepoint [1] 5148 0
0, 3 & 12 months
Primary outcome [2] 5149 0
Economic measures assessed at baseline and 12 months only collected via questionnaire administered by a health care professional include Employment status, Income change, Leisure activities, Government allowances, Informal care assistance, Formal carer, Home Help, Community-based services. Patient level cost and healthcare utilisation data will be estimated for each patient. Regression analyses will be used identify the main socioeconomic predictors of cost and resource use.
Timepoint [2] 5149 0
0 & 12 months
Primary outcome [3] 5150 0
Economic measures assessed on a monthly basis via telephone questionnaire include Hospital admission, Primary health care services, Non-admitted patient services and Medication. Patient level cost and healthcare utilisation data will be estimated for each patient. Regression analyses will be used identify the main socioeconomic predictors of cost and resource use.
Timepoint [3] 5150 0
monthly
Secondary outcome [1] 8667 0
Participants' permission will be obtained to directly contact Medicare Australia to access individual claims data relating to costs associated with visits to any Southern Health facility, other medical visits, diagnostic tests and other items included on the Commonwealth Medicare Benefits Schedule for each patient will be retrieved. Patient level cost and healthcare utilisation data will be estimated for each patient. Regression analyses will be used identify the main socioeconomic predictors of cost and resource use.
Timepoint [1] 8667 0
12 months prior to enrolment and 12 months of active follow-up (enrolment period)

Eligibility
Key inclusion criteria
A confirmed diagnosis of idiopathic Parkinson, informed consent (including to access Medicare Australia claims data), carer participation in case of cognitive impairment (Mini-Mental State Examination (MMSE<24/30)), and ability to attend assessment clinics and to complete questionnaires over a 12-month period.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Hoehn & Yahr Stage V, non-ambulatory, or have co-existing neurological conditions which are related to significant motor and cognitive function impairment, are unwilling to provide informed consent, or to participate in a clinical trial.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/01/2007
Actual
16/03/2007
Date of last participant enrolment
Anticipated
Actual
26/09/2008
Date of last data collection
Anticipated
Actual
2/12/2009
Sample size
Target
100
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1324 0
3000-3999
Recruitment postcode(s) [2] 1325 0
4000-4999
Recruitment postcode(s) [3] 1326 0
2000-2999
Recruitment postcode(s) [4] 1327 0
5000-5999

Funding & Sponsors
Funding source category [1] 4238 0
Charities/Societies/Foundations
Name [1] 4238 0
National Parkinson Foundation
Country [1] 4238 0
United States of America
Primary sponsor type
Hospital
Name
Southern Health
Address
246 Clayton Road
Clayton VIC 3168
Country
Australia
Secondary sponsor category [1] 3811 0
University
Name [1] 3811 0
Monash University
Address [1] 3811 0
Clayton campus
Cnr Wellington Road and Princes Highway
Clayton VIC 3800
Country [1] 3811 0
Australia
Other collaborator category [1] 500 0
University
Name [1] 500 0
The University of Melbourne
Address [1] 500 0
School of Physiotherapy
202 Berkeley Street
Carlton VIC 3010
Country [1] 500 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6290 0
Southern Health Human Research Ethics Committee
Ethics committee address [1] 6290 0
Ethics committee country [1] 6290 0
Australia
Date submitted for ethics approval [1] 6290 0
Approval date [1] 6290 0
20/12/2006
Ethics approval number [1] 6290 0
06107B
Ethics committee name [2] 6291 0
Monash University Standing Committee on Ethics in Research Involving Humans
Ethics committee address [2] 6291 0
Ethics committee country [2] 6291 0
Australia
Date submitted for ethics approval [2] 6291 0
Approval date [2] 6291 0
03/01/2007
Ethics approval number [2] 6291 0
2006/728MCC

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29189 0
Address 29189 0
Country 29189 0
Phone 29189 0
Fax 29189 0
Email 29189 0
Contact person for public queries
Name 12346 0
Anna Murphy
Address 12346 0
Kingston Centre
Cnr Kingston and Warrigal Roads
Cheltenham VIC 3192
Country 12346 0
Australia
Phone 12346 0
+61392651453
Fax 12346 0
Email 12346 0
[email protected]
Contact person for scientific queries
Name 3274 0
Anna Murphy
Address 3274 0
Kingston Centre
Cnr Kingston and Warrigal Roads
Cheltenham VIC 3192
Country 3274 0
Australia
Phone 3274 0
+61392651453
Fax 3274 0
Email 3274 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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 AIQuantifying the profile and progression of impairments, activity, participation, and quality of life in people with Parkinson disease: protocol for a prospective cohort study2009https://doi.org/10.1186/1471-2318-9-2
N.B. These documents automatically identified may not have been verified by the study sponsor.