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Trial registered on ANZCTR


Registration number
ACTRN12618000197235
Ethics application status
Approved
Date submitted
8/11/2017
Date registered
7/02/2018
Date last updated
23/12/2021
Date data sharing statement initially provided
8/01/2019
Date results information initially provided
10/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A BLINDED, CONTROLLED STUDY OF THE VALUE OF OBJECTIVE MEASUREMENT IN TREATING PARKINSON’S DISEASE.
Scientific title
A BLINDED, CONTROLLED STUDY OF THE VALUE OF OBJECTIVE MEASUREMENT IN TREATING PARKINSON’S DISEASE.
Secondary ID [1] 293316 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Treat to Target
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease 305403 0
Condition category
Condition code
Neurological 304686 304686 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will wear the Parkinson's Kinetigraph-watch for 7 days prior to the baseline visit and for any future visits. This will be organised by the Florey Study Team. The PKG-watch measures levels of bradykinesia and dyskinesia and provides a report ("the Parkinson's Kinetigraph- PKG"). Participants will be classified into one of two groups. They will then consult with the study doctor who will classify them as "controlled" or "uncontrolled" (based on their symptomatology) and treat them according to their expertise. In Group 1), the participant PKG is available to the doctor, the participant is treated with anti-PD medications according to the doctor's judgement; Group 2) No PKG is available and the participant is treated according to the doctor's judgement. This cycle continues until all participants are classed as "controlled" (to a maximum of 4 visits). The time between visits is approximately 1 month (i.e. each cycle is approximately 1month long).
Participants will be seen at the hospital clinics.
Intervention adherence will be assessed by the study team by only utilising participant data where it is evident the PKG has been worn for a minimum of 5 days.
Intervention code [1] 299575 0
Treatment: Devices
Comparator / control treatment
The control group is Group 2)- patient wears PKG for 7 days at the beginning and again at the end of their participation, however no PKG available to the doctor
Control group
Active

Outcomes
Primary outcome [1] 330005 0
Severity of PD assessed using Total MDS-UPDRS scores.
Timepoint [1] 330005 0
4 months
Secondary outcome [1] 340396 0
Bradykinesia, dyskinesias and OFF time measured by the PKG.
Timepoint [1] 340396 0
4 months post study enrolment.
Secondary outcome [2] 342534 0
Measurement of quality of life symptoms as measured by the PDQ-39 assessment.
Timepoint [2] 342534 0
4 months post study enrolment.
Secondary outcome [3] 342796 0
Measurement of non-motor symptoms as measured by the SENS-PD assessment.
Timepoint [3] 342796 0
4 months post study enrolment..

Eligibility
Key inclusion criteria
- Parkinson's Disease duration of 3-12 years
- Taking 3 or more doses of levodopa a day
Minimum age
58 Years
Maximum age
76 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindication to increasing dopaminergic medications (e.g. hallucinations, orthostatic hypotension, likely resistance to dopaminergic medication).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Participants will be allocated to one of the 2 treatment groups in the order in which they present.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
280 people will be recruited into the study. Power calculations/assumptions are based on pilot data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/04/2018
Actual
5/06/2018
Date of last participant enrolment
Anticipated
3/06/2019
Actual
25/08/2019
Date of last data collection
Anticipated
20/12/2019
Actual
18/12/2019
Sample size
Target
280
Accrual to date
Final
209
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
Recruitment hospital [1] 9374 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [2] 9897 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 9898 0
Royal Hobart Hospital - Hobart
Recruitment hospital [4] 9900 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [5] 9901 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [6] 12833 0
Westmead Hospital - Westmead
Recruitment hospital [7] 12834 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [8] 15444 0
Goulburn Valley Health - Shepparton campus - Shepparton
Recruitment hospital [9] 15499 0
Beach Brain Pty Ltd - Birtinya
Recruitment postcode(s) [1] 18063 0
3065 - Fitzroy
Recruitment postcode(s) [2] 18704 0
5000 - Adelaide
Recruitment postcode(s) [3] 18705 0
7000 - Hobart
Recruitment postcode(s) [4] 18707 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 18708 0
3050 - Parkville
Recruitment postcode(s) [6] 25302 0
2145 - Westmead
Recruitment postcode(s) [7] 25303 0
2010 - Darlinghurst
Recruitment postcode(s) [8] 28785 0
3630 - Shepparton
Recruitment postcode(s) [9] 28850 0
4575 - Birtinya

Funding & Sponsors
Funding source category [1] 297940 0
Other Collaborative groups
Name [1] 297940 0
Florey Neuroscience Institute
Country [1] 297940 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Florey Neuroscience Institute
Address
30 Royal Parade, Parkville 3052 VIC
Country
Australia
Secondary sponsor category [1] 297003 0
None
Name [1] 297003 0
Address [1] 297003 0
Country [1] 297003 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298985 0
St Vincent's Hospital Melbourne
Ethics committee address [1] 298985 0
41 Victoria Parade, Fitzroy 3065 VIC
Ethics committee country [1] 298985 0
Australia
Date submitted for ethics approval [1] 298985 0
23/01/2018
Approval date [1] 298985 0
02/03/2018
Ethics approval number [1] 298985 0

Summary
Brief summary
The research project is testing a new way of managing Parkinson’s Disease. The new way of managing this involves the use of the Parkinson’s Kinetigraph (PKG) system, which includes a small, smart-watch like device that measures movements, worn on the wrist for 7 days.
In diseases such as diabetes or heart disease, “targets” exist (e.g. blood sugar levels, cholesterol levels) in order to obtain optimal health. We believe that by “measuring” Parkinson’s Disease using the PKG, we can develop targets around the movement problems in PD. These targets help us define whether a person with PD has controlled or uncontrolled movements. Previous research studies demonstrate that the PKG can identify uncontrolled symptoms and lead to changes which improve quality of life.
The aim of this project is to demonstrate that by utilising these targets, we can identify people with uncontrolled PD and treat them accordingly. If we can improve movement difficulties, we can hopefully improve quality of life.
Trial website
Nil
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78898 0
Prof Malcolm Horne
Address 78898 0
Neurology Dept
St Vincent's Hospital
PO Box 2900
Fitzroy VIC 3065
Country 78898 0
Australia
Phone 78898 0
+61414 817 562
Fax 78898 0
+6139231 3350
Email 78898 0
[email protected]
Contact person for public queries
Name 78899 0
Ms Holly Woodrow
Address 78899 0
Florey Institute of Neuroscience and Mental Health
PO Box 16085
Melbourne VIC 8007
Country 78899 0
Australia
Phone 78899 0
+61 439207518
Fax 78899 0
Email 78899 0
[email protected]
Contact person for scientific queries
Name 78900 0
Prof Malcolm Horne
Address 78900 0
Neurology Dept
St Vincent's Hospital
PO Box 2900
Fitzroy VIC 3065
Country 78900 0
Australia
Phone 78900 0
+61414 817 562
Fax 78900 0
+6139231 3350
Email 78900 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is not in line with the ethics approval given.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA blinded, controlled trial of objective measurement in Parkinson's disease.2020https://dx.doi.org/10.1038/s41531-020-00136-9
N.B. These documents automatically identified may not have been verified by the study sponsor.