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Trial registered on ANZCTR


Registration number
ACTRN12611001153909
Ethics application status
Approved
Date submitted
27/10/2011
Date registered
3/11/2011
Date last updated
21/01/2020
Date data sharing statement initially provided
21/01/2020
Date results provided
21/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of Parkinson-related quality of life and cost effectiveness of a comprehensive service delivery model compared to usual care for the management of people with Parkinson’s disease.
Scientific title
Comparison of Parkinson-related quality of life and cost effectiveness of a comprehensive service delivery model compared to usual care for the management of people with Parkinson’s disease.
Secondary ID [1] 273283 0
Nil
Universal Trial Number (UTN)
U1111-1125-5122
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease 279049 0
Condition category
Condition code
Neurological 279239 279239 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Victorian Comprehensive Parkinson’s Program (VCPP) is an alternative care model that involves an inter-professional team approach to the management of the complex array of motor and non motor symptoms that occur with PD.Treatment aims to limit the rate and level of progression and to provide strategies to enable people to compensate for their impairments so that people with PD and others in their lives can enjoy the highest possible quality of life.
The overall duration of the data collection for the project will be over four years/48 months.
Intervention code [1] 283631 0
Prevention
Intervention code [2] 283632 0
Treatment: Other
Comparator / control treatment
Conventional care where a typical model of care currently involves a person diagnosed with Parkinson's disease being seen by a general medical practitioner and then referred to a specialist, usually to a neurologist, with short visits on a three or six monthly basis. Specialist care mainly concerns medication.
The overall duration of the data collection for the project will be over four years/48 months.
Control group
Active

Outcomes
Primary outcome [1] 279865 0
The primary outcome measure is:
Parkinson's Disease Quality Of Life (PDQ39) as measured on the PDQ39.
Timepoint [1] 279865 0
Measured at baseline, 12 months, 2 years and 3 years.
Secondary outcome [1] 294614 0
Global disability as measured on the most recent version of the United Parkinson Disease Rating Scale (UPDRS).
Timepoint [1] 294614 0
Measured at baseline, 12 months, 2 years and 3 years.
Secondary outcome [2] 294615 0
Quality of life as measured by the EuroQol-5D and Health related quality of life measured by AQol-8D
Timepoint [2] 294615 0
Measured at baseline, 12 months, 2 years and 3 years.
Secondary outcome [3] 294616 0
Dyskinesia Rating Scale validated by Goetz et al (1994)
Timepoint [3] 294616 0
Measured at baseline, 12 months, 2 years and 3 years.
Secondary outcome [4] 294617 0
Fatigue as measured using the Parkinson Disease Fatigue Scale (PDF16), Apathy Scale and Epworth sleep scale.
Timepoint [4] 294617 0
Measured at baseline, 12 months, 2 years and 3 years.
Secondary outcome [5] 294618 0
Depression as measured by the Geriatric Depression Scale.
Timepoint [5] 294618 0
Measured at baseline, 12 months, 2 years and 3 years.
Secondary outcome [6] 294619 0
Walking speed as measured by the 6m walking test.
Timepoint [6] 294619 0
Measured at baseline, 12 months, 2 years and 3 years.
Secondary outcome [7] 294620 0
Nutrition risk assessment as measured by Malnutrition Universal Screening Tool (MUST) and Mini-Nutritional Assessment (MNA) short form.
Timepoint [7] 294620 0
Measured at baseline, 12 months, 2 years and 3 years.
Secondary outcome [8] 294621 0
Anxiety as measured by the BECK anxiety index.
Timepoint [8] 294621 0
Measured at baseline, 12 months, 2 years and 3 years.
Secondary outcome [9] 294622 0
Cognition as measured by the Parkinsons's Disease Cognitive rating scale and Mini Mental State Exam.
Timepoint [9] 294622 0
Measured at baseline, 12 months, 2 years and 3 years.
Secondary outcome [10] 294623 0
Motor fluctuations diary (previous 48 hrs) as measured by a patient movement diary:
For each hourly time period over the next 48 hours tick the box indicating your predominant status during most of that period.
OFF = Time when medication has worn off and is no longer providing benefit with regard to mobility, slowness and stiffness.
ON = Time when medication is providing benefit with regard to mobility, slowness, and stiffness.
DYSKINESIA = Involuntary twisting, turning movements. These movements are an effect of medication and occur during ON time.
NON-TROUBLESOME DYSKINESIA does not interfere with function or cause meaningful discomfort.
TROUBLESOME DYSKINESIA refers to involuntary twisting, turning movements that interfere with function or cause meaningful discomfort
Tremor is shaking back and forth and is not considered dyskinesia.
Timepoint [10] 294623 0
Measured at baseline, 12 months, 2 years and 3 years.
Secondary outcome [11] 294624 0
Self reported falls (within the past 6 months)
Timepoint [11] 294624 0
Measured at baseline, 6months, 12 months, 18months, 24 months, 30 months and 3 years.
Secondary outcome [12] 294625 0
The direct costs of delivering each of the programs.
We will seek participants? permission to obtain details of costs associated with visits to any Southern Health Care Network (SHCN) facility during the course of the 3 year follow-up. The questionnaires will be used to record frequency of visits and length of stay where appropriate to non-SHCN facilities, and costs inferred from similar SHCN visits.
Timepoint [12] 294625 0
Measured at baseline, 6months, 12 months, 18months, 24 months, 30 months and 3 years.
Secondary outcome [13] 294626 0
The number and type of primary health care visits during the 3 year follow-up period (from patient 12 monthly questionnaires and Medicare Australia claims data).
Timepoint [13] 294626 0
Measured at baseline, 6months, 12 months, 18months, 24 months, 30 months and 3 years.
Secondary outcome [14] 294627 0
Medication type and usage (from patient 6 monthly questionnaires and Medicare Australia data).
Timepoint [14] 294627 0
Measured at baseline, 6months, 12 months, 18months, 24 months, 30 months and 3 years.
Secondary outcome [15] 294628 0
The number of hospitalizations and length of stay, including non-admitted patient episodes (from patient 6 monthly questionnaires and Southern Health administrative and cost data).
Timepoint [15] 294628 0
Measured at baseline, 6months, 12 months, 18months, 24 months, 30 months and 3 years.
Secondary outcome [16] 294629 0
Burden of care will be assessed through the carer strain using the Zarit burden interview and neuropsychiatric inventory.
Timepoint [16] 294629 0
Measured at baseline, 12 months, 2 years and 3 years.

Eligibility
Key inclusion criteria
A diagnosis of idiopathic PD by a neurologist
Living in the community
Aged 21-85 years
Hoehn & Yahr stage 1-1V (24)
Provision of informed consent, including permission to access Medicare Australia data and hospital records from participating healthcare facilities
Ability to travel to assessment clinics or consent to be assessed in their home
Care giver participation in case of cognitive impairment (MMSE < 24/30)
Be capable of completing study questionnaires over 3 year period alone, or with assistance from another person.
Minimum age
21 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Are unable to communicate in English as it is not feasible to provide interpreters
Hoehn-Yahr Stage V or higher and non-ambulatory patients
Unable or unwilling to provide informed consent
Participation in a clinical (drug) trial

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)
# Participants will be recruited from referrals by general practitioners to the Monash Medical Centre Neurology Department and referrals made to the VCPP.
# Recruitment will occur after referral to one or other of the services. Thus the study employs a deterministic method of allocation without true randomization (quasi-experimental).
# Patients referred by their community doctor to one service are compared with patients who are referred to the other service.
# All patients referred to either service during the study recruitment period will be screened for enrollment
# Those meeting the inclusion criteria will be offered the opportunity to participate in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
# Baseline patient characteristics will be recorded and analyzed to identify any sources of bias or potential confounding factors between the two samples. Recruitment will continue until the required number of participants have commenced into each arm of the study. Referral rate for both services is approximately 5-10/week, and thus, based on our experiences from our previous NPF funded project, it is expected to take approximately 18 months to recruit the required number of patients
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2011
Actual
3/01/2012
Date of last participant enrolment
Anticipated
Actual
20/12/2016
Date of last data collection
Anticipated
Actual
20/12/2016
Sample size
Target
180
Accrual to date
Final
180
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 284112 0
Charities/Societies/Foundations
Name [1] 284112 0
National Parkinson Foundation
Country [1] 284112 0
United States of America
Primary sponsor type
Hospital
Name
Southern Health
Address
Clinical Research Centre Movement Disorders & Gait
Warrigal Rd, Cheltenham, Victoria, 3192
Country
Australia
Secondary sponsor category [1] 269074 0
University
Name [1] 269074 0
La Trobe University
Address [1] 269074 0
School Allied Health, College of Science, Health & Engineering, La Trobe University, Kingsbury Drive, Bundoora, Victoria 3086
Country [1] 269074 0
Australia
Other collaborator category [1] 252318 0
University
Name [1] 252318 0
Monash University
Address [1] 252318 0
Clayton Campus
Wellington Road
Monash University
Victoria 3800
Country [1] 252318 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272065 0
Southern Health Human Research Ethics Committee
Ethics committee address [1] 272065 0
Ethics committee country [1] 272065 0
Australia
Date submitted for ethics approval [1] 272065 0
Approval date [1] 272065 0
18/07/2011
Ethics approval number [1] 272065 0
10015A

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

Contacts
Principal investigator
Name 33305 0
Prof Professor Robert Iansek
Address 33305 0
Monash Health, The Kingston Centre, Clinical Research Centre Movement Disorders and Gait, 400 Warrigal Rd, Cheltenham, Vic, 3192
Country 33305 0
Australia
Phone 33305 0
+61 3 92651393
Fax 33305 0
Email 33305 0
robert.iansek@monash.edu
Contact person for public queries
Name 16552 0
Anna Murphy
Address 16552 0
Monash Health, The Kingston Centre, Clinical Research Centre Movement Disorders and Gait, 400 Warrigal Rd, Cheltenham, Vic, 3192
Country 16552 0
Australia
Phone 16552 0
+61 3 9265 1399
Fax 16552 0
+61 3 9265 1577
Email 16552 0
c
Contact person for scientific queries
Name 7480 0
Dr Anna Murphy
Address 7480 0
Kingston Centre Clinical Research Centre Movement Disroders and Gait Warrigal Rd, Cheltenham, Vic, 3192
Country 7480 0
Australia
Phone 7480 0
+61 3 9265 1453
Fax 7480 0
+61 3 9265 1577
Email 7480 0
annat.murphy@monashhealth.org

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
No additional documents have been identified.