Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000877381
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
17/06/2026
Date registered
Help: Date registered
17/07/2026
Date last updated
Help: Date last updated
17/07/2026
Date data sharing statement initially provided
Help: Data sharing statement date
17/07/2026
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
A multidisciplinary Parkinson’s Disease Strategy Training Program: Measuring the impact on client’s quality of life and carer stress
Scientific title
A multidisciplinary Parkinson’s Disease Strategy Training Program: Measuring the impact on client’s quality of life and carer stress
Additional trial identifiers [1] 317604 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Parkinson's disease 342374 0
Condition category
Condition code
Neurological 338507 338507 0 0
Parkinson's disease
Public Health 338641 338641 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Intervention group: Combined multidisciplinary allied health input: Participants received 1:1 therapy and input tailored to each individual. Participants were assessed at an initial needs assessment prior to commencing multidisciplinary program and referred to any discipline (physiotherapy, occupational therapy, speech pathology, dietetic and social work) as required. Cross referrals to other disciplines would occur during the program if subsequent need was identified. Therapy could be in the form of education, strategies, exercises or aids/ equipment. Therapy will be delivered face to face in an outpatient setting at a hospital. Appointments are routinely 60 minutes duration and the number and frequency of appointments is determined by the functional goals identified in the initial assessment. The maximal number of appointments for any patient is x4 for each discipline. Patients may see one or two different disciplines each week dependent on patient/ caregiver and clinician appointment availability. Attendance to appointments will be collected, and each discipline will monitor adherence to interventions provided.

Control group: Best medical input only: Best medical therapy is defined in this study as usual medical care from a specialised neurologist; pharmacological (oral, subcutaneous, intestinal gel) and DBS. The type and frequency of therapy is determined by the specialist neurologist to maximise function and quality of life. This is delivered face to face in an outpatient setting at a hospital. Participants in this group will be measured at baseline and then 6 months post initial assessment. Appointments are routinely 30mins duration.

Participants who are stable and require no medication changes over a 6 month period were invited to participate in the medical only (control) arm of the study. Those that required multidisciplinary intervention were invited to participate in the intervention arm of the study.
Intervention code [1] 334427 0
Rehabilitation
Description of the comparator or control
Best medical therapy is defined in this study as usual medical care from a specialised neurologist; pharmacological (oral, subcutaneous, intestinal gel) and Deep Brain Stimulation (DBS). The type and frequency of therapy is determined by the specialist neurologist to maximise function and quality of life. Appointments ranged from 30-60 minutes dependent on the clients needs or concerns.
Control group
Active

Outcomes
Primary outcome [1] 345794 0
Health related quality of life
Timepoint [1] 345794 0
Baseline, post-intervention completion, 3 month follow up post-intervention period
Secondary outcome [1] 463324 0
Carer stress
Timepoint [1] 463324 0
Baseline, post-intervention completion, 3 month follow up post-intervention period

Eligibility
Key inclusion criteria
Participants were required to have a diagnosis of idiopathic Parkinson’s Disease (PD) and be medically stable. Participants of all ages were invited to participate and required a Mini Mental State Examination (MMSE) of 24 or above. Participants who had received multidisciplinary allied health input in the past 4 months from any service were excluded as the impact of previous strategy training might influence their results. Patients were able to continue any self-management programs such as group exercise etc. All participants in this study required someone who identified as a carer. Caregivers were defined as an individual who provided care and support to the participant on a daily basis.
For the medical input only cohort, patients were deemed eligible if they had stable symptoms and no significant change to their pharmacological management as these factors could impact their HRQoL.
For the combined multidisciplinary allied health input cohort, patients were deemed eligible if requirement for allied health input was identified by the attending specialist neurologist and/or Parkinson’s disease nurse consultant e.g. dysphagia requiring speech pathology assessment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Diagnosis of Atypical Parkinson's or Parkinsonism
Participants with no caregivers

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This project aimed to recruit 30 participants in each group (total 60).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
11/05/2022
Date of last participant enrolment
Anticipated
Actual
23/04/2024
Date of last data collection
Anticipated
Actual
27/11/2024
Sample size
Target
60
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 322158 0
Hospital
Name [1] 322158 0
Eastern Health
Country [1] 322158 0
Australia
Primary sponsor type
Hospital
Name
Eastern health
Address
Country
Australia
Secondary sponsor category [1] 325054 0
None
Name [1] 325054 0
Address [1] 325054 0
Country [1] 325054 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320687 0
Eastern Health Human Research Ethics Committee
Ethics committee address [1] 320687 0
Ethics committee country [1] 320687 0
Australia
Date submitted for ethics approval [1] 320687 0
09/09/2020
Approval date [1] 320687 0
01/04/2021
Ethics approval number [1] 320687 0

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

Contacts
Principal investigator
Name 151290 0
Dr Aan Terrens
Address 151290 0
Eastern Health, 5 Arnold St, Box Hill, Victoria, Australia, 3129
Country 151290 0
Australia
Phone 151290 0
+61 390918880
Fax 151290 0
Email 151290 0
[email protected]
Contact person for public queries
Name 151291 0
Aan Terrens
Address 151291 0
Eastern Health, 5 Arnold St, Box Hill, Victoria, Australia, 3129
Country 151291 0
Australia
Phone 151291 0
+61 390918880
Fax 151291 0
Email 151291 0
[email protected]
Contact person for scientific queries
Name 151292 0
Aan Terrens
Address 151292 0
Eastern Health, 5 Arnold St, Box Hill, Victoria, Australia, 3129
Country 151292 0
Australia
Phone 151292 0
+61 390918880
Fax 151292 0
Email 151292 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.