Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000940875
Ethics application status
Approved
Date submitted
25/05/2021
Date registered
19/07/2021
Date last updated
6/07/2022
Date data sharing statement initially provided
19/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
ParkinSong Online: Investigating the feasibility of online therapeutic singing groups for people with Parkinson’s Disease
Scientific title
ParkinSong Online: Investigating the feasibility of online therapeutic singing groups for people with Parkinson’s Disease
Secondary ID [1] 304201 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 321888 0
Condition category
Condition code
Neurological 319619 319619 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We aim to recruit 15-30 eligible participants with idiopathic Parkinson’s.
Consenting participants will attend a live (synchronous) 12-week ParkinSong Online group singing intervention.
Sessions will run for 90 minutes once per week (for 12 weeks; 12 session in total) and include 20 minutes of vocal warmups and speech exercises, 40 minutes of singing and 30 minutes for conversation and social interaction in small breakout groups online over morning/afternoon tea.
Experienced music therapists and speech pathologists will co-facilitate the sessions
All sessions will be recorded and distributed to participants for home practice between sessions.
Practice between sessions will be at the participant's discretion.
To monitor adherence to the intervention, an attendance checklist will be kept.
Participants will be assessed pre and post intervention on a range of speech, communication and wellbeing outcomes.
Intervention code [1] 320533 0
Rehabilitation
Intervention code [2] 320903 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327476 0
Recruitment assessed by audit of study database
Timepoint [1] 327476 0
At baseline prior to commencement
Primary outcome [2] 327478 0
Retention assessed by audit of study database
Timepoint [2] 327478 0
At 13 weeks after intervention commencement
Primary outcome [3] 327957 0
Acceptability assessed through completion of the Acceptability of Intervention Measure (AIM)
Timepoint [3] 327957 0
At 13 weeks after intervention commencement
Secondary outcome [1] 395273 0
Speech loudness - acoustic analysis of speech recordings
Timepoint [1] 395273 0
Baseline and at 7 weeks and 13 weeks after intervention commencement
Secondary outcome [2] 395275 0
Speech intelligibility – perceptual analysis of speech recordings using Direct Magnitude Estimation (DME)
Timepoint [2] 395275 0
Baseline and at 13 weeks after intervention commencement
Secondary outcome [3] 395276 0
Speech naturalness – perceptual analysis of speech recordings using Direct Magnitude Estimation (DME)
Timepoint [3] 395276 0
Baseline and at 13 weeks after intervention commencement
Secondary outcome [4] 395277 0
Communication-related quality of life - using the Dysarthria Impact Scale (DIS)
Timepoint [4] 395277 0
Baseline and at 7 and 13 weeks after intervention commencement
Secondary outcome [5] 395648 0
Health-related quality of life - using the Parkinson’s Disease Questionnaire (PDQ-39)
Timepoint [5] 395648 0
Baseline and at 13 weeks after intervention commencement
Secondary outcome [6] 395649 0
Depression, anxiety and stress - using the Depression, Anxiety and Stress Scale (DASS)
Timepoint [6] 395649 0
Baseline and at 13 weeks after intervention commencement
Secondary outcome [7] 395650 0
Apathy – using the Lille Apathy Rating Scale (LARS-SF)
Timepoint [7] 395650 0
Baseline and at 13 weeks after intervention commencement
Secondary outcome [8] 395694 0
Pre-post changes in affect - using the Affect Grid (single-item measure of affect)
Timepoint [8] 395694 0
Before (within 1 hour pre-commencement) and immediately upon completion of each online singing session (within 1 hour post-completion)
Secondary outcome [9] 397090 0
Participant safety assessed by session facilitators (i.e., music therapists) in terms of adverse events reported immediately after each session (primary outcome)
Timepoint [9] 397090 0
Before and after every online singing session.
Secondary outcome [10] 397091 0
Intervention fidelity assessed by review of session recordings (primary outcome)
Timepoint [10] 397091 0
During 12 week intervention and after 13 weeks of intervention commencement
Secondary outcome [11] 397092 0
Intervention appropriateness assessed via the Intervention Appropriateness Measure (IAM) - (primary outcome)
Timepoint [11] 397092 0
At 13 weeks post intervention commencement
Secondary outcome [12] 397093 0
Study feasibility assessed via the Feasibility of Intervention Measure (FIM) - (primary outcome)
Timepoint [12] 397093 0
At 13 weeks post intervention commencement
Secondary outcome [13] 397094 0
Costs associated with the intervention will be assessed using the CSRI (Client Service Receipt Inventory) for Parkinson's disease
Timepoint [13] 397094 0
At 13 weeks post intervention commencement
Secondary outcome [14] 397128 0
Data completeness - Proportion of follow-up assessment data completed assessed by audit of study database,
Timepoint [14] 397128 0
At 13 weeks post intervention commencement

Eligibility
Key inclusion criteria
1. Medical diagnosis of Parkinson’s disease (idiopathic only)
2. Still mobile (Hoehn & Yahr scale 1-4)
3. Nil history of other neurological, head and neck or respiratory disorders
4. Ability to communicate in English
5. Ability to provide informed consent to participation in study
6. Montreal Cognitive Assessment (MoCA) Score 18 or above (or with mandatory carer support if MoCA scores are between 10-17)
7. Some degree of communication change reported by person with Parkinson’s, caregiver or health professional
8. High speed internet access and a computer with webcam to use for the online ParkinSong sessions and remote data collection
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Severe cognitive impairment - MoCA score <10
2.. Significant hearing impairment not alleviated with hearing aids
3. Significant vision impairment not alleviated with glasses
4. Currently attending or planning to attend a Lee Silverman Voice Treatment program (LSVT Loud) during course of the study
5. Currently taking major tranquiliser medication
6. Deep brain stimulation surgery within the past 6 months

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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Feasibility results will be reported descriptively. Examination of intervention effects will be conducted via paired t tests for all quantitative outcome measures. Effect size calculations will also be conducted, in addition to the probability analyses, to determine the size of any clinically significant changes. We will conduct a thematic analysis (Braun & Clarke, 2006) of the results of the focus group interviews and an ethnographic analysis of the intervention facilitation.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/02/2022
Actual
8/02/2022
Date of last participant enrolment
Anticipated
28/02/2022
Actual
19/05/2022
Date of last data collection
Anticipated
26/08/2022
Actual
Sample size
Target
30
Accrual to date
Final
28
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 308574 0
Government body
Name [1] 308574 0
National Health and Medical Research Council (NHMRC)
Country [1] 308574 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
234 St Kilda Rd, Southbank, VIC 3006
Country
Australia
Secondary sponsor category [1] 309432 0
Charities/Societies/Foundations
Name [1] 309432 0
Parkinson’s Victoria
Address [1] 309432 0
587 Canterbury Rd, Surrey Hills VIC 3127
Country [1] 309432 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308516 0
University of Melbourne Human Research Ethics Committee
Ethics committee address [1] 308516 0
Ethics committee country [1] 308516 0
Australia
Date submitted for ethics approval [1] 308516 0
04/08/2020
Approval date [1] 308516 0
09/09/2020
Ethics approval number [1] 308516 0
2021-14465-16053-3

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

Contacts
Principal investigator
Name 110978 0
Dr Jeanette Tamplin
Address 110978 0
University of Melbourne, 234 St Kilda Rd, Southbank VIC 3006
Country 110978 0
Australia
Phone 110978 0
+61 3 8344 3003
Fax 110978 0
Email 110978 0
[email protected]
Contact person for public queries
Name 110979 0
Jeanette Tamplin
Address 110979 0
University of Melbourne, 234 St Kilda Rd, Southbank VIC 3006
Country 110979 0
Australia
Phone 110979 0
+61 3 8344 3003
Fax 110979 0
Email 110979 0
[email protected]
Contact person for scientific queries
Name 110980 0
Jeanette Tamplin
Address 110980 0
University of Melbourne, 234 St Kilda Rd, Southbank VIC 3006
Country 110980 0
Australia
Phone 110980 0
+61 3 8344 3003
Fax 110980 0
Email 110980 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Case-by-case basis at the discretion of the research team (co-ordinated by Dr Jeanette Tamplin)
Available for what types of analyses?
Only to achieve the aims in the approved proposal or for IPD meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator (Dr Jeanette Tamplin, [email protected])


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
EmbaseParkinSong Online: Protocol for a telehealth feasibility study of therapeutic group singing for people with Parkinson's disease.2021https://dx.doi.org/10.1136/bmjopen-2021-058953
N.B. These documents automatically identified may not have been verified by the study sponsor.