Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000452897
Ethics application status
Approved
Date submitted
6/02/2021
Date registered
19/04/2021
Date last updated
24/02/2022
Date data sharing statement initially provided
19/04/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pitch Perfect for Parkinson's
Scientific title
Pitch Perfect for Parkinson's – Effect of a group singing intervention on vocal intensity for speech and voice disorders in people with Parkinson’s disease
Secondary ID [1] 303368 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease 320637 0
Hypophonia 320638 0
Condition category
Condition code
Neurological 318497 318497 0 0
Parkinson's disease
Physical Medicine / Rehabilitation 318833 318833 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will attend a series of 8 group singing workshops via Telehealth, over 8 weeks. This will be run by a speech pathologist and a music therapist. Concurrent workshop programs will be conducted for 3 groups of maximum 8 people. Each workshop will involve 25 minutes of physical, breathing and vocal warm-up activities; opportunity for social interaction with other group members/carers; and 25 minutes of choral singing of familiar songs. There will be a session attendance and participation checklist to monitor for adherence. During all vocal tasks shaping and cuing will be provided to ensure healthy vocal quality and emphasising vocal loudness using the cue ‘think LOUD’, known to be effective for improving vocal loudness and intelligibility in people with PD. A pre-assessment battery including repeated baseline will be conducted 1-2 weeks prior to the workshops commencing, repeated 1-2 weeks post workshop completion, and a maintenance assessment at around 10 weeks post workshop completion. All assessments will also be conducted via Telehealth.
Intervention code [1] 319681 0
Treatment: Other
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326450 0
Change in vocal intensity (as defined by dB SPL) in patients measured using Voice Analyst app.
Timepoint [1] 326450 0
Post-participation assessment within 1-2 weeks of completing 8-week intervention and maintenance assesment at 9-11 week post completion of the intervention
Secondary outcome [1] 391530 0
Change in maximum phonation time (MPT, measured in seconds) using Voice Analyst
Timepoint [1] 391530 0
Post-participation assessment within 1-2 weeks of completing 8-week intervention and maintenance assesment at 9-11 week post completion of the intervention
Secondary outcome [2] 392668 0
Change in vocal pitch range using Voice Analyst (measured in Hz)
Timepoint [2] 392668 0
Post-participation assessment within 1-2 weeks of completing 8-week intervention and maintenance assesment at 9-11 week post completion of the intervention
Secondary outcome [3] 392669 0
To describe the psychosocial impact of voice disorders (as measured using the Voice Handicap Index)
Timepoint [3] 392669 0
Post-participation assessment within 1-2 weeks of completing 8-week intervention and maintenance assesment at 9-11 week post completion of the intervention
Secondary outcome [4] 392670 0
Change in communicative effectiveness (measured using the Communicative Effectiveness Survey)
Timepoint [4] 392670 0
Post-participation assessment within 1-2 weeks of completing 8-week intervention and maintenance assesment at 9-11 week post completion of the intervention
Secondary outcome [5] 392671 0
Change in social isolation (as measured using the Friendship Scale)
Timepoint [5] 392671 0
Post-participation assessment within 1-2 weeks of completing 8-week intervention and maintenance assesment at 9-11 week post completion of the intervention
Secondary outcome [6] 392672 0
Describe the experience of participants/carers using Telehealth (semi-structured questionnaire)
Timepoint [6] 392672 0
Post-participation assessment within 1-2 weeks of completing 8-week intervention and maintenance assesment at 9-11 week post completion of the intervention

Eligibility
Key inclusion criteria
1. Diagnosis of idiopathic Parkinson’s disease
2. Functional English language skills
3.Sufficient access to technology to access videoconferencing software and apps, and sufficient skills in independent use, or access to a regular support person that has skills in its use.
4. Self-reported voice and/or speech changes related to PD diagnosis
5. Stable on current PD medications
6. Willingness to provide informed consent and willingness to participate with the study requirements.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participating in other speech pathology intervention during the study period.
2. Concomitant neurological condition, e.g. stroke, dementia, that have a known impact on communication skills.
3. Known laryngeal pathology.

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



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
24/03/2021
Date of last participant enrolment
Anticipated
16/06/2021
Actual
16/07/2021
Date of last data collection
Anticipated
1/09/2021
Actual
1/10/2021
Sample size
Target
24
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18582 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 18583 0
Concord Repatriation Hospital - Concord
Recruitment postcode(s) [1] 32956 0
2050 - Camperdown
Recruitment postcode(s) [2] 32957 0
2139 - Concord

Funding & Sponsors
Funding source category [1] 307781 0
Hospital
Name [1] 307781 0
Royal Prince Alfred Hospital
Country [1] 307781 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
50 Missenden Rd
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 308494 0
None
Name [1] 308494 0
None
Address [1] 308494 0
None
Country [1] 308494 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307800 0
Sydney Local Health District HREC
Ethics committee address [1] 307800 0
Ethics committee country [1] 307800 0
Australia
Date submitted for ethics approval [1] 307800 0
Approval date [1] 307800 0
29/01/2021
Ethics approval number [1] 307800 0

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

Contacts
Principal investigator
Name 108542 0
Ms Jessica Lamond
Address 108542 0
Speech Pathlogy Department
RPA Hospital
50 Missenden Rd
Camperdown NSW 2050
Country 108542 0
Australia
Phone 108542 0
+61 2 9515 9845
Fax 108542 0
Email 108542 0
[email protected]
Contact person for public queries
Name 108543 0
Jessica Lamond
Address 108543 0
Speech Pathlogy Department
RPA Hospital
50 Missenden Rd
Camperdown NSW 2050
Country 108543 0
Australia
Phone 108543 0
+61 2 9515 9845
Fax 108543 0
Email 108543 0
[email protected]
Contact person for scientific queries
Name 108544 0
Jessica Lamond
Address 108544 0
Speech Pathlogy Department
RPA Hospital
50 Missenden Rd
Camperdown NSW 2050
Country 108544 0
Australia
Phone 108544 0
+61 2 9515 9845
Fax 108544 0
Email 108544 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


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.