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Trial registered on ANZCTR


Registration number
ACTRN12617000528358
Ethics application status
Approved
Date submitted
5/01/2016
Date registered
11/04/2017
Date last updated
19/03/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
ParkinSong singing groups for people with Parkinson's disease and their caregivers
Scientific title
Staying in Tune with Parkinson’s Communication: Investigating the effects of long-term participation in ParkinSong singing groups for people with Parkinson's disease and their caregivers
Secondary ID [1] 288245 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 297176 0
Condition category
Condition code
Neurological 297392 297392 0 0
Parkinson's disease
Physical Medicine / Rehabilitation 302106 302106 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention = therapeutic singing groups (these groups include 30 mins vocal/speech exercises and warmup, 60 mins singing songs, 30 minutes socialisation over tea/coffee)

Arm 1 - weekly 120 minute singing groups for 12 months - delivered by allied health professional (music therapist, speech pathologist, allied health assistant)

Arm 2 - monthly 120 minute singing groups for 12 months - delivered by community musician volunteers

As this is not a randomised trial, participants who agree to participate can elect to join a weekly or monthly singing group or be a control participant.

Mode of delivery - face to face group sessions

Location where the intervention occurs - community venues

Intervention adherence will be measured using attendance records.
Intervention code [1] 293529 0
Rehabilitation
Comparator / control treatment
Active control groups:
These groups are the same length as the intervention groups (120 mins) and are run by volunteers through Parkinson's Victoria. Attendance is recorded for all groups.

Arm 1 - Weekly activity groups (painting/dancing/Tai Chi) for 12 months

Arm 2 - Monthly peer support groups for 12 months
Control group
Active

Outcomes
Primary outcome [1] 296938 0
Voice sound pressure level - measured via speech recordings captured via headset microphone and audio interface and calibrated with a sound level meter
Timepoint [1] 296938 0
3 months
Primary outcome [2] 296939 0
Speech intelligibility as assessed using the Speech Intelligibility Test (Yorkston & Beukelman, 1996)
Timepoint [2] 296939 0
3 months
Primary outcome [3] 296940 0
Maximum respiratory pressures - measured using a respiratory pressure meter
Timepoint [3] 296940 0
3 month
Secondary outcome [1] 319739 0
Relationship quality as measured by the QCPR (Quality of Caregiver Patient Relationship) tool - completed by both people with Parkinson's and their caregivers.
Timepoint [1] 319739 0
12 months
Secondary outcome [2] 319740 0
Depression - measured using the Depression, Anxiety & Stress Scale (DASS) in both people with Parkinson's and their caregivers.
Timepoint [2] 319740 0
12 month
Secondary outcome [3] 319741 0
Anxiety - measured using the Depression, Anxiety & Stress Scale (DASS) in both people with Parkinson's and their caregivers.
Timepoint [3] 319741 0
12 month

Eligibility
Key inclusion criteria
1. Medical diagnosis of Idiopathic Parkinson’s disease
2. Nil history of other neurological, head and neck, or respiratory disorders
3. Ability to provide informed consent to participation in study
4. Some degree of communication change reported by person with Parkinson’s, caregiver or health professional
5. Mini Mental Score > 24 or with mandatory carer support if lower Mini Mental score
6. Any changes in Parkinson’s medication regime or other medication/medical intervention to be documented
7. Any Speech Pathology or Music Therapy rehabilitation intervention during course of the study to be carefully documented
8. Any diagnosis and/or treatment of anxiety or depression to be documented
Carers:
9. Mini Mental Score > 24
10. Any diagnosis and/or treatment of anxiety or depression to be documented
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Severe cognitive impairment or memory problems
2. Severe language problems or hearing impairment

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
Analysis of covariance using baseline score as covariate.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5002 0
Kingston Centre - Cheltenham

Funding & Sponsors
Funding source category [1] 292625 0
University
Name [1] 292625 0
The University of Melbourne
Address [1] 292625 0
University of Melbourne
National Music Therapy Research Unit
234 St Kilda Road,
Southbank, 3006, Victoria
Country [1] 292625 0
Australia
Funding source category [2] 295992 0
Charities/Societies/Foundations
Name [2] 295992 0
Parkinson's Victoria
Address [2] 295992 0
587 Canterbury Road,
Surrey Hills VIC 3127
Country [2] 295992 0
Australia
Primary sponsor type
Individual
Name
Dr Jeanette Tamplin
Address
University of Melbourne
National Music Therapy Research Unit
234 St Kilda Road,
Southbank, 3006, Victoria
Country
Australia
Secondary sponsor category [1] 291341 0
Charities/Societies/Foundations
Name [1] 291341 0
Parkinson's Victoria
Address [1] 291341 0
587 Canterbury Road,
Surrey Hills VIC 3127
Country [1] 291341 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294108 0
University of Melbourne Human Ethics Review Committee
Ethics committee address [1] 294108 0
University of Melbourne
Parkville VIC 3010
Ethics committee country [1] 294108 0
Australia
Date submitted for ethics approval [1] 294108 0
08/04/2015
Approval date [1] 294108 0
08/10/2015
Ethics approval number [1] 294108 0
1544384.1
Ethics committee name [2] 297253 0
Monash Health Human Research Ethics Committee
Ethics committee address [2] 297253 0
Ethics committee country [2] 297253 0
Australia
Date submitted for ethics approval [2] 297253 0
28/07/2015
Approval date [2] 297253 0
18/09/2015
Ethics approval number [2] 297253 0
15355A

Summary
Brief summary
Parkinson’s disease (PD) is a chronic, progressive, incurable, and disabling neurological condition. In addition to the many physical symptoms at least 75% of people with PD experience impaired speech production and various mental health issues, such as depression and anxiety. This mixed-methods study aims to explore the experience of group singing for people with PD and examine the effects of long-term participation on communication and health outcomes. We will assess speech and voice function, speech-related quality of life, and communication participation, as well as wellbeing outcomes such as depression, anxiety and fatigue for both participants with PD and their caregivers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62494 0
Dr Jeanette Tamplin
Address 62494 0
Music Therapy - University of Melbourne
234 St Kilda Rd, Southbank, VIC 3006
Country 62494 0
Australia
Phone 62494 0
+61 3 8344 3003
Fax 62494 0
Email 62494 0
jeanette.tamplin@unimelb.edu.au
Contact person for public queries
Name 62495 0
Dr Jeanette Tamplin
Address 62495 0
Music Therapy - University of Melbourne
234 St Kilda Rd, Southbank, VIC 3006
Country 62495 0
Australia
Phone 62495 0
+61 3 8344 3003
Fax 62495 0
Email 62495 0
jeanette.tamplin@unimelb.edu.au
Contact person for scientific queries
Name 62496 0
Dr Jeanette Tamplin
Address 62496 0
Music Therapy - University of Melbourne
234 St Kilda Rd, Southbank, VIC 3006
Country 62496 0
Australia
Phone 62496 0
8344 3003
Fax 62496 0
Email 62496 0
jeanette.tamplin@unimelb.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary