Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000707662
Ethics application status
Approved
Date submitted
9/06/2023
Date registered
3/07/2023
Date last updated
6/07/2024
Date data sharing statement initially provided
3/07/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of Personalised Music Therapy on outcomes for hospitalised patients with dementia
Scientific title
Effect of Personalised Music Therapy on Behavioural and Psychological Symptoms in Dementia and Delirium in older hospital inpatients
Secondary ID [1] 309868 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 330318 0
Neuropsychiatric symptoms 330319 0
Delirium 330320 0
Condition category
Condition code
Neurological 327172 327172 0 0
Dementias
Neurological 327227 327227 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Personalised music therapy available to participant at any time during their admission (via portable speaker or headphones) and to be offered throughout the day (and evenings if appropriate). Staff will enter all intervention sessions into the participant's electronic medical record, as per standard care recording of shift activities.
Introductory session will be carried out following recruitment to gather participant’s music preferences and compile an individualised digital profile and music library. This will be administered in a face to face session by a member of the research team, with the participant's carer/relative present if possible, and will take approximately 30 minutes.
Intervention code [1] 326293 0
Treatment: Other
Comparator / control treatment
Neuropsychiatric inventory scores will be collected for intervention participants (as well as psychotropic medication use data) and compared to a historical control group (drawn from inpatients in the Acute Aged Care Extended behavioural unit in the Prince of Wales Hospital from Sept 2022-May 2023). This control group received no music therapy and received standard care which includes non-pharmacological strategies (eg. colouring books, fiddle mats, verbal reassurance/distraction) and pharmacological interventions (eg. psychotropic medications if absolutely necessary).
All control participants (and/or their Person Responsible) will be contacted by phone to gain consent for their data to be used in the study analyses. A copy of the consent form and information sheet on the study will be sent to each participant (and/or their Person Responsible).
Control group
Historical

Outcomes
Primary outcome [1] 335046 0
Change in any neuropsychiatric symptom (incidence and/or severity) as measured by serial Neuropsychiatric Inventory Questionnaires (NPI-Q). These will be completed at least twice a week by the research team in collaboration with nursing and/or medical staff caring for the participant.
Timepoint [1] 335046 0
Change in any neuropsychiatric symptom (incidence and/or severity) for each participant will be measured by serial Neuropsychiatric Inventory Questionnaires (NPI-Q). These will be completed upon recruitment, then at least twice a week for the duration of their admission/intervention by the research team in collaboration with nursing and/or medical staff caring for the participant.
The duration for which each participant undergoes intervention will vary depending on their illness and hospital length of stay.
The study will run for 6 months.
Primary outcome [2] 335047 0
Is digitalised, personalised music therapy a feasible intervention to incorporate into standard inpatient care for people with dementia.
This will be assessed using the Staff questionnaires completed by a staff participant who has administered the intervention (one questionnaire collected for each study intervention participant). The questionnaire (designed specifically for this study) will include questions on:
- How comfortable the staff felt using the intervention (affective attitude);
- How much effort it took to incorporate into care duties (burden);
- whether it reduced stress or thought to have helped behaviours (perceived effectiveness);
- whether it interfered with other care priorities (opportunity costs); and
- whether it was an acceptable intervention.
Timepoint [2] 335047 0
At the conclusion of each participant's admission/intervention period.
The study will run for 6 months.
Secondary outcome [1] 422857 0
Change in severity of delirium, assessed using the Delirium Rating Scale-Revised-98 (DRS-R-98)
Timepoint [1] 422857 0
Delirium presence will be screened for in each participant following recruitment, using the 4AT.
If present, DRS-R-98 will be recorded upon recruitment, then at least twice a week for the duration of their admission/intervention by the research team in collaboration with nursing and/or medical staff caring for the participant.
The duration for which each participant undergoes intervention will vary depending on their illness and hospital length of stay.
The study will run for 6 months.
Secondary outcome [2] 422858 0
Change in psychotropic medication use, assessed via audit of electronic medical record.
Timepoint [2] 422858 0
Psychotropic medication use will be recorded upon recruitment, then at least twice a week for the duration of their admission/intervention by the research team.
Secondary outcome [3] 422859 0
Change in critical incidents eg. code blacks as assessed via audit of electronic medical record.
Timepoint [3] 422859 0
The number of critical incidents will be recorded at the end of the admission/intervention period for each participant, after an audit of the electronic medical record for the intervention period.
Secondary outcome [4] 422860 0
Change in perceived caregiver stress. This will be assessed using the Staff questionnaires (as outlined in Primary endpoint 2 and designed specifically for this study) completed by a staff participant who has administered the intervention (one questionnaire collected for each study intervention participant). This includes a question on:
- whether it reduced caregiver stress (perceived effectiveness).
Timepoint [4] 422860 0
The questionnaire will be collected from staff participants at the end of the admission/intervention period (for each study intervention participant).
Secondary outcome [5] 422861 0
Change in hospital length of stay, assessed via audit of electronic medical record.
Timepoint [5] 422861 0
Upon discharge from hospital.

Eligibility
Key inclusion criteria
• Patients aged greater than or equal to 65 years admitted under a geriatrician to the Aged Care acute or subacute ward;
• Diagnosis of all-cause dementia (new or pre-existing);
• Presence of neuropsychiatric symptoms of dementia +/- delirium; and
• Appropriate written consent from the patient and/or Person Responsible if the patient does not have decisional capacity to consent to clinical research.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Disturbed behaviour due to primary psychiatric illness (not dementia).
• Unable to obtain written consent from patient or Person Responsible.
• Unable to obtain phone consent from patient or Person Responsible for historical control group.
• Unable to obtain written consent from Staff participant.

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
Other
Other design features
A Historical control group will be used to match to the intervention group.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample population of 40 for the intervention group was considered a realistic enrolment target for a 6 month period. This was considered a sufficient period to demonstrate feasibility of the intervention.
Taking into account an expected participation rate of 90% and attrition rate of 5%, up to 48 patients may need to be approached ie. 48 x 0.9= 43.2 and 43 x 0.95= 40.85 (40 patients).

A historical control group of 40 was considered a realistic target over the period November 2022- March 2023 ie. a recent time frame and during which sufficient NPI-Q data would be available.
Taking into account an expected participation rate of 95%, up to 43 patients may need to be contacted ie. 43 x 0.95= 40.85 (40 patients).

Statistical analysis will be conducted using IBM SPSS Statistics software.
Quantitative
Baseline characteristics, reason for admission, dementia diagnoses, NPI-Q results, psychotropic medication usage (type and dosage), critical incidents (eg. Code Blacks, falls) and hospital Length of Stay (LOS) will be collected for the intervention group and historical control group for comparison.
The historical control group will comprise recently admitted patients of similar characteristics.
A mixed effects model will be used to compare between the intervention and control groups for BPSD (presence/absence, total number of symptoms, severity of the symptoms, and associated distress); psychotropic medication usage (type and dosage), number of critical incidents (eg. Code Blacks, falls) and average hospital Length of Stay (LOS).
Effect of the intervention based on duration/frequency of usage (eg. number of sessions per week; hours used per day) may be examined though large variability may limit detailed analysis.
Effect of the intervention between subtypes and severity of dementia will also be examined though small numbers may limit the power of observations.
Effect of the intervention on delirium severity in the intervention group, where present, will also be described though small numbers may limit the power of observations and temporal bias may act as a confounder.
Qualitative
Feasibility (and acceptability) of incorporating the intervention into Standard care will be described using the Staff Participant and Patient Participant/Person Responsible questionnaires.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
22/06/2023
Date of last participant enrolment
Anticipated
31/08/2024
Actual
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
91
Accrual to date
39
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 24891 0
Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 40541 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 314051 0
Charities/Societies/Foundations
Name [1] 314051 0
Prince of Wales Hospital Foundation
Country [1] 314051 0
Australia
Primary sponsor type
Government body
Name
South Eastern Sydney Local Health District
Address
District Executive Unit, Level4
The Sutherland Hospital & Community Health Service
Cnr The Kingsway & Kareena Road
Caringbah
NSW 2229
Country
Australia
Secondary sponsor category [1] 315956 0
None
Name [1] 315956 0
Address [1] 315956 0
Country [1] 315956 0
Other collaborator category [1] 282699 0
Commercial sector/Industry
Name [1] 282699 0
Music Health PTY LTD
Address [1] 282699 0
Level 2, 11-17 York Street Wynyard NSW 2000
Country [1] 282699 0
Australia
Other collaborator category [2] 282700 0
Other Collaborative groups
Name [2] 282700 0
Neuroscience Research Australia
Address [2] 282700 0
U 1 139 BARKER Street,
RANDWICK New South Wales 2031
Country [2] 282700 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313187 0
South Eastern Sydney Local Health District HREC
Ethics committee address [1] 313187 0
Ethics committee country [1] 313187 0
Australia
Date submitted for ethics approval [1] 313187 0
07/03/2023
Approval date [1] 313187 0
30/03/2023
Ethics approval number [1] 313187 0
2023/ETH00271

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

Contacts
Principal investigator
Name 127282 0
Dr Thi Yen Hill
Address 127282 0
Prince of Wales Hospital
Dept. of Aged care
Edmund Blackett Building
Barker St, Randwick NSW 2031
Country 127282 0
Australia
Phone 127282 0
+61293824252
Fax 127282 0
Email 127282 0
[email protected]
Contact person for public queries
Name 127283 0
Thi Yen Hill
Address 127283 0
Prince of Wales Hospital
Dept. of Aged care
Edmund Blackett Building
Barker St, Randwick NSW 2031
Country 127283 0
Australia
Phone 127283 0
+61293824252
Fax 127283 0
Email 127283 0
[email protected]
Contact person for scientific queries
Name 127284 0
Thi Yen Hill
Address 127284 0
Prince of Wales Hospital
Dept. of Aged care
Edmund Blackett Building
Barker St, Randwick NSW 2031
Country 127284 0
Australia
Phone 127284 0
+61293824252
Fax 127284 0
Email 127284 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?
Individual participant data underlying published results only and after de-identification.
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
Only researchers who provide a methodologically sound proposal.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Access subject to approvals by Principal Investigator (Dr Thi Yen Hill. [email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19418Study protocol  [email protected] 386056-(Uploaded-17-06-2023-10-55-07)-Study-related document.docx



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.