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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03496675




Registration number
NCT03496675
Ethics application status
Date submitted
6/03/2018
Date registered
12/04/2018

Titles & IDs
Public title
Music Interventions for Dementia and Depression in Elderly Care
Scientific title
Music Interventions for Dementia and Depression in Elderly Care: International Cluster-randomised Controlled Trial
Secondary ID [1] 0 0
MIDDEL
Universal Trial Number (UTN)
Trial acronym
MIDDEL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 0 0
Depression 0 0
Condition category
Condition code
Neurological 0 0 0 0
Dementias
Neurological 0 0 0 0
Alzheimer's disease
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Group Music Therapy
BEHAVIORAL - Recreational Choir Singing
Other interventions - Standard care

Other: Standard care - Participants receive standard care as locally available. The components of standard care are recorded.

Experimental: Group Music Therapy (GMT) - GMT is provided twice weekly for the first three months, followed by weekly sessions for the next three months, with possible extension after that period as desired and feasible. Sessions are 45 minutes each.

In line with usual practice, and as appropriate in local contexts, residents of a unit allocated to GMT may be divided into smaller groups (e.g. around 5 participants).

Experimental: Recreational Choir Singing (RCS) - RCS is provided twice weekly for the first three months, followed by weekly sessions for the next three months, with possible extension after that period as desired and feasible. Sessions are 45 minutes each.

RCS may be conducted in larger groups (e.g. with all residents of the unit in one group).

Experimental: GMT + RCS - Group Music Therapy and Recreational Choir Singing are both provided twice weekly for the first three months, followed by weekly sessions for the next three months, with possible extension after that period as desired and feasible. Sessions are 45 minutes each.


BEHAVIORAL: Group Music Therapy
The core intention of GMT is to meet the psychosocial needs of each person living with dementia, which in turn is thought to reduce depressive symptoms and anxiety and to stimulate overall social and emotional wellbeing. It includes active, reciprocal music making with the use of singing and musical instruments. GMT is provided by a trained music therapist, highly skilled as a musician, and registered with the appropriate professional association in his or her country.

BEHAVIORAL: Recreational Choir Singing
RCS is intended to foster connectedness in a group, wellbeing, and enjoyment of music making in a group. It includes singing familiar songs and providing a familiar musical environment for participants. RCS is provided by a musician with choir leading skills.

Other interventions: Standard care
May include pharmacological and non-pharmacological interventions as locally available
Intervention code [1] 0 0
BEHAVIORAL
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Montgomery-Åsberg Depression Rating Scale (MADRS)
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Montgomery-Åsberg Depression Rating Scale (MADRS)
Timepoint [1] 0 0
up to 24 months
Secondary outcome [2] 0 0
Clinical Dementia Rating (CDR)
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
Neuropsychiatric Inventory - Questionnaire (NPI-Q): severity
Timepoint [3] 0 0
12 months
Secondary outcome [4] 0 0
Neuropsychiatric Inventory - Questionnaire (NPI-Q): distress
Timepoint [4] 0 0
12 months
Secondary outcome [5] 0 0
EuroQol (EQ-5D)
Timepoint [5] 0 0
12 months
Secondary outcome [6] 0 0
Quality of Life in Alzheimer´s Dementia (QOL-AD)
Timepoint [6] 0 0
12 months
Secondary outcome [7] 0 0
All-cause mortality (time to death)
Timepoint [7] 0 0
up 24 months
Secondary outcome [8] 0 0
Any increase in medication use (binary, yes/no)
Timepoint [8] 0 0
12 months
Secondary outcome [9] 0 0
Costs
Timepoint [9] 0 0
12 months
Secondary outcome [10] 0 0
Any adverse event [Safety]
Timepoint [10] 0 0
12 months
Secondary outcome [11] 0 0
Professional Care Team Burden Scale
Timepoint [11] 0 0
12 months
Secondary outcome [12] 0 0
Days on sick leave of care staff
Timepoint [12] 0 0
12 months

Eligibility
Key inclusion criteria
* resident (full-time, 24h/day) at a participating care home;
* dementia as indicated by a Clinical Dementia Rating score of 0.5 or more and a Mini-Mental State Examination (MMSE) score of 26 or less;
* at least mild depressive symptoms, as indicated by a Montgomery-Åsberg Depression Rating Scale (MADRS) score of at least 8;
* a clinical diagnosis of dementia according to ICD-10 research criteria;
* have given written informed consent (may be assent by proxy for those unable to provide consent themselves).
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* diagnosis of schizophrenia or Parkinson's disease;
* severe hearing-impairment;
* in short-term care;
* unable to tolerate sitting in a chair for the duration of the sessions.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Factorial
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/07/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2024
Actual
Sample size
Target
Accrual to date
Final
1021
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The University of Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
3010 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Oldenburg
Country [2] 0 0
Netherlands
State/province [2] 0 0
Groningen
Country [3] 0 0
Norway
State/province [3] 0 0
Vestland
Country [4] 0 0
Turkey
State/province [4] 0 0
Ankara
Country [5] 0 0
United Kingdom
State/province [5] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Other
Name
NORCE Norwegian Research Centre AS
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Melbourne
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Oldenburg
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
University Medical Center Groningen
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Ankara Haci Bayram Veli University
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
University of Nottingham
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Vigdis Sveinsdottir, PhD
Address 0 0
GAMUT, NORCE Norwegian Research Centre, Bergen, Norway
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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 datasets (participant codes and outcome scores) generated during and/or analysed during the current study will be stored in a publically available repository (NSD - Norwegian Centre for Research Data, http://www.nsd.uib.no/nsd/english/index.html).

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Data will become available upon publication of the primary outcome.
Available to whom?
De-identified IPD will be publicly available at the Norwegian Centre for Research Data (http://www.nsd.uib.no/nsd/english/index.html).
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents



Results not provided in https://clinicaltrials.gov/study/NCT03496675