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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03496675
Ethics application status
Date submitted
6/03/2018
Date registered
12/04/2018
Date last updated
17/09/2020

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
Behaviour - Group Music Therapy
Behaviour - 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.


Behaviour: 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.

Behaviour: 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
Behaviour
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Montgomery-Åsberg Depression Rating Scale (MADRS) - 10-item scale where each item is rated from 0 to 6 ('no abnormality' to 'severe'), yielding a total sum score between 0 and 60, with higher values indicating more severe symptom levels.
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Montgomery-Åsberg Depression Rating Scale (MADRS) - 10-item scale where each item is rated from 0 to 6 ('no abnormality' to 'severe'), yielding a total sum score between 0 and 60, with higher values indicating more severe symptom levels.
Timepoint [1] 0 0
up to 24 months
Secondary outcome [2] 0 0
Clinical Dementia Rating (CDR) - Semi-structured interview with the person living with dementia and an appropriate caregiver/relative; rates impairment across 6 cognitive categories (memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care). The CDR score can range from 0 (normal) to 3 (severe dementia); not used at all sites.
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
Neuropsychiatric Inventory - Questionnaire (NPI-Q): severity - Includes 12 domains where if a symptom is present, its severity (from 1 = mild to 3 = severe) is assessed by a caregiver familiar with the participant's behaviour. Higher scores (sums of all items, range 0 to 36) represent higher severity.
Timepoint [3] 0 0
12 months
Secondary outcome [4] 0 0
Neuropsychiatric Inventory - Questionnaire (NPI-Q): distress - Includes 12 domains where if a symptom is present, the associated distress on caregivers (from 0 = not distressing at all to 5 = extreme or very severe) is assessed by a caregiver familiar with the participant's behaviour. Higher scores (sums of all items, range 0 to 60) represent higher severity.
Timepoint [4] 0 0
12 months
Secondary outcome [5] 0 0
EuroQol (EQ-5D) - Standardized, non-disease-specific instrument for evaluating health-related quality of life, defining health in five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Response categories range from "no problems" to "extreme problems". Scores are derived using a weighted scoring method and can range from 0 = worst possible to 1 = best possible quality of life.
Timepoint [5] 0 0
12 months
Secondary outcome [6] 0 0
Quality of Life in Alzheimer´s Dementia (QOL-AD) - 13-item scale with self-rating and proxy version. Each item ranges from 1 (poor) to 4 (excellent), yielding a total sum score of 13 to 52.
Timepoint [6] 0 0
12 months
Secondary outcome [7] 0 0
All-cause mortality (time to death) - Data on participant deaths will be collected from care staff on a monthly basis.
Timepoint [7] 0 0
up 24 months
Secondary outcome [8] 0 0
Any increase in medication use (binary, yes/no) - Data on type (ATC Codes N065, N06) of medication used and any increase or decrease over time will be collected from care staff using the 'medication profile' section of a tailored version of the Client Socio-Demographic and Service Receipt Inventory (CSSRI), or from available databases.
Timepoint [8] 0 0
12 months
Secondary outcome [9] 0 0
Costs - Total and component costs of the interventions are assessed from a societal perspective, including the cost of the intervention as well as statutory health and social care services used, using a tailored version of the Client Socio-Demographic and Service Receipt Inventory (CSSRI). Total cost per participant will be calculated in Euros.
Timepoint [9] 0 0
12 months
Secondary outcome [10] 0 0
Any adverse event [Safety] - All types of adverse events and serious adverse events (e.g. unexpected worsening of symptoms), whether related or unrelated to the interventions, are reported.
Timepoint [10] 0 0
12 months
Secondary outcome [11] 0 0
Professional Care Team Burden Scale - 10-item scale to obtain ratings of burden from formal care teams working in care homes. Items are scored on a 5-point scale from 0 (strongly disagree) to 4 (strongly agree), yielding a total sum score from 0 to 40, with higher scores indicating higher burden.
Timepoint [11] 0 0
12 months
Secondary outcome [12] 0 0
Days on sick leave of care staff - (as recorded monthly by the employer)
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
Gender
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
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
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] 0 0
The University of Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
3010 - Melbourne

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
This study evaluates the effectiveness of two music-based approaches - group music therapy
and recreational choir singing - for reducing depression symptoms in people living with
dementia. It also examines mechanisms and heterogeneity of treatment effects.
Trial website
https://clinicaltrials.gov/show/NCT03496675
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Christian Gold, 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
Vigdis Sveinsdottir, PhD
Address 0 0
Country 0 0
Phone 0 0
(+47) 56107287
Fax 0 0
Email 0 0
visv@norceresearch.no
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03496675