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Music Interventions for Dementia and Depression in Elderly Care (MIDDEL)

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ClinicalTrials.gov Identifier: NCT03496675
Recruitment Status : Recruiting
First Posted : April 12, 2018
Last Update Posted : September 9, 2019
Sponsor:
Collaborator:
University of Melbourne
Information provided by (Responsible Party):
NORCE Norwegian Research Centre AS

Tracking Information
First Submitted Date  ICMJE March 6, 2018
First Posted Date  ICMJE April 12, 2018
Last Update Posted Date September 9, 2019
Actual Study Start Date  ICMJE July 18, 2018
Estimated Primary Completion Date April 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2018)
Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 6 months ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2019)
  • Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: up to 24 months ]
    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.
  • Clinical Dementia Rating (CDR) [ Time Frame: 12 months ]
    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.
  • Neuropsychiatric Inventory - Questionnaire (NPI-Q): severity [ Time Frame: 12 months ]
    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.
  • Neuropsychiatric Inventory - Questionnaire (NPI-Q): distress [ Time Frame: 12 months ]
    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.
  • EuroQol (EQ-5D) [ Time Frame: 12 months ]
    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.
  • Quality of Life in Alzheimer´s Dementia (QOL-AD) [ Time Frame: 12 months ]
    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.
  • All-cause mortality (time to death) [ Time Frame: up 24 months ]
    Data on participant deaths will be collected from care staff on a monthly basis.
  • Any increase in medication use (binary, yes/no) [ Time Frame: 12 months ]
    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.
  • Costs [ Time Frame: 12 months ]
    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.
  • Any adverse event [Safety] [ Time Frame: 12 months ]
    All types of adverse events and serious adverse events (e.g. unexpected worsening of symptoms), whether related or unrelated to the interventions, are reported.
  • Professional Care Team Burden Scale [ Time Frame: 12 months ]
    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.
  • Days on sick leave of care staff [ Time Frame: 12 months ]
    (as recorded monthly by the employer)
Original Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2018)
  • Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: up to 24 months ]
    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.
  • Clinical Dementia Rating (CDR) [ Time Frame: 12 months ]
    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).
  • Neuropsychiatric Inventory - Questionnaire (NPI-Q): severity [ Time Frame: 12 months ]
    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.
  • Neuropsychiatric Inventory - Questionnaire (NPI-Q): distress [ Time Frame: 12 months ]
    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.
  • EuroQol (EQ-5D) [ Time Frame: 12 months ]
    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.
  • Quality of Life in Alzheimer´s Dementia (QOL-AD) [ Time Frame: 12 months ]
    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.
  • All-cause mortality (time to death) [ Time Frame: up 24 months ]
    Data on participant deaths will be collected from care staff on a monthly basis.
  • Any increase in medication use (binary, yes/no) [ Time Frame: 12 months ]
    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.
  • Costs [ Time Frame: 12 months ]
    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.
  • Any adverse event [Safety] [ Time Frame: 12 months ]
    All types of adverse events and serious adverse events (e.g. unexpected worsening of symptoms), whether related or unrelated to the interventions, are reported.
  • Professional Care Team Burden Scale [ Time Frame: 12 months ]
    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.
  • Days on sick leave of care staff [ Time Frame: 12 months ]
    (as recorded monthly by the employer)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Music Interventions for Dementia and Depression in Elderly Care
Official Title  ICMJE Music Interventions for Dementia and Depression in Elderly Care: International Cluster-randomised Controlled Trial
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.
Detailed Description

Dementia and depression are highly prevalent and comorbid conditions in older adults and are associated with individual distress, substantial carer burden, and high societal costs.

Music interventions represent a highly promising type of non-pharmacological interventions for both dementia and depression in older adults. They are widely used, but have yet to be rigorously tested in large trials.

The MIDDEL trial is the largest trial of music interventions to date, and the first to compare different music-based interventions - group music therapy (GMT), and recreational choir singing (RCS) - alone and in combination across countries.

MIDDEL is designed as a large, pragmatic, international cluster-randomised controlled trial with a 2x2 factorial design that will compare the effects of GMT, RCS, both, or neither, for care home residents aged 65 years or older with dementia and depressive symptoms.

Study sites will be located in Australia and in six European countries, and a total of 100 care home units will be randomised to one of the four study conditions.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
Blinding of assessors will be ensured by using assessors who do not participate in the daily care of each unit. Assessors will also remind participants not to reveal the unit's allocation to them. At the time of the last assessment, success of blinding will be verified by asking assessors whether they inadvertently discovered the unit's allocation. Intervention providers and study participants (PLWD and staff) cannot be blinded due to the nature of the interventions. However, efforts will be made to ensure that no differential expectations are created and equipoise is maintained (e.g., by careful wording of the patient information and consent form).
Primary Purpose: Treatment
Condition  ICMJE
  • Dementia
  • Depression
Intervention  ICMJE
  • 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: Standard care
    May include pharmacological and non-pharmacological interventions as locally available
Study Arms  ICMJE
  • Standard care
    Participants receive standard care as locally available. The components of standard care are recorded.
    Intervention: Other: Standard care
  • 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).

    Interventions:
    • Behavioral: Group Music Therapy
    • Other: Standard care
  • 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).

    Interventions:
    • Behavioral: Recreational Choir Singing
    • Other: Standard care
  • 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.
    Interventions:
    • Behavioral: Group Music Therapy
    • Behavioral: Recreational Choir Singing
    • Other: Standard care
Publications * Gold C, Eickholt J, Assmus J, Stige B, Wake JD, Baker FA, Tamplin J, Clark I, Lee YC, Jacobsen SL, Ridder HMO, Kreutz G, Muthesius D, Wosch T, Ceccato E, Raglio A, Ruggeri M, Vink A, Zuidema S, Odell-Miller H, Orrell M, Schneider J, Kubiak C, Romeo R, Geretsegger M. Music Interventions for Dementia and Depression in ELderly care (MIDDEL): protocol and statistical analysis plan for a multinational cluster-randomised trial. BMJ Open. 2019 Mar 30;9(3):e023436. doi: 10.1136/bmjopen-2018-023436.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 5, 2018)
1000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2024
Estimated Primary Completion Date April 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Monika Geretsegger, PhD (+47) 46928297 monika.geretsegger@norceresearch.no
Contact: Christian Gold, PhD (+47) 46928297 christian.gold@norceresearch.no
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03496675
Other Study ID Numbers  ICMJE MIDDEL
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: 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 Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data will become available upon publication of the primary outcome.
Access Criteria: De-identified IPD will be publicly available at the Norwegian Centre for Research Data (http://www.nsd.uib.no/nsd/english/index.html).
Responsible Party NORCE Norwegian Research Centre AS
Study Sponsor  ICMJE NORCE Norwegian Research Centre AS
Collaborators  ICMJE University of Melbourne
Investigators  ICMJE
Principal Investigator: Christian Gold, PhD GAMUT, NORCE Norwegian Research Centre, Bergen, Norway
PRS Account NORCE Norwegian Research Centre AS
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP