Music Interventions for Dementia and Depression in Elderly Care: International Cluster-randomised Controlled Trial
- Conditions
- Alzheimer10012272DementiaDepressedDepression
- Registration Number
- NL-OMON49117
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 160
Inclusion Criteria
65 years or older nursing home resident
a dementia diagnosis
(mild) depressive symptoms
Exclusion Criteria
a Parkinson's diagnosis
a schizophrenia diagnosis
severe hearing impairment
receives music therapy on indication or receives music intervention(s) with a
therapeutic goal
Exclusion criteria for the exploratory substudy:
advanced or severe dementia (CDR > 2)
swallowing difficulties
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome is the level of depression, which will be evaluated at all<br /><br>time points (primary time point: 6 months) using the total score of the<br /><br>Montgomery-Åsberg Depression Rating Scale (MADRS). Outcomes will be assessed at<br /><br>baseline and 3, 6, and 12 months after randomisation.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes will cover cognitive ability (SIB-8; CDR); agitation<br /><br>(NPI-Q); medication use (section of a tailored version of the CSSRI); generic<br /><br>quality of life (EQ-5D-5L); disease-specific quality of life (QOL-AD); and<br /><br>all-cause mortality (time to death); stress-related biomarkers (cortisol and<br /><br>alpha-amylase); burden on staff (PCTB; days on sick leave). Other outcomes<br /><br>include costs and adverse events (safety), treatment fidelity and quality and<br /><br>sustainability of implementation. Outcomes will be assessed at baseline and 3,<br /><br>6, and 12 months after randomisation..</p><br>