Music Interventions for Dementia and Depression in ELderly care (MIDDEL): protocol and statistical analysis plan for a multinational cluster-randomised trial
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
BMJ open · 27 citations
How it was studied
- Design
- Randomized controlled trial (classified by our AI screen)
- Studied in
- People
- Main outcome
- Health markers and function
Who paid for it
- Funding
- Independent funding
- University or hospital
- Universitair Medisch Centrum Groningen
- Government
- Medical Research Council
- Government
- National Health and Medical Research Council
- University or hospital
- NORCE basic internal funding
- Grants
- National Health and Medical Research Council (1137853)
Based on 4 listed funder(s).
Publication
- Published
- 2019-03-01 · BMJ Open · vol. 9 · issue 3 · p. e023436
- Publisher
- BMJ
- Cited
- 76 citations · more than 99% of similar papers · 10.6× the field average
- Impact
- Top 10% most cited in its field
- References
- 79 works
- Access
- Open access (journal) · CC-BY-NC
- Research areas
- Music Therapy and Health · Dementia and Cognitive Impairment Research · Health, psychology, and well-being
- Keywords
- Medicine, Dementia, Protocol (science), Depression (economics), Psychological intervention, Multinational corporation, Cluster (spacecraft), Randomized controlled trial, Family medicine, Psychiatry, Gerontology, Alternative medicine, Nursing, Surgery
- MeSH
- humans, dementia, music therapy, geriatric assessment, cluster analysis, depression, quality of life, aged, homes for the aged, nursing homes, multicenter studies as topic, randomized controlled trials as topic, recreation therapy, singing, pragmatic clinical trials as topic
25 authors
From NO, DE, AU, DK, IT, US, ES, NL, AT, GB, FR
- Christian Gold · correspondingNORCE Research AS
- Jasmin EickholtTechnical University of Applied Sciences Würzburg-Schweinfurt
- Jörg AßmusNORCE Research AS
- Brynjulf StigeNORCE Research AS
- Jo Dugstad WakeNORCE Research AS
- Felicity Anne BakerThe University of Melbourne
Abstract
Introduction
In older adults, dementia and depression are associated with individual distress and high societal costs. Music interventions such as group music therapy (GMT) and recreational choir singing (RCS) have shown promising effects, but their comparative effectiveness across clinical subgroups is unknown. This trial aims to determine effectiveness of GMT, RCS and their combination for care home residents and to examine heterogeneity of treatment effects across subgroups.
Methods and analysis
This large, pragmatic, multinational cluster-randomised controlled trial with a 2×2 factorial design will compare the effects of GMT, RCS, both or neither, for care home residents aged 65 years or older with dementia and depressive symptoms. We will randomise 100 care home units with ≥1000 residents in total across eight countries. Each intervention will be offered for 6 months (3 months 2 times/week followed by 3 months 1 time/week), with extension allowed if locally available. The primary outcome will be the change in the Montgomery-Åsberg Depression Rating Scale score at 6 months. Secondary outcomes will include depressive symptoms, cognitive functioning, neuropsychiatric symptoms, psychotropic drug use, caregiver burden, quality of life, mortality and costs over at least 12 months. The study has 90% power to detect main effects and is also powered to determine interaction effects with gender, severity and socioeconomic status.
Ethics and dissemination
Ethical approval has been obtained for one country and will be obtained for all countries. Results will be presented at national and international conferences and published in scientific journals.
Trial registration numbers
NCT03496675; Pre-results, ACTRN12618000156280.
Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY-NC).
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