TY - JOUR
T1 - Music Interventions for Dementia and Depression in ELderly care (MIDDEL)
T2 - Protocol and statistical analysis plan for a multinational cluster-randomised trial
AU - Gold, Christian
AU - Eickholt, Jasmin
AU - Assmus, Jörg
AU - Stige, Brynjulf
AU - Wake, Jo Dugstad
AU - Baker, Felicity Anne
AU - Tamplin, Jeanette
AU - Clark, Imogen
AU - Lee, Young Eun Claire
AU - Jacobsen, Stine Lindahl
AU - Ridder, Hanne Mette Ochsner
AU - Kreutz, Gunter
AU - Muthesius, Dorothea
AU - Wosch, Thomas
AU - Ceccato, Enrico
AU - Raglio, Alfredo
AU - Ruggeri, Mirella
AU - Vink, Annemiek
AU - Zuidema, Sytse
AU - Odell-Miller, Helen
AU - Orrell, Martin
AU - Schneider, Justine
AU - Kubiak, Christine
AU - Romeo, Renee
AU - Geretsegger, Monika
PY - 2019/3/1
Y1 - 2019/3/1
N2 - 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.
AB - 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.
KW - care homes
KW - dementia
KW - depression & mood disorders
KW - music interventions
KW - music therapy
KW - neurology
KW - old age psychiatry
KW - psychiatry
UR - http://www.scopus.com/inward/record.url?scp=85064005676&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2018-023436
DO - 10.1136/bmjopen-2018-023436
M3 - Article
C2 - 30928926
AN - SCOPUS:85064005676
VL - 9
JO - BMJ Open
JF - BMJ Open
IS - 3
M1 - e023436
ER -