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 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (clasificado por nuestro filtro de IA)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Universidad u hospital
- Universitair Medisch Centrum Groningen
- Gobierno
- Medical Research Council
- Gobierno
- National Health and Medical Research Council
- Universidad u hospital
- NORCE basic internal funding
- Subvenciones
- National Health and Medical Research Council (1137853)
Según 4 financiadores declarados.
Publicación
- Publicado
- 2019-03-01 · BMJ Open · vol. 9 · número 3 · pág. e023436
- Editorial
- BMJ
- Citado
- 76 citas · más que el 99% de estudios similares · 10.6× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 79 trabajos
- Acceso
- Acceso abierto (revista) · CC-BY-NC
- Áreas de investigación
- Music Therapy and Health · Dementia and Cognitive Impairment Research · Health, psychology, and well-being
- Palabras clave
- 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 autores
- Christian Gold🇳🇴 · autor de correspondenciaNORCE Research AS
- Jasmin Eickholt🇩🇪Technical University of Applied Sciences Würzburg-Schweinfurt
- Jörg Aßmus🇳🇴NORCE Research AS
- Brynjulf Stige🇳🇴NORCE Research AS
- Jo Dugstad Wake🇳🇴NORCE Research AS
- Felicity Anne Baker🇦🇺The University of Melbourne
- Jeanette Tamplin🇦🇺The University of Melbourne
- Imogen Nicola Clark🇦🇺The University of Melbourne
- Young-Eun Claire Lee🇦🇺The University of Melbourne
- Stine Lindahl Jacobsen🇩🇰Aalborg University
- Hanne Mette Ochsner Ridder🇩🇰Aalborg University
- Gunter Kreutz🇩🇪Carl von Ossietzky Universität Oldenburg
- Dorothea Muthesius🇩🇪Berlin University of the Arts
- Thomas Wosch🇩🇪Technical University of Applied Sciences Würzburg-Schweinfurt
- Enrico Ceccato🇮🇹AULSS 2 Marca Trevigiana; Azienda ULSS 8 Berica
- Alfredo Raglio🇺🇸🇮🇹Perfect Harmony Health; Istituti Clinici Scientifici Maugeri
- Mirella Ruggeri🇮🇹🇪🇸University of Verona; Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública
- Annemieke C. Vink🇳🇱🇺🇸🇦🇹University Medical Center Groningen; University of Groningen; ArtEZ University of the Arts; University of the Arts; University of Music and Performing Arts Graz; Perfect Harmony Health
- Sytse Ulbe Zuidema🇳🇱University Medical Center Groningen; University of Groningen
- Helen Odell‐Miller🇺🇸🇬🇧Perfect Harmony Health; Anglia Ruskin University
- Martin William Orrell🇬🇧University of Nottingham; Institute of Mental Health
- Justine M. Schneider🇬🇧University of Nottingham
- Christine Kubiak🇫🇷European Clinical Research Infrastructure Network
- Renée Romeo🇺🇸🇬🇧The King's College; King's College London
- Monika Geretsegger🇳🇴NORCE Research AS
Resumen
El texto original del estudio, en el idioma en que se publicó.
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.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY-NC).
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