Akademik Veri Yönetim Sistemi
Diğer Uluslararası Fon Programları, 2021 - 2024
Dementia and depression are highly prevalent and comorbid conditions in older adults and are associated with individual distress, substantial burden for care providers, 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 two different approaches – 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 compares the effects of GMT, RCS, both, or neither, for care home residents aged 65 years or older with dementia and depressive symptoms.
Study sites are located in Australia and in five European countries, and a total of 100 care home units are to be randomised to one of the four study conditions.
Core outcome sets of depressive symptoms, cognitive functioning, neuropsychiatric symptoms, quality of life, medication use, caregiver burden and costs will be assessed at month 3, 6 and 12. The primary outcome will be the change in residents’ scores on the Montgomery-Åsberg Depression Rating Scale at 6 months. Cost-effectiveness will be assessed from a care sector and a societal perspective. The study is powered to detect main effects as well as interaction effects with dementia severity, gender, and socio-economic status.
As part of this study, internationally applicable guidelines based on an international consensus have been defined for both interventions. They will be further developed during the trial through process evaluation to improve both interventions.