Measuring the effects of a personalized music intervention on agitated behaviors among nursing home residents with dementia: design features for cluster-randomized adaptive trial

Abstract

Background Agitated and aggressive behaviors (behaviors) are common in nursing home (NH) residents with dementia. Medications commonly used to manage behaviors have dangerous side effects. NHs are adopting non-pharmacological interventions to manage behaviors, despite a lack of effectiveness evidence and an understanding of optimal implementation strategies. We are conducting an adaptive trial to evaluate the effects of personalized music on behaviors. Adaptive trials may increase efficiency and reduce costs associated with traditional RCTs by learning and making modifications to the trial while it is ongoing. Methods We are conducting two consecutive parallel cluster-randomized trials with 54 NHs in each trial (27 treatment, 27 control). Participating NHs were recruited from 4 corporations which differ in size, ownership structure, geography, and residents’ racial composition. After randomization, there were no significant differences between the NHs randomized to each trial with respect to baseline behaviors, number of eligible residents, degree of cognitive impairment, or antipsychotic use. Agitated behavior frequency is assessed via staff interviews (primary outcome), required nursing staff conducted resident assessments (secondary outcome), and direct observations of residents (secondary outcome). Between the two parallel trials, the adaptive design will be used to test alternative implementation strategies, increasingly enroll residents who are likely to benefit from the intervention, and seamlessly conduct a stage III/IV trial. Discussion This adaptive trial allows investigators to estimate the impact of a popular non-pharmaceutical intervention (personalized music) on residents’ behaviors, under pragmatic, real-world conditions testing two implementation strategies. This design has the potential to reduce the research timeline by improving the likelihood of powered results, increasingly enrolling residents most likely to benefit from intervention, sequentially assessing the effectiveness of implementation strategies in the same trial, and creating a statistical model to reduce the future need for onsite data collection. The design may also increase research equity by enrolling and tailoring the intervention to populations otherwise excluded from research. Our design will inform pragmatic testing of other interventions with limited efficacy evidence but widespread stakeholder adoption because of the real-world need for non-pharmaceutical approaches. {2a} Trial registration ClinicalTrials.govNCT03821844. Registered on January 30, 2019. This trial registration meets the World Health Organization (WHO) minimum standard.

Exploratory study of Google Nest Hubs in the long-term care setting in Manitoba – Canada

“…The most common recreational use of the GNHs was their ability to offer ondemand, personalized music. Researchers have speculated that listening to music may benefit LTC residents with cognitive decline (McCreedy et al, 2021), since early musical memories may be stored in areas of the brain affected during cognitive decline (Groussard et al, 2019). The relaxation response elicited by music (Hernandez-Ruiz et al, 2020), along with the potential to evoke autobiographical memories (Belfi et al, 2022) may help address agitation concerns within this population (McCreedy et al, 2021).…”

“…Researchers have speculated that listening to music may benefit LTC residents with cognitive decline (McCreedy et al, 2021), since early musical memories may be stored in areas of the brain affected during cognitive decline (Groussard et al, 2019). The relaxation response elicited by music (Hernandez-Ruiz et al, 2020), along with the potential to evoke autobiographical memories (Belfi et al, 2022) may help address agitation concerns within this population (McCreedy et al, 2021). That providing personalized music for the residents was so often reported as a natural use of the device suggests that these devices may be pivotal in providing this service.…”

Music Therapy in the Treatment of Dementia: A Review Article

“…Two simultaneous cluster randomized controlled trials are being carried out in this study using an adaptive study design. Three main aspects of the adaptive design are tested: different implementation methods, boosting enrollment of residents for whom the intervention will probably be beneficial, and smoothly running a stage three/four trial [ 21 ]. Although more work is required to take into account the disease's clinical complexity and build stronger evidence capable of addressing rehabilitative techniques, the protocol for the use of music played by the individual to bring back memories of past may represent an initial application of personalized medicine in dementia [ 22 ].…”

Measuring implementation fidelity in a cluster-randomized pragmatic trial: development and use of a quantitative multi-component approach

“…Music & MEmory: A Pragmatic TRial for Nursing Home Residents With Alzheimer's Disease (METRIcAL) was a parallel, cluster-randomized ePCT of M&M. This study was designed as a pilot hybrid type 2 trial [26], which simultaneously evaluates intervention effectiveness and implementation [4,27]. The details of the trial are described elsewhere (Clinicaltrials.gov ID: NCT03821844) [25].…”