NCT04850807: METRIcAL

Music & MEmory: A Pragmatic TRial for Nursing Home Residents With ALzheimer's Disease (METRIcAL)_part2

Completed NA Results posted Last updated 28 February 2025

What this trial tests

NA trial testing Music & Memory in Dementia in 990 participants. Completed in 8 September 2022.

Timeline

14 May 2021

Primary endpoint
8 September 2022

8 September 2022

Quick facts

Lead sponsor	Brown University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	990
Start date	14 May 2021
Primary completion	8 September 2022
Estimated completion	8 September 2022
Sites	4 locations across United States

Drugs / interventions tested

• Music & Memory

Conditions studied

• Dementia — all drugs for Dementia →

Sponsor

Brown University

Who can join

Eligibility, any sex, with Dementia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Frequency of Agitated and Aggressive Behaviors (Staff Report) Primary · 4-months

The tool used to interview staff about resident behaviors is the Cohen-Mansfield Agitation Inventory (CMAI). Research staff interview nursing staff who know the resident well to ask how frequently 29 agitated/aggressive behaviors occurred in the past week. There are seven response choices for each item, anchored from never (1) to several times per hour (7). Total scores on the CMAI range from 29 to 203, with higher scores representing more frequent agitated/aggressive behaviors. The CMAI is administered at baseline and follow-up.

Group	Value	95% CI
Music & Memory	44.1	± 3.1
Usual Care	47.9	± 3.1

Frequency of Agitated and Aggressive Behaviors (Administrative Data) Secondary · 4 months

The Aggressive Behavior Scale is a 4 item measure describing the frequency of physical behavioral symptoms directed toward others; verbal behavioral symptoms directed toward others; other behavioral symptoms not directed toward others; and behaviors related to resisting necessary care. For each item, frequency in the past week is reported as: behavior not exhibited (0); behavior occurred 1-3 days (1); behavior occurred 4-6 days (2); or behavior occurred daily (3). The Aggressive Behavior Scale ranges from 0 to 12, with higher scores indicating more frequent agitated and/or aggressive behaviors

Group	Value	95% CI
Music & Memory	0.38	± 0.07
Usual Care	0.31	± 0.07

Antipsychotic Use Secondary · 4 months

Any antipsychotic use in the past week, based on Minimum Data Set (standardized assessment of nursing home residents). Comparison of percent with any use will be compared for treatment and control populations. Measure type of mean is chosen based on adjusted percentage with standard errors from a multilevel, difference in difference regression models.

Group	Value	95% CI
Music & Memory	43.6	± 2.3
Usual Care	39.7	± 2.2

Antianxietal Use Secondary · 4 months

Any antianxietal use in the past week , based on Minimum Data Set (standardized assessment of nursing home residents). Comparison of adjusted percent with any use will be compared for treatment and control populations. Measure type of mean is chosen based on adjusted percentage with standard errors from a multilevel, difference in difference regression models.

Group	Value	95% CI
Music & Memory	32.3	± 2.5
Usual Care	33.7	± 2.6

Antidepressant Use Secondary · 4 months

Any antidepressant use in the past week, based on Minimum Data Set (standardized assessment of nursing home residents). Comparison of percent with any use will be compared for treatment and control populations. Measure type of mean is chosen based on adjusted percentage with standard errors from a multilevel, difference in difference regression models.

Group	Value	95% CI
Music & Memory	63.8	± 1.8
Usual Care	68.6	± 1.8

Hypnotic Use Secondary · 4 months

Any hypnotic use in the past week, based on Minimum Data Set (standardized assessment of nursing home residents). Comparison of percent with any use will be compared for treatment and control populations.

Group	Value	95% CI
Music & Memory	1.62
Usual Care	0.95

Depression Secondary · 4 months

The Patient Health Questionnaire is a 9-item screening assessment for depression severity. For each item, respondents indicate the frequency of the symptom in the past 2 weeks using the following choices: never or one day (0); 2-6 days (1); 7-11 days (2); or 12-14 days (3). Total scores range from 0 to 27, with higher scores indicating more frequent depressive symptoms. Average total scores will be compared for treatment and control populations.

Group	Value	95% CI
Music & Memory	2.33	± 0.44
Usual Care	1.61	± 0.47

Sponsor's own description

The purpose of this trial is to test the effects of a personalized music intervention (Music and Memory, Inc.) on agitated and aggressive behaviors for nursing home residents with dementia.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pragmatic Implementation of a Music Intervention in Nursing Homes Before and During COVID-19.
   McCreedy EM, Dewji A, Dionne L, Zhu E, et al · · 2024 · cited 2× · PMID 38036026 · DOI 10.1016/j.jamda.2023.10.021
2. Assessing the representativeness of cluster randomized trials: Evidence from two large pragmatic trials in United States nursing homes.
   Joyce NR, Robertson SE, McCreedy E, Ogarek J, et al · · 2023 · cited 2× · PMID 37493171 · DOI 10.1177/17407745231185055