Trial Outcomes & Findings for Music & MEmory: A Pragmatic TRial for Nursing Home Residents With ALzheimer's Disease_part1 (NCT NCT03821844)

NCT ID: NCT03821844

Last Updated: 2025-02-28

Results Overview

The tool used to interview staff about resident behaviors is the Cohen-Mansfield Agitation Inventory. Research staff interview a nursing staff member who knows the resident well to ask how frequently 29 agitated and/or 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 Cohen-Mansfield Agitation Inventory range from 29 to 203, with higher scores representing more frequent agitated and/or aggressive behaviors. Adjusted mean overall scores will be compared for treatment and control populations.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 1073 participants
• Primary outcome timeframe: 4-months
• Results posted on: 2025-02-28

Participant Flow

Unit of analysis: nursing home

Participant milestones

Measure	Music and Memory Music and Memory is a personalized music program in which nursing home staff provide people with dementia with music playlists tailored to their personal history of music preferences.	Usual Care Usual care for managing agitated and/or aggressive behaviors in the nursing home setting.
Overall Study STARTED	532 27	541 27
Overall Study COMPLETED	483 27	493 27
Overall Study NOT COMPLETED	49 0	48 0

Reasons for withdrawal

Measure	Music and Memory Music and Memory is a personalized music program in which nursing home staff provide people with dementia with music playlists tailored to their personal history of music preferences.	Usual Care Usual care for managing agitated and/or aggressive behaviors in the nursing home setting.
Overall Study Death	37	31
Overall Study Discharged	10	14
Overall Study Not present in facility at followup	2	3

Baseline Characteristics

Music & MEmory: A Pragmatic TRial for Nursing Home Residents With ALzheimer's Disease_part1

Baseline characteristics by cohort

Measure	Music and Memory n=483 Participants Music and Memory is a personalized music program in which nursing home staff provide people with dementia with music playlists tailored to their personal history of music preferences. Music and Memory: Music and Memory is a personalized music program in which caregivers (nursing home staff, family, or others) provide people with dementia with music playlists tailored to their personal history of music preferences.	Usual Care n=493 Participants Usual care for managing agitated and/or aggressive behaviors in the nursing home setting.	Total n=976 Participants Total of all reporting groups
Age, Continuous	79.8 years STANDARD_DEVIATION 12.2 • n=5 Participants	80.8 years STANDARD_DEVIATION 12.3 • n=7 Participants	80.3 years STANDARD_DEVIATION 12.3 • n=5 Participants
Sex: Female, Male Female	327 Participants n=5 Participants	349 Participants n=7 Participants	676 Participants n=5 Participants
Sex: Female, Male Male	156 Participants n=5 Participants	144 Participants n=7 Participants	300 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	124 Participants n=5 Participants	120 Participants n=7 Participants	244 Participants n=5 Participants
Race (NIH/OMB) White	345 Participants n=5 Participants	362 Participants n=7 Participants	707 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment United States	483 Participants n=5 Participants	493 Participants n=7 Participants	976 Participants n=5 Participants
Cognitive function Cognitively intact	52 Participants n=5 Participants	61 Participants n=7 Participants	113 Participants n=5 Participants
Cognitive function Mildly impaired	102 Participants n=5 Participants	104 Participants n=7 Participants	206 Participants n=5 Participants
Cognitive function Moderately impaired	252 Participants n=5 Participants	257 Participants n=7 Participants	509 Participants n=5 Participants
Cognitive function Severely impaired	77 Participants n=5 Participants	71 Participants n=7 Participants	148 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4-months

The tool used to interview staff about resident behaviors is the Cohen-Mansfield Agitation Inventory. Research staff interview a nursing staff member who knows the resident well to ask how frequently 29 agitated and/or 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 Cohen-Mansfield Agitation Inventory range from 29 to 203, with higher scores representing more frequent agitated and/or aggressive behaviors. Adjusted mean overall scores will be compared for treatment and control populations.

Outcome measures

Measure	Music and Memory n=483 Participants Music and Memory is a personalized music program in which nursing home staff provide people with dementia with music playlists tailored to their personal history of music preferences.	Usual Care n=493 Participants Usual care for managing agitated and/or aggressive behaviors in the nursing home setting.
Frequency of Agitated and Aggressive Behaviors (Staff Report)	50.31 score on scale Standard Error 1.35	48.04 score on scale Standard Error 1.35

SECONDARY outcome

Timeframe: 4-months

The tool used to directly observe resident behaviors is the Agitation Behavior Mapping Instrument. Research staff observe residents for short intervals (3 minutes per observation) and record the number of times 14 specific verbally and physically agitated behaviors occurred (up to 10 times per observation). Ordinal outcomes quantify the number of physical and verbal agitated behaviors that occurred during the ABMI observations. The levels of these outcomes are None (0), Some (1 - 3) and Many (4 or more) observed behaviors.

Outcome measures

Measure	Music and Memory n=483 Participants Music and Memory is a personalized music program in which nursing home staff provide people with dementia with music playlists tailored to their personal history of music preferences.	Usual Care n=493 Participants Usual care for managing agitated and/or aggressive behaviors in the nursing home setting.
Frequency of Verbal Agitated and Aggressive Behaviors (Direct Observation) None	0.80 proportion of participants with behavior Interval 0.74 to 0.85	0.80 proportion of participants with behavior Interval 0.74 to 0.85
Frequency of Verbal Agitated and Aggressive Behaviors (Direct Observation) Some	0.13 proportion of participants with behavior Interval 0.09 to 0.17	0.13 proportion of participants with behavior Interval 0.1 to 0.17
Frequency of Verbal Agitated and Aggressive Behaviors (Direct Observation) Many	0.08 proportion of participants with behavior Interval 0.06 to 0.1	0.07 proportion of participants with behavior Interval 0.03 to 0.09

SECONDARY outcome

Timeframe: 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. Mean total scores will be compared for treatment and control populations.

Outcome measures

Measure	Music and Memory n=483 Participants Music and Memory is a personalized music program in which nursing home staff provide people with dementia with music playlists tailored to their personal history of music preferences.	Usual Care n=493 Participants Usual care for managing agitated and/or aggressive behaviors in the nursing home setting.
Frequency of Agitated and Aggressive Behaviors (Administrative Data)	0.42 score on a scale Standard Error 0.08	0.40 score on a scale Standard Error 0.08

SECONDARY outcome

Timeframe: 4-months

Any antipsychotic use in the past week, based on Minimum Data Set (standardized assessment of nursing home residents). Measure type of mean is chosen based on adjusted percentage with standard errors from a multilevel, difference in difference regression models.

Outcome measures

Measure	Music and Memory n=483 Participants Music and Memory is a personalized music program in which nursing home staff provide people with dementia with music playlists tailored to their personal history of music preferences.	Usual Care n=493 Participants Usual care for managing agitated and/or aggressive behaviors in the nursing home setting.
Antipsychotic Use	26.2 adjusted percentage of participants Standard Error 1.4	29.6 adjusted percentage of participants Standard Error 1.3

SECONDARY outcome

Timeframe: 4-months

Any antianxietal use in the past week, based on Minimum Data Set (standardized assessment of nursing home residents). Measure type of mean is chosen based on adjusted percentage with standard errors from a multilevel, difference in difference regression models.

Outcome measures

Measure	Music and Memory n=483 Participants Music and Memory is a personalized music program in which nursing home staff provide people with dementia with music playlists tailored to their personal history of music preferences.	Usual Care n=493 Participants Usual care for managing agitated and/or aggressive behaviors in the nursing home setting.
Antianxietal Use	20.8 adjusted percentage of participants Standard Error 1.5	24.3 adjusted percentage of participants Standard Error 1.7

SECONDARY outcome

Timeframe: 4-months

Any antidepressant use in the past week and days of use in the past week, based on Minimum Data Set (standardized assessment of nursing home residents). Measure type of mean is chosen based on adjusted percentage with standard errors from a multilevel, difference in difference regression models.

Outcome measures

Measure	Music and Memory n=483 Participants Music and Memory is a personalized music program in which nursing home staff provide people with dementia with music playlists tailored to their personal history of music preferences.	Usual Care n=493 Participants Usual care for managing agitated and/or aggressive behaviors in the nursing home setting.
Antidepressant Use	57.5 adjusted percentage of participants Standard Error 1.5	58.8 adjusted percentage of participants Standard Error 1.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Music and Memory n=483 Participants Music and Memory is a personalized music program in which nursing home staff provide people with dementia with music playlists tailored to their personal history of music preferences.	Usual Care n=493 Participants Usual care for managing agitated and/or aggressive behaviors in the nursing home setting.
Hypnotic Use	0.83 unadjusted percentage of participants	1.22 unadjusted percentage of participants

SECONDARY outcome

Timeframe: 4-months

Population: Participants dropped from analysis if missing PHQ-9 score at baseline or followup

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.

Outcome measures

Measure	Music and Memory n=469 Participants Music and Memory is a personalized music program in which nursing home staff provide people with dementia with music playlists tailored to their personal history of music preferences.	Usual Care n=479 Participants Usual care for managing agitated and/or aggressive behaviors in the nursing home setting.
Depression	2.09 score on a scale Standard Error 0.33	2.30 score on a scale Standard Error 0.33

SECONDARY outcome

Timeframe: 4-months

The tool used to directly observe resident behaviors is the Agitation Behavior Mapping Instrument. Research staff observe residents for short intervals (3 minutes per observation) and record the number of times 14 specific verbally and physically agitated behaviors occurred (up to 10 times per observation). We report the proportion of participants with no behaviors, some behaviors (1-3 ), many behaviors (4+)

Outcome measures

Measure	Music and Memory n=483 Participants Music and Memory is a personalized music program in which nursing home staff provide people with dementia with music playlists tailored to their personal history of music preferences.	Usual Care n=493 Participants Usual care for managing agitated and/or aggressive behaviors in the nursing home setting.
Frequency of Physical Agitated and Aggressive Behaviors (Direct Observation) None	0.85 proportion of participants with behavior Interval 0.8 to 0.9	0.90 proportion of participants with behavior Interval 0.85 to 0.94
Frequency of Physical Agitated and Aggressive Behaviors (Direct Observation) Some	0.12 proportion of participants with behavior Interval 0.08 to 0.17	0.09 proportion of participants with behavior Interval 0.06 to 0.13
Frequency of Physical Agitated and Aggressive Behaviors (Direct Observation) Many	0.03 proportion of participants with behavior Interval 0.02 to 0.04	0.01 proportion of participants with behavior Interval 0.01 to 0.02

SECONDARY outcome

Timeframe: 4-months

The Observed Emotion Rating Scale is completed by a trained observer to document duration of five observed emotional states (pleasure, anger, anxiety / fear, sadness, and general alertness) during short observations (3 minutes per observation). For each emotional state, the researcher indicates whether or not the emotion was observed: never (1); less than 16 seconds (2); 16-59 seconds (3); 1-2 minutes (4); or 3+ minutes (5). Total scores range from 5 to 25, with higher scores indicating greater duration of observed emotion. We report the proportion of participants with any observed emotion during the structured observations after four months of follow-up.

Outcome measures

Measure	Music and Memory n=483 Participants Music and Memory is a personalized music program in which nursing home staff provide people with dementia with music playlists tailored to their personal history of music preferences.	Usual Care n=493 Participants Usual care for managing agitated and/or aggressive behaviors in the nursing home setting.
Observed Pleasure	0.36 proportion of participants with behavior Interval 0.3 to 0.43	0.29 proportion of participants with behavior Interval 0.24 to 0.35

SECONDARY outcome

Timeframe: 4-months

The Observed Emotion Rating Scale is completed by a trained observer to document duration of five observed emotional states (pleasure, anger, anxiety / fear, sadness, and general alertness) during short observations (3 minutes per observation). For each emotional state, the researcher indicates whether or not the emotion was observed: never (1); less than 16 seconds (2); 16-59 seconds (3); 1-2 minutes (4); or 3+ minutes (5). Total scores range from 5 to 25, with higher scores indicating greater duration of observed emotion. Average observed emotion scores will be compared for treatment and control populations. We report the proportion of participants with any observed anger during observations after four months of followup.

Outcome measures

Measure	Music and Memory n=483 Participants Music and Memory is a personalized music program in which nursing home staff provide people with dementia with music playlists tailored to their personal history of music preferences.	Usual Care n=493 Participants Usual care for managing agitated and/or aggressive behaviors in the nursing home setting.
Observed Anger	0.04 proportion of participants with emotion Interval 0.03 to 0.06	0.03 proportion of participants with emotion Interval 0.02 to 0.04

SECONDARY outcome

Timeframe: 4-months

The Observed Emotion Rating Scale is completed by a trained observer to document duration of five observed emotional states (pleasure, anger, anxiety / fear, sadness, and general alertness) during short observations (3 minutes per observation). For each emotional state, the researcher indicates whether or not the emotion was observed: never (1); less than 16 seconds (2); 16-59 seconds (3); 1-2 minutes (4); or 3+ minutes (5). Total scores range from 5 to 25, with higher scores indicating greater duration of observed emotion. Average observed emotion scores will be compared for treatment and control populations. We report the proportion of participants any sadness observed during structured observations after four months of follow-up

Outcome measures

Measure	Music and Memory n=483 Participants Music and Memory is a personalized music program in which nursing home staff provide people with dementia with music playlists tailored to their personal history of music preferences.	Usual Care n=493 Participants Usual care for managing agitated and/or aggressive behaviors in the nursing home setting.
Observed Sadness	0.07 proportion of participants with emotion Interval 0.05 to 0.11	0.06 proportion of participants with emotion Interval 0.04 to 0.1

SECONDARY outcome

Timeframe: 4-months

The Observed Emotion Rating Scale is completed by a trained observer to document duration of five observed emotional states (pleasure, anger, anxiety / fear, sadness, and general alertness) during short observations (3 minutes per observation). For each emotional state, the researcher indicates whether or not the emotion was observed: never (1); less than 16 seconds (2); 16-59 seconds (3); 1-2 minutes (4); or 3+ minutes (5). Total scores range from 5 to 25, with higher scores indicating greater duration of observed emotion. Average observed emotion scores will be compared for treatment and control populations. We report the proportion of participants with any observed alertness during structured observations after four months of followup

Outcome measures

Measure	Music and Memory n=483 Participants Music and Memory is a personalized music program in which nursing home staff provide people with dementia with music playlists tailored to their personal history of music preferences.	Usual Care n=493 Participants Usual care for managing agitated and/or aggressive behaviors in the nursing home setting.
Observed Alertness	0.78 proportion of participants with emotion Interval 0.74 to 0.82	0.76 proportion of participants with emotion Interval 0.72 to 0.8

SECONDARY outcome

Timeframe: 4-months

The Observed Emotion Rating Scale is completed by a trained observer to document duration of five observed emotional states (pleasure, anger, anxiety / fear, sadness, and general alertness) during short observations (3 minutes per observation). For each emotional state, the researcher indicates whether or not the emotion was observed: never (1); less than 16 seconds (2); 16-59 seconds (3); 1-2 minutes (4); or 3+ minutes (5). Total scores range from 5 to 25, with higher scores indicating greater duration of observed emotion. Average observed emotion scores will be compared for treatment and control populations. We report the proportion of participants with any observed anxiety during structured observations after four months of follow-up

Outcome measures

Measure	Music and Memory n=483 Participants Music and Memory is a personalized music program in which nursing home staff provide people with dementia with music playlists tailored to their personal history of music preferences.	Usual Care n=493 Participants Usual care for managing agitated and/or aggressive behaviors in the nursing home setting.
Observed Anxiety	0.12 proportion of participants with emotion Interval 0.08 to 0.17	0.13 proportion of participants with emotion Interval 0.08 to 0.18

Adverse Events

Music and Memory

Serious events: 0 serious events

Other events: 0 other events

Deaths: 37 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 31 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ellen McCreedy, PhD

Brown University

Phone: 401-863-7345

Email: Ellen_McCreedy@brown.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place