Trial Outcomes & Findings for Music & MEmory: A Pragmatic TRial for Nursing Home Residents With ALzheimer's Disease (METRIcAL)_part2 (NCT NCT04850807)
NCT ID: NCT04850807
Last Updated: 2025-02-28
Results Overview
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.
COMPLETED
NA
990 participants
4-months
2025-02-28
Participant Flow
Unit of analysis: nursing home
Participant milestones
| Measure |
Usual Care
Usual care for managing agitated and/or aggressive behaviors in the nursing home setting
|
Music & 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 at early signs of agitation
Music \& 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 at times when behaviors are likely
|
|---|---|---|
|
Overall Study
STARTED
|
489 27
|
501 27
|
|
Overall Study
COMPLETED
|
419 27
|
431 27
|
|
Overall Study
NOT COMPLETED
|
70 0
|
70 0
|
Reasons for withdrawal
| Measure |
Usual Care
Usual care for managing agitated and/or aggressive behaviors in the nursing home setting
|
Music & 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 at early signs of agitation
Music \& 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 at times when behaviors are likely
|
|---|---|---|
|
Overall Study
Death
|
50
|
55
|
|
Overall Study
Discharged
|
17
|
13
|
|
Overall Study
Incomplete baseline data
|
3
|
2
|
Baseline Characteristics
Music & MEmory: A Pragmatic TRial for Nursing Home Residents With ALzheimer's Disease (METRIcAL)_part2
Baseline characteristics by cohort
| Measure |
Usual Care
n=419 Participants
Usual care for managing agitated and/or aggressive behaviors in the nursing home setting
|
Music & Memory
n=431 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 at early signs of agitation
Music \& 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 at times when behaviors are likely
|
Total
n=850 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
79.6 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
78.5 years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
79.0 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
287 Participants
n=5 Participants
|
276 Participants
n=7 Participants
|
563 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
132 Participants
n=5 Participants
|
155 Participants
n=7 Participants
|
287 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
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 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
|
84 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
190 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
313 Participants
n=5 Participants
|
316 Participants
n=7 Participants
|
629 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
18 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
419 participants
n=5 Participants
|
431 participants
n=7 Participants
|
850 participants
n=5 Participants
|
|
Cognitive function
Cognitively intact
|
64 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Cognitive function
Mildly impaired
|
95 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
187 Participants
n=5 Participants
|
|
Cognitive function
Moderately impaired
|
220 Participants
n=5 Participants
|
233 Participants
n=7 Participants
|
453 Participants
n=5 Participants
|
|
Cognitive function
Severely impaired
|
40 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4-monthsThe 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.
Outcome measures
| Measure |
Music & Memory
n=431 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 at early signs of agitation.
|
Usual Care
n=419 Participants
Usual care for managing agitated and/or aggressive behaviors in the nursing home setting
|
|---|---|---|
|
Frequency of Agitated and Aggressive Behaviors (Staff Report)
|
44.1 score on a scale
Standard Error 3.1
|
47.9 score on a scale
Standard Error 3.1
|
SECONDARY outcome
Timeframe: 4 monthsThe 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 & Memory
n=431 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 at early signs of agitation.
|
Usual Care
n=419 Participants
Usual care for managing agitated and/or aggressive behaviors in the nursing home setting
|
|---|---|---|
|
Frequency of Agitated and Aggressive Behaviors (Administrative Data)
|
0.38 score on a scale
Standard Error 0.07
|
0.31 score on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: 4 monthsAny 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.
Outcome measures
| Measure |
Music & Memory
n=431 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 at early signs of agitation.
|
Usual Care
n=419 Participants
Usual care for managing agitated and/or aggressive behaviors in the nursing home setting
|
|---|---|---|
|
Antipsychotic Use
|
43.6 adjusted percentage of participants
Standard Error 2.3
|
39.7 adjusted percentage of participants
Standard Error 2.2
|
SECONDARY outcome
Timeframe: 4 monthsAny 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.
Outcome measures
| Measure |
Music & Memory
n=431 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 at early signs of agitation.
|
Usual Care
n=419 Participants
Usual care for managing agitated and/or aggressive behaviors in the nursing home setting
|
|---|---|---|
|
Antianxietal Use
|
32.3 adjusted percentage of participants
Standard Error 2.5
|
33.7 adjusted percentage of participants
Standard Error 2.6
|
SECONDARY outcome
Timeframe: 4 monthsAny 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.
Outcome measures
| Measure |
Music & Memory
n=431 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 at early signs of agitation.
|
Usual Care
n=419 Participants
Usual care for managing agitated and/or aggressive behaviors in the nursing home setting
|
|---|---|---|
|
Antidepressant Use
|
63.8 adjusted percentage of participants
Standard Error 1.8
|
68.6 adjusted percentage of participants
Standard Error 1.8
|
SECONDARY outcome
Timeframe: 4 monthsAny 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 & Memory
n=431 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 at early signs of agitation.
|
Usual Care
n=419 Participants
Usual care for managing agitated and/or aggressive behaviors in the nursing home setting
|
|---|---|---|
|
Hypnotic Use
|
1.62 unadjusted percentage of participants
|
0.95 unadjusted percentage of participants
|
SECONDARY outcome
Timeframe: 4 monthsThe 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 & Memory
n=431 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 at early signs of agitation.
|
Usual Care
n=419 Participants
Usual care for managing agitated and/or aggressive behaviors in the nursing home setting
|
|---|---|---|
|
Depression
|
2.33 score on a scale
Standard Error 0.44
|
1.61 score on a scale
Standard Error 0.47
|
Adverse Events
Usual Care
Music & Memory
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place