Dementia
Conditions
Brief summary
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.
Detailed description
The purpose of this study is to conduct a parallel, pragmatic, cluster randomized control trial of personalized music (Music and Memory) for nursing home residents with moderate to severe dementia living in 54 nursing homes (27 treatment, 27 control) from 4 nursing home corporations. Music and Memory is a personalized music program that uses portable music players to deliver individualized music to people with dementia at times when agitated behaviors are likely. \*\*This funding mechanism sponsored two parallel trials with different implementation strategies. In this trial, nursing home staff identify the music a resident with dementia may have preferred when s/he was young by asking family members and testing individual songs with the resident. Details of the second parallel trial conducted under this funding mechanism are registered under R33AG057451\_part2.\*\* The aims of this study are: 1. To use a train-the-trainer model to implement the intervention with ongoing monitoring of the program's adoption and acceptance by nursing home residents with dementia; 2. To estimate the impact of Music and Memory on agitated and aggressive behaviors; and 3. To examine factors associated with variation in providers' adherence to the implementation of Music and Memory.
Interventions
BEHAVIORALMusic 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.
Sponsors
Westat
National Institute on Aging (NIA)
Brown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Masking description
The principal investigator is blinded to random assignment of nursing homes to treatment or control conditions
Intervention model description
The investigator's primary outcome (staff report of resident agitated and aggressive behaviors) will be evaluated using a parallel design. Some secondary outcomes will be tested with a stepped wedge design.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
for Nursing Homes: * Owned by partnering health care corporations * Medicare / Medicaid-certified * Have at least 20 eligible residents Inclusion Criteria for Residents in Eligible Nursing Homes * Reside in eligible nursing home for last 90 days * Have advanced dementia, defined by the presence of a dementia diagnosis and moderately or severely impaired daily decision-making
Exclusion criteria
for Nursing Homes: * recent situations that may affect implementation (for example, bad state or federal quality assurance surveys, leadership turnover, or other competing demands) * previous use of Music and Memory
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Agitated and Aggressive Behaviors (Staff Report) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antidepressant Use | 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. |
| Hypnotic Use | 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. |
| Frequency of Verbal Agitated and Aggressive Behaviors (Direct Observation) | 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. |
| Frequency of Agitated and Aggressive Behaviors (Administrative Data) | 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. |
| Antipsychotic Use | 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. |
| Depression | 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. |
| Antianxietal Use | 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. |
| Observed Pleasure | 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. |
| Observed Anger | 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. |
| Observed Sadness | 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 |
| Observed Alertness | 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 |
| Observed Anxiety | 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 |
| Frequency of Physical Agitated and Aggressive Behaviors (Direct Observation) | 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+) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 483 |
| Usual Care Usual care for managing agitated and/or aggressive behaviors in the nursing home setting. | 493 |
| Total | 976 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 37 | 31 |
| Overall Study | Discharged | 10 | 14 |
| Overall Study | Not present in facility at followup | 2 | 3 |
Baseline characteristics
| Characteristic | Usual Care | Total | Music and Memory |
|---|---|---|---|
| Age, Continuous | 80.8 years STANDARD_DEVIATION 12.3 | 80.3 years STANDARD_DEVIATION 12.3 | 79.8 years STANDARD_DEVIATION 12.2 |
| Cognitive function Cognitively intact | 61 Participants | 113 Participants | 52 Participants |
| Cognitive function Mildly impaired | 104 Participants | 206 Participants | 102 Participants |
| Cognitive function Moderately impaired | 257 Participants | 509 Participants | 252 Participants |
| Cognitive function Severely impaired | 71 Participants | 148 Participants | 77 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 120 Participants | 244 Participants | 124 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 18 Participants | 10 Participants |
| Race (NIH/OMB) White | 362 Participants | 707 Participants | 345 Participants |
| Region of Enrollment United States | 493 Participants | 976 Participants | 483 Participants |
| Sex: Female, Male Female | 349 Participants | 676 Participants | 327 Participants |
| Sex: Female, Male Male | 144 Participants | 300 Participants | 156 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 37 / 532 | 31 / 541 |
| other Total, other adverse events | 0 / 532 | 0 / 541 |
| serious Total, serious adverse events | 0 / 532 | 0 / 541 |
Outcome results
Primary
Frequency of Agitated and Aggressive Behaviors (Staff Report)
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.
Time frame: 4-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Music and Memory | Frequency of Agitated and Aggressive Behaviors (Staff Report) | 50.31 score on scale | Standard Error 1.35 |
| Usual Care | Frequency of Agitated and Aggressive Behaviors (Staff Report) | 48.04 score on scale | Standard Error 1.35 |
p-value: <0.0595% CI: [-1.37, 4.03]Differences-in-Differences regression
Secondary
Antianxietal Use
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.
Time frame: 4-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Music and Memory | Antianxietal Use | 20.8 adjusted percentage of participants | Standard Error 1.5 |
| Usual Care | Antianxietal Use | 24.3 adjusted percentage of participants | Standard Error 1.7 |
p-value: <0.0595% CI: [-7.55, 0.06]Differences-in-Differences regression
Secondary
Antidepressant Use
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.
Time frame: 4-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Music and Memory | Antidepressant Use | 57.5 adjusted percentage of participants | Standard Error 1.5 |
| Usual Care | Antidepressant Use | 58.8 adjusted percentage of participants | Standard Error 1.5 |
p-value: <0.0595% CI: [-5.28, 2.76]Differences-in-Differences regression
Secondary
Antipsychotic Use
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.
Time frame: 4-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Music and Memory | Antipsychotic Use | 26.2 adjusted percentage of participants | Standard Error 1.4 |
| Usual Care | Antipsychotic Use | 29.6 adjusted percentage of participants | Standard Error 1.3 |
p-value: <0.0595% CI: [-7.22, 0]Differences-in-Differences regression
Secondary
Depression
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.
Time frame: 4-months
Population: Participants dropped from analysis if missing PHQ-9 score at baseline or followup
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Music and Memory | Depression | 2.09 score on a scale | Standard Error 0.33 |
| Usual Care | Depression | 2.30 score on a scale | Standard Error 0.33 |
p-value: <0.0595% CI: [-1.14, 0.7]Differences-in-Differences regression
Secondary
Frequency of Agitated and Aggressive Behaviors (Administrative Data)
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.
Time frame: 4-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Music and Memory | Frequency of Agitated and Aggressive Behaviors (Administrative Data) | 0.42 score on a scale | Standard Error 0.08 |
| Usual Care | Frequency of Agitated and Aggressive Behaviors (Administrative Data) | 0.40 score on a scale | Standard Error 0.08 |
p-value: <0.0595% CI: [-0.3, 0.08]Differences-in-Differences regression
Secondary
Frequency of Physical Agitated and Aggressive Behaviors (Direct Observation)
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+)
Time frame: 4-months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Music and Memory | Frequency of Physical Agitated and Aggressive Behaviors (Direct Observation) | None | 0.85 proportion of participants with behavior |
| Music and Memory | Frequency of Physical Agitated and Aggressive Behaviors (Direct Observation) | Some | 0.12 proportion of participants with behavior |
| Music and Memory | Frequency of Physical Agitated and Aggressive Behaviors (Direct Observation) | Many | 0.03 proportion of participants with behavior |
| Usual Care | Frequency of Physical Agitated and Aggressive Behaviors (Direct Observation) | None | 0.90 proportion of participants with behavior |
| Usual Care | Frequency of Physical Agitated and Aggressive Behaviors (Direct Observation) | Some | 0.09 proportion of participants with behavior |
| Usual Care | Frequency of Physical Agitated and Aggressive Behaviors (Direct Observation) | Many | 0.01 proportion of participants with behavior |
p-value: <0.0595% CI: [-0.03, 0.02]Differences-in-Differences regression
Secondary
Frequency of Verbal Agitated and Aggressive Behaviors (Direct Observation)
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.
Time frame: 4-months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Music and Memory | Frequency of Verbal Agitated and Aggressive Behaviors (Direct Observation) | None | 0.80 proportion of participants with behavior |
| Music and Memory | Frequency of Verbal Agitated and Aggressive Behaviors (Direct Observation) | Some | 0.13 proportion of participants with behavior |
| Music and Memory | Frequency of Verbal Agitated and Aggressive Behaviors (Direct Observation) | Many | 0.08 proportion of participants with behavior |
| Usual Care | Frequency of Verbal Agitated and Aggressive Behaviors (Direct Observation) | None | 0.80 proportion of participants with behavior |
| Usual Care | Frequency of Verbal Agitated and Aggressive Behaviors (Direct Observation) | Some | 0.13 proportion of participants with behavior |
| Usual Care | Frequency of Verbal Agitated and Aggressive Behaviors (Direct Observation) | Many | 0.07 proportion of participants with behavior |
p-value: <0.0595% CI: [0.03, 0.09]Differences-in-Differences regression
Secondary
Hypnotic Use
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.
Time frame: 4-months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Music and Memory | Hypnotic Use | 0.83 unadjusted percentage of participants |
| Usual Care | Hypnotic Use | 1.22 unadjusted percentage of participants |
Secondary
Observed Alertness
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
Time frame: 4-months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Music and Memory | Observed Alertness | 0.78 proportion of participants with emotion |
| Usual Care | Observed Alertness | 0.76 proportion of participants with emotion |
p-value: <0.0595% CI: [-0.02, 0.03]Differences-in-Differences regression
Secondary
Observed Anger
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.
Time frame: 4-months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Music and Memory | Observed Anger | 0.04 proportion of participants with emotion |
| Usual Care | Observed Anger | 0.03 proportion of participants with emotion |
p-value: <0.0595% CI: [-0.03, 0.01]Differences-in-Differences regression
Secondary
Observed Anxiety
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
Time frame: 4-months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Music and Memory | Observed Anxiety | 0.12 proportion of participants with emotion |
| Usual Care | Observed Anxiety | 0.13 proportion of participants with emotion |
p-value: <0.0595% CI: [-0.05, 0.01]Differences-in-Differences regression
Secondary
Observed Pleasure
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.
Time frame: 4-months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Music and Memory | Observed Pleasure | 0.36 proportion of participants with behavior |
| Usual Care | Observed Pleasure | 0.29 proportion of participants with behavior |
p-value: <0.0595% CI: [0.02, 0.07]Differences-in-Differences regression
Secondary
Observed Sadness
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
Time frame: 4-months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Music and Memory | Observed Sadness | 0.07 proportion of participants with emotion |
| Usual Care | Observed Sadness | 0.06 proportion of participants with emotion |
p-value: <0.0595% CI: [-0.04, 0.01]Differences-in-Differences regression