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, music is preloaded on personalized music devices to increase nursing use of the music with residents. Details of the first parallel trial conducted under this funding mechanism are registered under R33AG057451\_part1.\*\* 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 & 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
Sponsors
National Institute on Aging (NIA)
Brown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Masking description
Principal investigator is blinded to allocation 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
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 a dementia diagnosis
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 (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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antipsychotic Use | 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. |
| Antianxietal Use | 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. |
| 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. |
| 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. |
| 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. |
| Antidepressant Use | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Usual care for managing agitated and/or aggressive behaviors in the nursing home setting | 419 |
| 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 | 431 |
| Total | 850 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 50 | 55 |
| Overall Study | Discharged | 17 | 13 |
| Overall Study | Incomplete baseline data | 3 | 2 |
Baseline characteristics
| Characteristic | Total | Music & Memory | Usual Care |
|---|---|---|---|
| Age, Continuous | 79.0 years STANDARD_DEVIATION 12.4 | 78.5 years STANDARD_DEVIATION 12.5 | 79.6 years STANDARD_DEVIATION 12.2 |
| Cognitive function Cognitively intact | 117 Participants | 53 Participants | 64 Participants |
| Cognitive function Mildly impaired | 187 Participants | 92 Participants | 95 Participants |
| Cognitive function Moderately impaired | 453 Participants | 233 Participants | 220 Participants |
| Cognitive function Severely impaired | 93 Participants | 53 Participants | 40 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 190 Participants | 106 Participants | 84 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 23 Participants | 5 Participants | 18 Participants |
| Race (NIH/OMB) White | 629 Participants | 316 Participants | 313 Participants |
| Region of Enrollment United States | 850 participants | 431 participants | 419 participants |
| Sex: Female, Male Female | 563 Participants | 276 Participants | 287 Participants |
| Sex: Female, Male Male | 287 Participants | 155 Participants | 132 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 50 / 489 | 55 / 501 |
| other Total, other adverse events | 0 / 489 | 0 / 501 |
| serious Total, serious adverse events | 0 / 489 | 0 / 501 |
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 (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.
Time frame: 4-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Music & Memory | Frequency of Agitated and Aggressive Behaviors (Staff Report) | 44.1 score on a scale | Standard Error 3.1 |
| Usual Care | Frequency of Agitated and Aggressive Behaviors (Staff Report) | 47.9 score on a scale | Standard Error 3.1 |
p-value: <0.0595% CI: [-6.9, 6]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). 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.
Time frame: 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Music & Memory | Antianxietal Use | 32.3 adjusted percentage of participants | Standard Error 2.5 |
| Usual Care | Antianxietal Use | 33.7 adjusted percentage of participants | Standard Error 2.6 |
p-value: <0.0595% CI: [-8.5, 5.6]Differences-in-Differences regression
Secondary
Antidepressant Use
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.
Time frame: 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Music & Memory | Antidepressant Use | 63.8 adjusted percentage of participants | Standard Error 1.8 |
| Usual Care | Antidepressant Use | 68.6 adjusted percentage of participants | Standard Error 1.8 |
p-value: <0.0595% CI: [-9.8, 0.1]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). 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.
Time frame: 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Music & Memory | Antipsychotic Use | 43.6 adjusted percentage of participants | Standard Error 2.3 |
| Usual Care | Antipsychotic Use | 39.7 adjusted percentage of participants | Standard Error 2.2 |
p-value: <0.0595% CI: [-2.3, 10.2]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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Music & Memory | Depression | 2.33 score on a scale | Standard Error 0.44 |
| Usual Care | Depression | 1.61 score on a scale | Standard Error 0.47 |
p-value: <0.0595% CI: [-1.03, 0.41]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 & Memory | Frequency of Agitated and Aggressive Behaviors (Administrative Data) | 0.38 score on a scale | Standard Error 0.07 |
| Usual Care | Frequency of Agitated and Aggressive Behaviors (Administrative Data) | 0.31 score on a scale | Standard Error 0.07 |
p-value: <0.0595% CI: [-0.06, 0.26]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 & Memory | Hypnotic Use | 1.62 unadjusted percentage of participants |
| Usual Care | Hypnotic Use | 0.95 unadjusted percentage of participants |