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| ID | Type | Description | Link |
|---|---|---|---|
| R33AG057451 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Westat | OTHER |
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Music and Memory | Experimental | 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 | No Intervention | Usual care for managing agitated and/or aggressive behaviors in the nursing home setting. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Music and Memory | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4-months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria for Nursing Homes:
Inclusion Criteria for Residents in Eligible Nursing Homes
Exclusion Criteria for Nursing Homes:
Exclusion Criteria for Residents in Eligible Nursing Homes:
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| Name | Affiliation | Role |
|---|---|---|
| Vincent Mor, PhD | Brown University, School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PruittHealth | Norcross | Georgia | 30093 | United States | ||
| Vetter Senior Living |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40352475 | Derived | Conard RA, Baier RR, Sisti A, Dionne L, McCreedy EM. Resident and Nursing Home Factors Associated With Adherence to a Personalized Music Intervention: Secondary Analyses From Music & MEmory: A Pragmatic TRial for Nursing Home Residents With ALzheimer's Disease (METRIcAL). J Aging Res. 2025 May 2;2025:2679462. doi: 10.1155/jare/2679462. eCollection 2025. | |
| 40243529 | Derived | Weems JA, Wittenberg GF, Baier RR, Reddy A, McCreedy E. Moderators of Adherence Within a Nursing Home Pragmatic Trial of Personalized Music. Gerontologist. 2025 May 10;65(6):gnaf128. doi: 10.1093/geront/gnaf128. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Usual Care | Usual care for managing agitated and/or aggressive behaviors in the nursing home setting. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Error | score on scale | 4-months |
|
8 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ellen McCreedy, PhD | Brown University | 401-863-7345 | Ellen_McCreedy@brown.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 17, 2021 | Oct 30, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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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.
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The principal investigator is blinded to random assignment of nursing homes to treatment or control conditions
| 4-months |
| 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. | 4-months |
| 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. | 4-months |
| 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. | 4-months |
| 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. | 4-months |
| 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. | 4-months |
| 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. | 4-months |
| 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+) | 4-months |
| 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. | 4-months |
| 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. | 4-months |
| 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 | 4-months |
| 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 | 4-months |
| 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 | 4-months |
| Elkhorn |
| Nebraska |
| 68022 |
| United States |
| CommuniCare Terrapins Division | Blue Ash | Ohio | 45241 | United States |
| Good Samaritan Society | Sioux Falls | South Dakota | 57108 | United States |
| 37277100 | Derived | Davoodi NM, Dionne L, Mor V, McCreedy EM. Personalization of Reminiscence Therapies in the Nursing Home Setting: Lessons from an Embedded Pragmatic Trial of a Music Intervention. J Am Med Dir Assoc. 2023 Sep;24(9):1277-1278.e2. doi: 10.1016/j.jamda.2023.04.027. Epub 2023 Jun 2. No abstract available. |
| 35038407 | Derived | McCreedy EM, Sisti A, Gutman R, Dionne L, Rudolph JL, Baier R, Thomas KS, Olson MB, Zediker EE, Uth R, Shield RR, Mor V. Pragmatic Trial of Personalized Music for Agitation and Antipsychotic Use in Nursing Home Residents With Dementia. J Am Med Dir Assoc. 2022 Jul;23(7):1171-1177. doi: 10.1016/j.jamda.2021.12.030. Epub 2022 Jan 14. |
| 35033176 | Derived | Olson MB, McCreedy EM, Baier RR, Shield RR, Zediker EE, Uth R, Thomas KS, Mor V, Gutman R, Rudolph JL. Measuring implementation fidelity in a cluster-randomized pragmatic trial: development and use of a quantitative multi-component approach. Trials. 2022 Jan 15;23(1):43. doi: 10.1186/s13063-022-06002-8. |
| 34620193 | Derived | McCreedy EM, Gutman R, Baier R, Rudolph JL, Thomas KS, Dvorchak F, Uth R, Ogarek J, Mor V. Measuring the effects of a personalized music intervention on agitated behaviors among nursing home residents with dementia: design features for cluster-randomized adaptive trial. Trials. 2021 Oct 7;22(1):681. doi: 10.1186/s13063-021-05620-y. |
| Not present in facility at followup |
|
| BG001 | Usual Care | Usual care for managing agitated and/or aggressive behaviors in the nursing home setting. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Cognitive function | Count of Participants | Participants |
|
| OG001 | Usual Care | Usual care for managing agitated and/or aggressive behaviors in the nursing home setting. |
|
|
|
| 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. | Posted | Number | 95% Confidence Interval | proportion of participants with behavior | 4-months |
|
|
|
|
| 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. | Posted | Mean | Standard Error | score on a scale | 4-months |
|
|
|
|
| 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. | Posted | Mean | Standard Error | adjusted percentage of participants | 4-months |
|
|
|
|
| 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. | Posted | Mean | Standard Error | adjusted percentage of participants | 4-months |
|
|
|
|
| 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. | Posted | Mean | Standard Error | adjusted percentage of participants | 4-months |
|
|
|
|
| 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. | Posted | Number | unadjusted percentage of participants | 4-months |
|
|
|
| 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. | Participants dropped from analysis if missing PHQ-9 score at baseline or followup | Posted | Mean | Standard Error | score on a scale | 4-months |
|
|
|
|
| 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+) | Posted | Number | 95% Confidence Interval | proportion of participants with behavior | 4-months |
|
|
|
|
| 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. | Posted | Number | 95% Confidence Interval | proportion of participants with behavior | 4-months |
|
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|
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| 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. | Posted | Number | 95% Confidence Interval | proportion of participants with emotion | 4-months |
|
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|
|
| 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 | Posted | Number | 95% Confidence Interval | proportion of participants with emotion | 4-months |
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| 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 | Posted | Number | 95% Confidence Interval | proportion of participants with emotion | 4-months |
|
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|
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| 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 | Posted | Number | 95% Confidence Interval | proportion of participants with emotion | 4-months |
|
|
|
|
| 37 |
| 532 |
| 0 |
| 532 |
| 0 |
| 532 |
| EG001 | Usual Care | Usual care for managing agitated and/or aggressive behaviors in the nursing home setting. | 31 | 541 | 0 | 541 | 0 | 541 |
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| D001523 | Mental Disorders |
| Many |
|
| Many |
|