Music & MEmory: A Pragmatic TRial for Nursing Home Residents With ALzheimer's Disease (METRIcAL)_part2
- Conditions
- Dementia
- Interventions
- Behavioral: Music & Memory
- Registration Number
- NCT04850807
- Lead Sponsor
- Brown University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 990
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Music & Memory 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
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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). 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.
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.
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.
Trial Locations
- Locations (4)
CommuniCare Terrapins Division
🇺🇸Blue Ash, Ohio, United States
Good Samaritan Society
🇺🇸Sioux Falls, South Dakota, United States
PruittHealth
🇺🇸Norcross, Georgia, United States
Vetter Senior Living
🇺🇸Elkhorn, Nebraska, United States