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Completed

NCT Number: NCT04850807

Music & MEmory: A Pragmatic TRial for Nursing Home Residents With ALzheimer's Disease (METRIcAL)_part2

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PruittHealth, Norcross, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

for Residents in Eligible Nursing Homes:

  • dislikes music
  • completely deaf

Treatment and study plan

Music & 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 at times when behaviors are likely

Primary outcomes

  1. Frequency of Agitated and Aggressive Behaviors (Staff Report)

    Time frame: 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 outcomes

  1. Frequency of Agitated and Aggressive Behaviors (Administrative Data)

    Time frame: 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.

  2. Antipsychotic Use

    Time frame: 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.

  3. Antianxietal Use

    Time frame: 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.

  4. Antidepressant Use

    Time frame: 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.

  5. Hypnotic Use

    Time frame: 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.

  6. Depression

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Brown University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Music & MEmory: A Pragmatic TRial for Nursing Home Residents With ALzheimer's Disease

Acronym: METRIcAL

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 20, 2021
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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