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

Brown University

Status: Completed

Conditions: Dementia

Treatments: Behavioral: Music & Memory

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04850807

R33AG057451_part2

R33AG057451 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 990 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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990 participants in 2 patient groups

Usual Care

No Intervention group

Description:

Usual care for managing agitated and/or aggressive behaviors in the nursing home setting

Music & Memory

Experimental group

Description:

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

Treatment:

Behavioral: Music & Memory