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

NCT ID: NCT04850807

Last Updated: 2025-02-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

990 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-14

Study Completion Date

2022-09-08

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The investigator's primary outcome (staff report of resident agitated and aggressive behaviors) will be evaluated using a parallel design
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators
Principal investigator is blinded to allocation of nursing homes to treatment or control conditions

Study Groups

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Usual Care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

Music & Memory

Intervention Type 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

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Owned by partnering health care corporations
* Medicare / Medicaid-certified
* Have at least 20 eligible residents


* Reside in eligible nursing home for last 90 days
* Have a dementia diagnosis

Exclusion Criteria

* 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


* dislikes music
* completely deaf
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Brown University

OTHER

Sponsor Role lead

Responsible Party

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Vincent Mor

Florence Pirce Grant University Professor, Professor of Health Services, Policy and Practice

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vincent Mor, PHD

Role: PRINCIPAL_INVESTIGATOR

Brown University, School of Public Health

Locations

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PruittHealth

Norcross, Georgia, United States

Site Status

Vetter Senior Living

Elkhorn, Nebraska, United States

Site Status

CommuniCare Terrapins Division

Blue Ash, Ohio, United States

Site Status

Good Samaritan Society

Sioux Falls, South Dakota, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R33AG057451

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R33AG057451_part2

Identifier Type: -

Identifier Source: org_study_id

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