Music & MEmory: A Pragmatic TRial for Nursing Home Residents With ALzheimer's Disease_part1

NCT ID: NCT03821844

Last Updated: 2025-02-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1073 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-03

Study Completion Date

2021-12-31

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, 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.

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. Some secondary outcomes will be tested with a stepped wedge design.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators
The principal investigator is blinded to random assignment of nursing homes to treatment or control conditions

Study Groups

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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.

Group Type EXPERIMENTAL

Music and 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.

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

Interventions

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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.

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 advanced dementia, defined by the presence of a dementia diagnosis and moderately or severely impaired daily decision-making

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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Westat

OTHER

Sponsor Role collaborator

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

References

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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.

Reference Type DERIVED
PMID: 40352475 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37277100 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35038407 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35033176 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34620193 (View on PubMed)

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_part1

Identifier Type: -

Identifier Source: org_study_id

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