NCT03821844

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,073

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2019

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 30, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

June 3, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

July 27, 2023

Completed
Last Updated

February 28, 2025

Status Verified

February 1, 2025

Enrollment Period

2.2 years

First QC Date

October 18, 2018

Results QC Date

October 31, 2022

Last Update Submit

February 7, 2025

Conditions

Dementia

Outcome Measures

Primary Outcomes (1)

  • Frequency of Agitated and Aggressive Behaviors (Staff Report)

    The tool used to interview staff about resident behaviors is the Cohen-Mansfield Agitation Inventory. Research staff interview a nursing staff member who knows the resident well to ask how frequently 29 agitated and/or 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 Cohen-Mansfield Agitation Inventory range from 29 to 203, with higher scores representing more frequent agitated and/or aggressive behaviors. Adjusted mean overall scores will be compared for treatment and control populations.

    4-months

Secondary Outcomes (13)

  • Frequency of Verbal Agitated and Aggressive Behaviors (Direct Observation)

    4-months

  • Frequency of Agitated and Aggressive Behaviors (Administrative Data)

    4-months

  • Antipsychotic Use

    4-months

  • Antianxietal Use

    4-months

  • Antidepressant Use

    4-months

  • +8 more secondary outcomes

Study Arms (2)

Music and Memory

EXPERIMENTAL

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.

Behavioral: Music and Memory

Usual Care

NO INTERVENTION

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

Interventions

Music and MemoryBEHAVIORAL

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.

Music and Memory

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

PruittHealth

Norcross, Georgia, 30093, United States

Location

Vetter Senior Living

Elkhorn, Nebraska, 68022, United States

Location

CommuniCare Terrapins Division

Blue Ash, Ohio, 45241, United States

Location

Good Samaritan Society

Sioux Falls, South Dakota, 57108, United States

Location

Related Publications (5)

  • 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.

    PMID: 40352475DERIVED

  • 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.

    PMID: 37277100DERIVED

  • 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.

    PMID: 35038407DERIVED

  • 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.

    PMID: 35033176DERIVED

  • 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.

    PMID: 34620193DERIVED

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Ellen McCreedy, PhD
Organization
Brown University
Ellen_McCreedy@brown.edu
401-863-7345

Study Officials

  • Vincent Mor, PhD

    Brown University, School of Public Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The principal investigator is blinded to random assignment of nursing homes to treatment or control conditions
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Florence Pirce Grant University Professor, Professor of Health Services, Policy and Practice

Study Record Dates

First Submitted

October 18, 2018

First Posted

January 30, 2019

Study Start

June 3, 2019

Primary Completion

August 1, 2021

Study Completion

December 31, 2021

Last Updated

February 28, 2025

Results First Posted

July 27, 2023

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

US(4)