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

NCT04850807 | Completed Results DMC

• 2 other identifiers: R33AG057451_part2R33AG057451
• Study Type: interventional
• Target: 990
• Locations: 1 country
• Sites: 4

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.

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 (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.

  4-months

Secondary Outcomes (6)

• Frequency of Agitated and Aggressive Behaviors (Administrative Data)

  4 months

• Antipsychotic Use

  4 months

• Antianxietal Use

  4 months

• Antidepressant Use

  4 months

• Hypnotic Use

  4 months

Study Arms (2)

Usual Care

NO INTERVENTION

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

Music & 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 at early signs of agitation

Behavioral: Music & Memory

Interventions

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

Music & Memory

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (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 a dementia diagnosis

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

Sponsors & Collaborators

• Brown University: lead
• National Institute on Aging (NIA): collaborator

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

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental 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: Principal investigator is blinded to allocation of nursing homes to treatment or control conditions
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Florence Pirce Grant University Professor, Professor of Health Services, Policy and Practice

Model Details: The investigator's primary outcome (staff report of resident agitated and aggressive behaviors) will be evaluated using a parallel design

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 20, 2021
• Study Start: May 14, 2021
• Primary Completion: September 8, 2022
• Study Completion: September 8, 2022
• Last Updated: February 28, 2025
• Results First Posted: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)