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Clinical Trials/NCT04850807
NCT04850807
Completed
Not Applicable

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

Brown University4 sites in 1 country990 target enrollmentMay 14, 2021
ConditionsDementia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dementia
Sponsor
Brown University
Enrollment
990
Locations
4
Primary Endpoint
Frequency of Agitated and Aggressive Behaviors (Staff Report)
Status
Completed
Last Updated
last year

Overview

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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
May 14, 2021
End Date
September 8, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Vincent Mor

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

Brown University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Frequency of Agitated and Aggressive Behaviors (Staff Report)

Time Frame: 4-months

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.

Secondary Outcomes

  • 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)
  • Depression(4 months)

Study Sites (4)

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