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Clinical Trials/NCT03821844
NCT03821844
Completed
Not Applicable

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

Brown University4 sites in 1 country1,073 target enrollmentJune 3, 2019
ConditionsDementia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dementia
Sponsor
Brown University
Enrollment
1073
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, 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.

Registry
clinicaltrials.gov
Start Date
June 3, 2019
End Date
December 31, 2021
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. 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.

Secondary Outcomes

  • 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)
  • Hypnotic Use(4-months)
  • Depression(4-months)
  • Frequency of Physical Agitated and Aggressive Behaviors (Direct Observation)(4-months)
  • Observed Pleasure(4-months)
  • Observed Anger(4-months)
  • Observed Sadness(4-months)
  • Observed Alertness(4-months)
  • Observed Anxiety(4-months)

Study Sites (4)

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