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

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ClinicalTrials.gov Identifier: NCT04850807
Recruitment Status : Enrolling by invitation
First Posted : April 20, 2021
Last Update Posted : January 21, 2022
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Vincent Mor, Brown University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dementia Behavioral: Music & Memory Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 810 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The investigator's primary outcome (staff report of resident agitated and aggressive behaviors) will be evaluated using a parallel design
Masking: Single (Investigator)
Masking Description: Principal investigator is blinded to allocation of nursing homes to treatment or control conditions
Primary Purpose: Supportive Care
Official Title: Music & MEmory: A Pragmatic TRial for Nursing Home Residents With ALzheimer's Disease
Actual Study Start Date : May 1, 2021
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Usual Care
Usual care for managing agitated and/or aggressive behaviors in the nursing home setting
Experimental: Music & 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 at early signs of agitation
 Behavioral: Music & 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 at times when behaviors are likely


Outcome Measures
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Primary Outcome Measures :
  1. Frequency of agitated and aggressive behaviors (staff report) [ Time Frame: 8-months ]
    The tool used to interview staff about resident behaviors is the Cohen-Mansfield Agitation Inventory (CMAI). Research staff interview nursing staff who knows 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 three points in time: baseline, 4 months, and 8 months. The minimum of the 4- and 8-month scores will be the study outcome for intervention and control participants. The minimum observed frequency of agitated and aggressive behaviors after intended exposure to the intervention (treatment) or after 8-months (control), conditional upon survival to at least one post-intervention observation (up to 4 months after baseline measurement).


Secondary Outcome Measures :
  1. Frequency of agitated and aggressive behaviors (administrative data) [ Time Frame: 8 months ]
    The Aggressive Behavior Scale is a 4 item measure describing the frequency of physical behavioral symptoms directed toward others; verbal behavioral symptoms directed toward others; other behavioral symptoms not directed toward others; and behaviors related to resisting necessary care. For each item, frequency in the past week is reported as: behavior not exhibited (0); behavior occurred 1-3 days (1); behavior occurred 4-6 days (2); or behavior occurred daily (3). The Aggressive Behavior Scale ranges from 0 to 12, with higher scores indicating more frequent agitated and/or aggressive behaviors. Mean total scores will be compared for treatment and control populations.

  2. Antipsychotic use [ Time Frame: 8 months ]
    Any antipsychotic use in the past week and days of use in the past week, based on Minimum Data Set (standardized assessment of nursing home residents). Comparison of percent with any use and mean days will be compared for treatment and control populations

  3. Antianxietal use [ Time Frame: 8 months ]
    Any antianxietal use in the past week and days of use in the past week, based on Minimum Data Set (standardized assessment of nursing home residents). Comparison of percent with any use and mean days will be compared for treatment and control populations

  4. Antidepressant use [ Time Frame: 8 months ]
    Any antidepressant use in the past week and days of use in the past week, based on Minimum Data Set (standardized assessment of nursing home residents). Comparison of percent with any use and mean days will be compared for treatment and control populations

  5. Hypnotic use [ Time Frame: 8 months ]
    Any hypnotic use in the past week and days of use in the past week, based on Minimum Data Set (standardized assessment of nursing home residents). Comparison of percent with any use and mean days for treatment and control populations, before and after implementation

  6. Depression [ Time Frame: 8 months ]
    The Patient Health Questionnaire is a 9-item screening assessment for depression severity. For each item, respondents indicate the frequency of the symptom in the past 2 weeks using the following choices: never or one day (0); 2-6 days (1); 7-11 days (2); or 12-14 days (3). Total scores range from 0 to 27, with higher scores indicating more frequent depressive symptoms. Average total scores will be compared for treatment and control populations.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for Nursing Homes:

  • Owned by partnering health care corporations
  • Medicare / Medicaid-certified
  • Have at least 20 eligible residents

Inclusion Criteria for Residents in Eligible Nursing Homes

  • Reside in eligible nursing home for last 90 days
  • Have a dementia diagnosis

Exclusion Criteria for Nursing Homes:

  • 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

Exclusion Criteria for Residents in Eligible Nursing Homes:

  • dislikes music
  • completely deaf
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04850807


Locations
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United States, Georgia
PruittHealth
Norcross, Georgia, United States, 30093
United States, Nebraska
Vetter Senior Living
Elkhorn, Nebraska, United States, 68022
United States, Ohio
CommuniCare Terrapins Division
Blue Ash, Ohio, United States, 45241
United States, South Dakota
Good Samaritan Society
Sioux Falls, South Dakota, United States, 57108
Sponsors and Collaborators
Brown University
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Vincent Mor, PHD Brown University, School of Public Health
More Information
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Responsible Party: Vincent Mor, Florence Pirce Grant University Professor, Professor of Health Services, Policy and Practice, Brown University
ClinicalTrials.gov Identifier: NCT04850807    
Other Study ID Numbers: R33AG057451_part2
R33AG057451 ( U.S. NIH Grant/Contract )
First Posted: April 20, 2021    Key Record Dates
Last Update Posted: January 21, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders