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

Sponsor
Brown University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04850807
Collaborator
National Institute on Aging (NIA) (NIH)
810
Enrollment
4
Locations
2
Arms
16
Anticipated Duration (Months)
202.5
Patients Per Site
12.6
Patients Per Site Per Month

Study Details

Study Description

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
  • Behavioral: Music & Memory
 N/A

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

Study Type:
Interventional
Anticipated 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 designThe 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
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

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

Primary Outcome Measures

  1. Frequency of agitated and aggressive behaviors (staff report) [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) [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 [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 [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 [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 [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 [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

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 PruittHealth Norcross Georgia United States 30093
2 Vetter Senior Living Elkhorn Nebraska United States 68022
3 CommuniCare Terrapins Division Blue Ash Ohio United States 45241
4 Good Samaritan Society Sioux Falls South Dakota United States 57108

Sponsors and Collaborators

  • Brown University
  • National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Vincent Mor, PHD, Brown University, School of Public Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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
First Posted:
Apr 20, 2021
Last Update Posted:
Mar 25, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Alzheimer Disease

Study Results

No Results Posted as of Mar 25, 2022