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

Sponsor
Brown University (Other)
Overall Status
Completed
CT.gov ID
NCT03821844
Collaborator
Westat (Other), National Institute on Aging (NIA) (NIH)
976
Enrollment
4
Locations
2
Arms
32
Actual Duration (Months)
244
Patients Per Site
7.6
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 and 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, 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
976 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. Some secondary outcomes will be tested with a stepped wedge design.The investigator's primary outcome (staff report of resident agitated and aggressive behaviors) will be evaluated using a parallel design. Some secondary outcomes will be tested with a stepped wedge design.
Masking:
Single (Investigator)
Masking Description:
The principal investigator is blinded to random assignment 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_part1
Actual Study Start Date :
May 1, 2019
Actual Primary Completion Date :
Aug 1, 2021
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Music and 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.

Behavioral: Music and 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.
No Intervention: Usual Care

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

Outcome Measures

Primary Outcome Measures

  1. Frequency of agitated and aggressive behaviors (staff report) [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. Mean overall scores will be compared for treatment and control populations.

Secondary Outcome Measures

  1. Frequency of agitated and aggressive behaviors (direct observation) [4-months]

    The tool used to directly observe resident behaviors is the Agitation Behavior Mapping Instrument. Research staff observe residents for short intervals (3 minutes per observation) and record the number of times 14 specific verbally and physically agitated behaviors occurred (up to 10 times per observation). Total scores on the Agitation Behavior Mapping Instrument range from 0 to 140, with higher scores representing more agitated and/or aggressive behaviors. Mean total scores will be compared for treatment and control populations.

  2. Frequency of agitated and aggressive behaviors (administrative data) [4-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 report 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.

  3. Antipsychotic use [4-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

  4. Antianxietal use [4-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

  5. Antidepressant use [4-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

  6. Hypnotic use [4-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 will be compared for treatment and control populations

  7. Observed emotion [4-months]

    The Observed Emotion Rating Scale is completed by a trained observer to document duration of five observed emotional states (pleasure, anger, anxiety / fear, sadness, and general alertness) during short observations (3 minutes per observation). For each emotional state, the researcher indicates whether or not the emotion was observed: never (1); less than 16 seconds (2); 16-59 seconds (3); 1-2 minutes (4); or 3+ minutes (5). Total scores range from 5 to 25, with higher scores indicating greater duration of observed emotion. Average observed emotion scores will be compared for treatment and control populations.

  8. Depression [4-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 advanced dementia, defined by the presence of a dementia diagnosis and moderately or severely impaired daily decision-making

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
  • Westat
  • 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:
NCT03821844
Other Study ID Numbers:
  • R33AG057451_part1
  • R33AG057451
First Posted:
Jan 30, 2019
Last Update Posted:
Mar 4, 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 4, 2022