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

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ClinicalTrials.gov Identifier: NCT03821844
Recruitment Status : Not yet recruiting
First Posted : January 30, 2019
Last Update Posted : March 19, 2019
Sponsor:
Collaborators:
Westat
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Vincent Mor, Brown University

Tracking Information
First Submitted Date  ICMJE October 18, 2018
First Posted Date  ICMJE January 30, 2019
Last Update Posted Date March 19, 2019
Estimated Study Start Date  ICMJE May 1, 2019
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2019)
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. 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03821844 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2019)
  • Frequency of agitated and aggressive behaviors (direct observation) [ Time Frame: 8-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.
  • 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 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.
  • 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 for treatment and control populations before and after implementation
  • 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 for treatment and control populations before and after implementation
  • 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 for treatment and control populations before and after implementation
  • 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
  • Observed emotion [ Time Frame: 8-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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Music & MEmory: A Pragmatic TRial for Nursing Home Residents With ALzheimer's Disease
Official Title  ICMJE Music & MEmory: A Pragmatic TRial for Nursing Home Residents With ALzheimer's Disease
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 pragmatic cluster randomized control trial of personalized music (Music and Memory) for nursing home residents with moderate to severe dementia living in 81 nursing homes 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. Nursing home staff provide residents with dementia with music playlists tailored to their personal history of music preferences. The program assumes that musical memories remain present and that personalized music can quell the anxiety and agitation stimulated by the confusion secondary to dementia.

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Dementia
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Music and Memory
  • No Intervention: Usual Care
    Usual care for managing agitated and/or aggressive behaviors in the nursing home setting.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 28, 2019)
1620
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ellen McCreedy 4018637345 ellen_mccreedy@brown.edu
Contact: Cindy Williams 4018639627 cindy_williams@brown.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03821844
Other Study ID Numbers  ICMJE R33AG057451( U.S. NIH Grant/Contract )
R33AG057451 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Vincent Mor, Brown University
Study Sponsor  ICMJE Brown University
Collaborators  ICMJE
  • Westat
  • National Institute on Aging (NIA)
Investigators  ICMJE
Principal Investigator: Vincent Mor, PhD Brown University, School of Public Health
PRS Account Brown University
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP