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

Dementia Clinical Trial

— METRIcAL  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04850807
• Other study ID #: R33AG057451_part2
• Secondary ID: R33AG057451
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: April 2023
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 810
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia

Intervention

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

Locations

Country	Name	City	State
United States	CommuniCare Terrapins Division	Blue Ash	Ohio
United States	Vetter Senior Living	Elkhorn	Nebraska
United States	PruittHealth	Norcross	Georgia
United States	Good Samaritan Society	Sioux Falls	South Dakota

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of agitated and aggressive behaviors (staff report)	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).	8-months
Secondary	Frequency of agitated and aggressive behaviors (administrative data)	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.	8 months
Secondary	Antipsychotic use	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	8 months
Secondary	Antianxietal use	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	8 months
Secondary	Antidepressant use	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	8 months
Secondary	Hypnotic use	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	8 months
Secondary	Depression	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.	8 months