Clinical trial NCT03821844: Music & MEmory: A Pragmatic TRial for Nursing Home Residents With ALzheimer's Disease_part1
Official title: Music & MEmory: A Pragmatic TRial for Nursing Home Residents With ALzheimer's Disease_part1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: Westat
name: National Institute on Aging (NIA)
First posted: 2019-01-30
Enrollment: 1073
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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 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.

Eligibility 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 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

Primary outcomes:
measure: Frequency of Agitated and Aggressive Behaviors (Staff Report)
timeFrame: 4-months
Secondary outcomes:
measure: Frequency of Verbal Agitated and Aggressive Behaviors (Direct Observation)
timeFrame: 4-months
measure: Frequency of Agitated and Aggressive Behaviors (Administrative Data)
timeFrame: 4-months
measure: Antipsychotic Use
timeFrame: 4-months
measure: Antianxietal Use
timeFrame: 4-months
measure: Antidepressant Use
timeFrame: 4-months
measure: Hypnotic Use
timeFrame: 4-months
measure: Depression
timeFrame: 4-months
measure: Frequency of Physical Agitated and Aggressive Behaviors (Direct Observation)
timeFrame: 4-months
measure: Observed Pleasure
timeFrame: 4-months
measure: Observed Anger
timeFrame: 4-months
measure: Observed Sadness
timeFrame: 4-months
measure: Observed Alertness
timeFrame: 4-months
measure: Observed Anxiety
timeFrame: 4-months
Other outcomes:
Locations:
city: Norcross
country: United States
facility: PruittHealth
state: Georgia
city: Elkhorn
country: United States
facility: Vetter Senior Living
state: Nebraska
city: Blue Ash
country: United States
facility: CommuniCare Terrapins Division
state: Ohio
city: Sioux Falls
country: United States
facility: Good Samaritan Society
state: South Dakota
Study officials:
affiliation: Brown University, School of Public Health
name: Vincent Mor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McCreedy EM, Sisti A, Gutman R, Dionne L, Rudolph JL, Baier R, Thomas KS, Olson MB, Zediker EE, Uth R, Shield RR, Mor V. Pragmatic Trial of Personalized Music for Agitation and Antipsychotic Use in Nursing Home Residents With Dementia. J Am Med Dir Assoc. 2022 Jul;23(7):1171-1177. doi: 10.1016/j.jamda.2021.12.030. Epub 2022 Jan 14.
citation: Olson MB, McCreedy EM, Baier RR, Shield RR, Zediker EE, Uth R, Thomas KS, Mor V, Gutman R, Rudolph JL. Measuring implementation fidelity in a cluster-randomized pragmatic trial: development and use of a quantitative multi-component approach. Trials. 2022 Jan 15;23(1):43. doi: 10.1186/s13063-022-06002-8.
citation: McCreedy EM, Gutman R, Baier R, Rudolph JL, Thomas KS, Dvorchak F, Uth R, Ogarek J, Mor V. Measuring the effects of a personalized music intervention on agitated behaviors among nursing home residents with dementia: design features for cluster-randomized adaptive trial. Trials. 2021 Oct 7;22(1):681. doi: 10.1186/s13063-021-05620-y.