N/A
N=1,073
Music & MEmory: A Pragmatic TRial for Nursing Home Residents With ALzheimer's Disease_part1
Dementia
Bottom Line
View on ClinicalTrials.gov: NCT03821844 ↗Enrolled (actual)
1,073
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcome: Primary: Frequency of Agitated and Aggressive Behaviors (Staff Report) — 50.31; 48.04 score on scale — p=< 0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Music and Memory (Behavioral)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Brown University
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of Agitated and Aggressive Behaviors (Staff Report) |
50.31; 48.04 | < 0.05 sig |
| SECONDARY Frequency of Verbal Agitated and Aggressive Behaviors (Direct Observation) |
0.80; 0.80; 0.13; 0.13; 0.08; 0.07 | < 0.05 sig |
| SECONDARY Frequency of Agitated and Aggressive Behaviors (Administrative Data) |
0.42; 0.40 | < 0.05 sig |
| SECONDARY Antipsychotic Use |
26.2; 29.6 | < 0.05 sig |
| SECONDARY Antianxietal Use |
20.8; 24.3 | < 0.05 sig |
| SECONDARY Antidepressant Use |
57.5; 58.8 | < 0.05 sig |
| SECONDARY Hypnotic Use |
0.83; 1.22 | — |
| SECONDARY Depression |
2.09; 2.30 | < 0.05 sig |
| SECONDARY Frequency of Physical Agitated and Aggressive Behaviors (Direct Observation) |
0.85; 0.90; 0.12; 0.09; 0.03; 0.01 | < 0.05 sig |
| SECONDARY Observed Pleasure |
0.36; 0.29 | < 0.05 sig |
| SECONDARY Observed Anger |
0.04; 0.03 | < 0.05 sig |
| SECONDARY Observed Sadness |
0.07; 0.06 | < 0.05 sig |
| SECONDARY Observed Alertness |
0.78; 0.76 | < 0.05 sig |
| SECONDARY Observed Anxiety |
0.12; 0.13 | < 0.05 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT03821844). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.