DementiaMETRIcALNCT03821844
Music & MEmory: A Pragmatic TRial for Nursing Home Residents With ALzheimer's Disease_part1
A study testing Music and Memory in people with Dementia, run by Brown University at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia
- What is being tested?
- Music and Memory
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,073 participants
- Where
- 4 sitesUnited States
- Study dates
- 3 Jun 2019to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Owned by partnering health care corporations
- Medicare / Medicaid-certified
- Have at least 20 eligible residents
- 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
Who cannot join
- 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
- dislikes music
- completely deaf
Trial locations and contacts
4 sites in 1 country.
United States4 sites
CommuniCare Terrapins Division
Blue Ash, Ohio, 45241
Vetter Senior Living
Elkhorn, Nebraska, 68022
PruittHealth
Norcross, Georgia, 30093
Good Samaritan Society
Sioux Falls, South Dakota, 57108
About this study
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.
Read the 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.
- Conditions
- Dementia
- Being tested
- Music and Memory
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music and MemoryBehavioural
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 group | Role | What they receive |
|---|---|---|
| Music and Memory | Experimental | 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. Receives: Behavioral: Music and Memory |
| Usual Care | No intervention | Usual care for managing agitated and/or aggressive behaviors in the nursing home setting. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Agitated and Aggressive Behaviors (Staff Report)
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. Adjusted mean overall scores will be compared for treatment and control populations.
Measured: 4-months
Secondary outcomes (13)
Frequency of Verbal Agitated and Aggressive Behaviors (Direct Observation)
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). Ordinal outcomes quantify the number of physical and verbal agitated behaviors that occurred during the ABMI observations. The levels of these outcomes are None (0), Some (1 - 3) and Many (4 or more) observed behaviors.
Measured: 4-months
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.
Measured: 4-months
Antipsychotic Use
Any antipsychotic use in the past week, based on Minimum Data Set (standardized assessment of nursing home residents). Measure type of mean is chosen based on adjusted percentage with standard errors from a multilevel, difference in difference regression models.
Measured: 4-months
Antianxietal Use
Any antianxietal use in the past week, based on Minimum Data Set (standardized assessment of nursing home residents). Measure type of mean is chosen based on adjusted percentage with standard errors from a multilevel, difference in difference regression models.
Measured: 4-months
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). Measure type of mean is chosen based on adjusted percentage with standard errors from a multilevel, difference in difference regression models.
Measured: 4-months
Hypnotic Use
Any hypnotic use in the past week, based on Minimum Data Set (standardized assessment of nursing home residents). Comparison of percent with any use will be compared for treatment and control populations.
Measured: 4-months
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.
Measured: 4-months
Frequency of Physical Agitated and Aggressive Behaviors (Direct Observation)
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). We report the proportion of participants with no behaviors, some behaviors (1-3 ), many behaviors (4+)
Measured: 4-months
Observed Pleasure
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. We report the proportion of participants with any observed emotion during the structured observations after four months of follow-up.
Measured: 4-months
Observed Anger
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. We report the proportion of participants with any observed anger during observations after four months of followup.
Measured: 4-months
Observed Sadness
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. We report the proportion of participants any sadness observed during structured observations after four months of follow-up
Measured: 4-months
Observed Alertness
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. We report the proportion of participants with any observed alertness during structured observations after four months of followup
Measured: 4-months
Observed Anxiety
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. We report the proportion of participants with any observed anxiety during structured observations after four months of follow-up
Measured: 4-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start3 Jun 2019
- Primary completion1 Aug 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,073 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- Westat, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Vincent Mor, Brown University
- Investigators
- Vincent Mor, PhD, Principal investigator, Brown University, School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03821844
- Sponsor's protocol ID
- R33AG057451_part1
- Other IDs
- R33AG057451
- Acronym
- METRIcAL
- Status last verified
- Feb 2025
- First submitted
- 18 Oct 2018
- Last updated
- 28 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Conard RA, Baier RR, Sisti A, Dionne L, McCreedy EM. Resident and Nursing Home Factors Associated With Adherence to a Personalized Music Intervention: Secondary Analyses From Music & MEmory: A Pragmatic TRial for Nursing Home Residents With ALzheimer's Disease (METRIcAL). J Aging Res. 2025 May 2;2025:2679462. doi: 10.1155/jare/2679462. eCollection 2025.
PubMed 40352475Weems JA, Wittenberg GF, Baier RR, Reddy A, McCreedy E. Moderators of Adherence Within a Nursing Home Pragmatic Trial of Personalized Music. Gerontologist. 2025 May 10;65(6):gnaf128. doi: 10.1093/geront/gnaf128.
PubMed 40243529Davoodi NM, Dionne L, Mor V, McCreedy EM. Personalization of Reminiscence Therapies in the Nursing Home Setting: Lessons from an Embedded Pragmatic Trial of a Music Intervention. J Am Med Dir Assoc. 2023 Sep;24(9):1277-1278.e2. doi: 10.1016/j.jamda.2023.04.027. Epub 2023 Jun 2. No abstract available.
PubMed 37277100McCreedy 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.
PubMed 35038407Olson 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.
PubMed 35033176McCreedy 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.
PubMed 34620193
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music & MEmory: A Pragmatic TRial for Nursing Home Residents With ALzheimer's Disease_part1
- ClinicalTrials.gov ID
- NCT03821844
- Acronym / sponsor ID
- METRIcAL / R33AG057451_part1
- Conditions
- Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,073 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- Westat, National Institute on Aging (NIA)
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 30 Jan 2019 (actual)
- Results
- Posted 27 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Music and Memory | Experimental | Behavioral: Music and MemoryMusic 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. |
| Usual Care | No intervention | –Usual care for managing agitated and/or aggressive behaviors in the nursing home setting. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Owned by partnering health care corporations
- Medicare / Medicaid-certified
- Have at least 20 eligible residents
- 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
Key exclusion criteria (4 listed)
- 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
- dislikes music
- completely deaf
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music and MemoryMusic 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. | Behavioural | Music and Memory |
Primary outcome
Frequency of Agitated and Aggressive Behaviors (Staff Report)
Time frame: 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. Adjusted mean overall scores will be compared for treatment and control populations.
13 secondary outcomes
Frequency of Verbal Agitated and Aggressive Behaviors (Direct Observation)
Time frame: 4-months
Frequency of Agitated and Aggressive Behaviors (Administrative Data)
Time frame: 4-months
Antipsychotic Use
Time frame: 4-months
Antianxietal Use
Time frame: 4-months
Antidepressant Use
Time frame: 4-months
Hypnotic Use
Time frame: 4-months
Depression
Time frame: 4-months
Frequency of Physical Agitated and Aggressive Behaviors (Direct Observation)
Time frame: 4-months
Observed Pleasure
Time frame: 4-months
Observed Anger
Time frame: 4-months
Observed Sadness
Time frame: 4-months
Observed Alertness
Time frame: 4-months
Observed Anxiety
Time frame: 4-months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40352475Conard RA, Baier RR, Sisti A, Dionne L, McCreedy EM. Resident and Nursing Home Factors Associated With Adherence to a Personalized Music Intervention: Secondary Analyses From Music & MEmory: A Pragmatic TRial for Nursing Home Residents With ALzheimer's Disease (METRIcAL). J Aging Res. 2025 May 2;2025:2679462. doi: 10.1155/jare/2679462. eCollection 2025.
- Derived from this study: PubMed 40243529Weems JA, Wittenberg GF, Baier RR, Reddy A, McCreedy E. Moderators of Adherence Within a Nursing Home Pragmatic Trial of Personalized Music. Gerontologist. 2025 May 10;65(6):gnaf128. doi: 10.1093/geront/gnaf128.
- Derived from this study: PubMed 37277100Davoodi NM, Dionne L, Mor V, McCreedy EM. Personalization of Reminiscence Therapies in the Nursing Home Setting: Lessons from an Embedded Pragmatic Trial of a Music Intervention. J Am Med Dir Assoc. 2023 Sep;24(9):1277-1278.e2. doi: 10.1016/j.jamda.2023.04.027. Epub 2023 Jun 2. No abstract available.
- Derived from this study: PubMed 35038407McCreedy 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.
- Derived from this study: PubMed 35033176Olson 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.
- Derived from this study: PubMed 34620193McCreedy 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent Mor, PhD principal investigator
Brown University, School of Public Health
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music and Memory in people with Dementia, run by Brown University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Agitated and Aggressive Behaviors (Staff Report) (time frame: 4-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03821844, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.