Back to resultsRacial Variation in Response to Music Interventions for People With Alzheimer's Dementia
Primary Purpose
Alzheimer Disease
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Personalized Music Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of Alzheimer's disease
- English speaking
Exclusion Criteria:
- Deaf or hard of hearing
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Personalized Music Intervention
Arm Description
Participants will complete a series of questionnaires to identify participants' music preferences and participants' sensitivity to reward from musical engagement. The responses from the music preference questionnaires will be used to create a 1 hr playlist of songs by a member of the study team for the participant to be played daily for four weeks. After playlist is created and transmitted to MP3 device, participants will pick up the equipment and a compliance log will be given for the participant and participants' caregivers to confirm adherence to the protocol of daily listening. The platform will be Spotify, where the MP3 device given to participant at the start of the intervention will be preprogrammed with the participant's personal playlist on the platform. This trial is a supplementary treatment option for cognitive and neuropsychiatric assessments for AD, as such no alterations in the current treatment plans of any participant will be necessary.
Outcomes
Primary Outcome Measures
Change in severity of neuropsychiatric symptoms as assessed by the Neuropsychiatric Inventory-Questionnaire (NPI-Q) severity score
Examining changes in the NPI-Q which is an informant-based interview that assesses 12 neuropsychiatric symptoms of the participant. The NPI-Q includes 12 neuropsychiatric domains. Initial responses to each domain question are "Yes" (present) or "No" (absent). If the response to the domain question is "No", the informant goes to the next question. If "Yes", the informant then rates the severity of the symptoms present on a 3-point scale where 1 is "mild" and 3 is "severe".
Change in Montreal Cognitive Assessment (MoCA) score
Examining changes in the MoCA which is a cognitive test for Alzheimer's disease. The MoCA assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation to time and place. MoCA total scores range between 0 and 30; 18-25 = mild cognitive impairment, 10-17 = moderate cognitive impairment and less than 10 = severe cognitive impairment.
Secondary Outcome Measures
Correlation between the Barcelona Music Reward Questionnaire (BMRQ) score and NPI-Q score
The 20-item Barcelona Music Reward Questionnaire (administered at enrollment) assesses facets of the music and reward experiences with 5 factors: Musical Seeking, Emotion Evocation, Mood Regulation, Social Reward, and Sensory-Motor. Participants indicate the level of agreement with each statement by using a five-point scale ranging from ''fully disagree'' (1) to ''fully agree'' (5). BMRQ total scores range between 20 and 100. BMRQ total scores and NPI-Q totals scores will be used to assess whether these variables correlate. The correlation will be completed via statistical analysis in a chi squared test.
Correlation between the BMRQ score and MoCA score
The 20-item BMRQ (administered at enrollment) assesses facets of the music and reward experiences with 5 factors: Musical Seeking, Emotion Evocation, Mood Regulation, Social Reward, and Sensory-Motor. Participants indicate the level of agreement with each statement by using a five-point scale ranging from ''fully disagree'' (1) to ''fully agree'' (5). BMRQ total scores range between 20 and 100. BMRQ total scores and MoCA total scores will be used to assess whether these variables correlate. The correlation will be completed via statistical analysis in a chi squared test.
Full Information
NCT ID
NCT04282798
First Posted
February 21, 2020
Last Updated
June 16, 2020
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT04282798
Brief Title
Racial Variation in Response to Music Interventions for People With Alzheimer's Dementia
Official Title
Racial Variation in Response to Music Interventions for People With Alzheimer's Dementia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Withdrawn
Why Stopped
COVID delay and subsequent unavailability of staff.
Study Start Date
June 2020 (Anticipated)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
March 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This project will study the efficacy of a personalized receptive music intervention on neuropsychiatric symptoms and general cognitive function in patients with mild and moderate Alzheimer's disease (AD) by race.
Detailed Description
Music interventions have become a popular treatment option to be used alongside medicinal treatment for many chronic conditions including Alzheimer's disease. Healthcare providers and researchers have found that when patients who have chronic conditions engage with music that is patients' preference or most familiar to patients, the patients display positive changes in mood regulation and thinking overall. The investigators are trying to understand to what extent these music interventions could be useful for patients with Alzheimer's disease and for which populations the intervention is more effective for. To do this, the investigators are looking to recruit participants with a diagnosis of Alzheimer's disease to complete a four (4) week personalized music intervention where patients listen to a one-hour playlist created from patients' described preferences and songs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Personalized Music Intervention
Arm Type
Experimental
Arm Description
Participants will complete a series of questionnaires to identify participants' music preferences and participants' sensitivity to reward from musical engagement. The responses from the music preference questionnaires will be used to create a 1 hr playlist of songs by a member of the study team for the participant to be played daily for four weeks. After playlist is created and transmitted to MP3 device, participants will pick up the equipment and a compliance log will be given for the participant and participants' caregivers to confirm adherence to the protocol of daily listening. The platform will be Spotify, where the MP3 device given to participant at the start of the intervention will be preprogrammed with the participant's personal playlist on the platform. This trial is a supplementary treatment option for cognitive and neuropsychiatric assessments for AD, as such no alterations in the current treatment plans of any participant will be necessary.
Intervention Type
Other
Intervention Name(s)
Personalized Music Intervention
Intervention Description
Participants will complete a series of questionnaires to identify participants' music preferences and participants' sensitivity to reward from musical engagement. The responses from the music preference questionnaires will be used to create a 1 hr playlist of songs by a member of the study team for the participant to be played daily for four weeks. After playlist is created and transmitted to MP3 device, participants will pick up the equipment and a compliance log will be given for the participant and participants' caregivers to confirm adherence to the protocol of daily listening. The platform will be Spotify, where the MP3 device given to participant at the start of the intervention will be preprogrammed with the participant's personal playlist on the platform. This trial is a supplementary treatment option for cognitive and neuropsychiatric assessments for AD, as such no alterations in the current treatment plans of any participant will be necessary.
Primary Outcome Measure Information:
Title
Change in severity of neuropsychiatric symptoms as assessed by the Neuropsychiatric Inventory-Questionnaire (NPI-Q) severity score
Description
Examining changes in the NPI-Q which is an informant-based interview that assesses 12 neuropsychiatric symptoms of the participant. The NPI-Q includes 12 neuropsychiatric domains. Initial responses to each domain question are "Yes" (present) or "No" (absent). If the response to the domain question is "No", the informant goes to the next question. If "Yes", the informant then rates the severity of the symptoms present on a 3-point scale where 1 is "mild" and 3 is "severe".
Time Frame
Initial and final visit, four weeks apart
Title
Change in Montreal Cognitive Assessment (MoCA) score
Description
Examining changes in the MoCA which is a cognitive test for Alzheimer's disease. The MoCA assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation to time and place. MoCA total scores range between 0 and 30; 18-25 = mild cognitive impairment, 10-17 = moderate cognitive impairment and less than 10 = severe cognitive impairment.
Time Frame
Initial and final visit, four weeks apart
Secondary Outcome Measure Information:
Title
Correlation between the Barcelona Music Reward Questionnaire (BMRQ) score and NPI-Q score
Description
The 20-item Barcelona Music Reward Questionnaire (administered at enrollment) assesses facets of the music and reward experiences with 5 factors: Musical Seeking, Emotion Evocation, Mood Regulation, Social Reward, and Sensory-Motor. Participants indicate the level of agreement with each statement by using a five-point scale ranging from ''fully disagree'' (1) to ''fully agree'' (5). BMRQ total scores range between 20 and 100. BMRQ total scores and NPI-Q totals scores will be used to assess whether these variables correlate. The correlation will be completed via statistical analysis in a chi squared test.
Time Frame
At the end of the study, up to 9 months
Title
Correlation between the BMRQ score and MoCA score
Description
The 20-item BMRQ (administered at enrollment) assesses facets of the music and reward experiences with 5 factors: Musical Seeking, Emotion Evocation, Mood Regulation, Social Reward, and Sensory-Motor. Participants indicate the level of agreement with each statement by using a five-point scale ranging from ''fully disagree'' (1) to ''fully agree'' (5). BMRQ total scores range between 20 and 100. BMRQ total scores and MoCA total scores will be used to assess whether these variables correlate. The correlation will be completed via statistical analysis in a chi squared test.
Time Frame
At the end of the study, up to 9 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Alzheimer's disease
English speaking
Exclusion Criteria:
Deaf or hard of hearing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Rosenberg, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Melissa K Eustache, BS
Organizational Affiliation
Johns Hopkins University Kreiger School of Arts & Sciences
Official's Role
Study Director
12. IPD Sharing Statement
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Racial Variation in Response to Music Interventions for People With Alzheimer's Dementia
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