Personalized Music Therapy and Agitation in Dementia
Primary Purpose
Alzheimer's Disease, Vascular Dementia
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Personalized music
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease focused on measuring moderate dementia, severe dementia, Alzheimer's disease, Vascular dementia, agitation, personalized music therapy
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of dementia with possible or probable cause of Alzheimer's disease, Vascular disease, mixed dementia;
- moderate stage of dementia, a score of <20 on MMSE;
- Age 60 to 90 inclusive;
- Preserved hearing (hearing aids are permissible);
- Pittsburgh agitation scale score of ≥ 3 on at least on 3 occasions over a period of 5 days.
Exclusion Criteria:
- auditory deficits requiring correction beyond hearing aids.
- no substitute decision maker available to indicate music preference and patient unable to answer for themselves.
- recent acute event eg. MI, fractures, or major infection (not UTI)
- patients receiving standing orders of medication for personal care
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Personalized music
Arm Description
Outcomes
Primary Outcome Measures
Changes in agitation
Changes in agitation as measured by the Pittsburgh agitation questionnaire and "as needed" psychotropic medications for agitation required during hygiene care will be quantitatively assessed. Statistical analyses will be performed to compare levels of agitation and use of "as needed" psychotropic medications for agitation with personalized music therapy with headphones and non-personalized music intervention or usual care.
Secondary Outcome Measures
Full Information
NCT ID
NCT02147652
First Posted
May 21, 2014
Last Updated
September 24, 2019
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT02147652
Brief Title
Personalized Music Therapy and Agitation in Dementia
Official Title
Assessing the Effects of a Personalized Music Therapy With Headphones on Agitation in Patients With Dementia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 14, 2014 (Actual)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
June 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Symptoms of agitation include abuse or aggressive behaviour toward self or others, appropriate behaviour performed with inappropriate frequency, or behaviours that are inappropriate according to social standards. In the later stages of dementia agitation can contribute significantly to patient distress and caregiver stress, and has been associated with poor quality of life. Previous research studies have shown some evidence that personalized music played in daily care situations reduces agitation. The purpose of this study is to evaluate the effects of personalized music therapy via headphones on agitation during hygiene care (grooming).
This study will involve 60 in-patients of the Geriatric Psychiatry ward of Toronto Rehabilitation Institute. The study would take place over the span of 2 weeks and would involve listening to personalized and either non-personalized or no music during daily hygiene care (grooming). Enrolment is completely voluntary and all personal data obtained will remain confidential.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Vascular Dementia
Keywords
moderate dementia, severe dementia, Alzheimer's disease, Vascular dementia, agitation, personalized music therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Personalized music
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Personalized music
Primary Outcome Measure Information:
Title
Changes in agitation
Description
Changes in agitation as measured by the Pittsburgh agitation questionnaire and "as needed" psychotropic medications for agitation required during hygiene care will be quantitatively assessed. Statistical analyses will be performed to compare levels of agitation and use of "as needed" psychotropic medications for agitation with personalized music therapy with headphones and non-personalized music intervention or usual care.
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of dementia with possible or probable cause of Alzheimer's disease, Vascular disease, mixed dementia;
moderate stage of dementia, a score of <20 on MMSE;
Age 60 to 90 inclusive;
Preserved hearing (hearing aids are permissible);
Pittsburgh agitation scale score of ≥ 3 on at least on 3 occasions over a period of 5 days.
Exclusion Criteria:
auditory deficits requiring correction beyond hearing aids.
no substitute decision maker available to indicate music preference and patient unable to answer for themselves.
recent acute event eg. MI, fractures, or major infection (not UTI)
patients receiving standing orders of medication for personal care
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmela Tartaglia, MD, FRCPC
Organizational Affiliation
Assistant Professor, University of Toronto; Toronto Western Hospital, University Health Network; Tanz Centre for Research in Neurodegenerative Disease
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Personalized Music Therapy and Agitation in Dementia
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