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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
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

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

60 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 21, 2014
    Last Updated
    September 24, 2019
    Sponsor
    University Health Network, Toronto
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    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

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