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A Music-Based Mobile App for People Living With Alzheimer's Disease and Related Dementias (ADRD)

Sponsor
Autotune Me LLC (Other)
Overall Status
Recruiting
CT.gov ID
NCT06140342
Collaborator
University of Pennsylvania (Other), National Institute on Aging (NIA) (NIH)
20
Enrollment
1
Location
17.1
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this pilot is to develop a mobile application that detects physiological measures of individuals with Alzheimer's disease and related dementias and triggers auto-play of personalized songs in a wearable device. The investigators will test the feasibility and acceptability of the app. This app may be an important tool to include in daily caregiving in a home setting by extending established benefits of music therapy for people with Alzheimer's disease and related dementias.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Feasibility study of music-based mobile app

Study Design

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
A Music-Based Mobile App to Combat Neuropsychiatric Symptoms in People Living With ADRD
Actual Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Jan 1, 2025

Outcome Measures

Primary Outcome Measures

  1. Usability of mobile app [2 weeks]

    Dyads of caregivers of people with dementia and their caregivers will wear a smartwatch and test the music-based mobile app for two weeks. The person with dementia will wear the smartwatch that will connect to the mobile app for 2 weeks. Caregivers will be asked to complete a daily checklist of their care recipients' behaviors for two weeks. Participants will complete the Usefulness, Satisfaction and Ease of Use questionnaire that describes the usability of the mobile app. The minimum score is 30 while the maximum score is 240. The higher the score means the usability of the app is more acceptable.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

Inclusion Criteria for person with dementia

  • A person with ADRD exhibits neuropsychiatric symptoms of dementia such as agitation, restlessness, depressed mood, etc.

  • Stability with or without psychotropic or anti-depressant medications

  • Ability to hear with or without an assistive device

Inclusion Criteria for Caregivers

  • Family or close friend caregiver of persons with dementia

  • Must be able to read and write in basic English

Exclusion Criteria for all participants

  • Inadequate hearing

  • History of psychosis or other mental disorders other than depression

  • Presence of substance or alcohol abuse

Contacts and Locations

Locations

Site City State Country Postal Code
1 Autotune Me, LLC Brooklyn New York United States 11224

Sponsors and Collaborators

  • Autotune Me LLC
  • University of Pennsylvania
  • National Institute on Aging (NIA)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Autotune Me LLC
ClinicalTrials.gov Identifier:
NCT06140342
Other Study ID Numbers:
  • 3-P30-AG-073105-02 SUPPLEMENT
First Posted:
Nov 20, 2023
Last Update Posted:
Nov 24, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Dementia
Depression

Study Results

No Results Posted as of Nov 24, 2023