A Music-Based Mobile App for People Living With ADRD

November 17, 2023 updated by: Autotune Me LLC

A Music-Based Mobile App to Combat Neuropsychiatric Symptoms in People Living With ADRD

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. We 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • Brooklyn, New York, United States, 11224
        • Recruiting
        • Autotune Me, LLC
        • Contact:
          • Kendra Ray, PhD, MPH, MBA
          • Phone Number: 347-636-7157

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Older adults 65+.with dementia who demonstrates symptoms of dementia such as agitation or depressive symptoms.

Caregiver of a person with dementia

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usability of mobile app
Time Frame: 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. They will complete the USE questionnaire that describes the usability of the mobile app.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Autotune Me LLC

Collaborators

University of Pennsylvania
National Institute on Aging (NIA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

November 3, 2023

First Submitted That Met QC Criteria

November 17, 2023

First Posted (Actual)

November 20, 2023

Study Record Updates

Last Update Posted (Actual)

November 20, 2023

Last Update Submitted That Met QC Criteria

November 17, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3-P30-AG-073105-02 SUPPLEMENT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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