NCT04645017

Brief Summary

Intergenerational music programming has been shown to benefit both young people and older adults in terms of quality of life, social connection, and promotion of positive cross-age attitudes. During a time that older adults are facing increasing social isolation, a need exists to offer meaningful programming that can reach older adults living with memory loss. The investigators want to assess if an intergenerational music program that is delivered by adolescent music facilitators is feasible and appropriate to both the young musicians and the older adult participants. This program will be designed on Zoom but will able to be delivered in the same manner in-person, offering it flexibility to reach a variety of participants. This program is unique in that it brings together two populations who have shown to be positively affected by engaging in music - adolescents and older adults with memory loss. As a result of this work, teenage musicians will be empowered to adapt and share a music program utilizing best research practices and create new connections with an older generation. Older adults will receive a research-informed music program that will be geared to helping their musical understanding and participation, as well as an opportunity to create new connections with a younger generation. Findings from this work will generate a music program with clearly defined ingredients that can be delivered and is accepted by both its facilitators and participants, providing a foundation for future studies to assess outcomes such as social connection, cognitive benefits, and emotional well-being. This program will be built carefully utilizing stakeholder engagement from the adolescent facilitators and older adult participants. Specifically, for Aim 1 the investigators will explore the feasibility of the music program by its facilitators by conducting in-depth interviews with a sample of adolescent facilitators before, during, and after they administer the music intervention to discuss how best to adapt the program, as well as collecting observations of the older adults to confirm engagement in the program. For Aim 2 the investigators will assess its fidelity as the adolescent facilitators implement the program and are assessed for adherence and competence. For Aim 3, the investigators will assess its appropriateness, as adolescent facilitators and older adults will engage in focus groups.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 25, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

January 4, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

August 5, 2022

Status Verified

August 1, 2022

Enrollment Period

1.4 years

First QC Date

November 19, 2020

Last Update Submit

August 4, 2022

Conditions

Keywords

Music, Adolescents

Outcome Measures

Primary Outcomes (1)

  • Fidelity Review Measurement of Adherence

    Test the fidelity of young musicians delivering the music program to older adults. 80% adherence as measured via Fidelity Review forms will determine that the program was administered with fidelity. Fidelity reviews will provide data if the music facilitators consistently were able to administer the ingredients of the music intervention with adherence. A percentage will be calculated for reporting.

    Through study completion, an average of one year

Study Arms (1)

Intergenerational Music Program

EXPERIMENTAL

An intergenerational music program will be administered by adolescent musicians for older adults with early-stage cognitive decline.

Behavioral: Intergenerational Music Program

Interventions

Music activities will be lead by adolescent musicians for older adult participants.

Intergenerational Music Program

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • A decline in cognition defined as a minimum of self-reported changes in memory to a maximum of moderate Alzheimer's Disease or dementia
  • English speaking

You may not qualify if:

  • Non-english speaking
  • No self-reported or diagnosed changes in cognition, 3) younger than 65.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15201, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Jennie Dorris, MM

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Student Researcher

Study Record Dates

First Submitted

November 19, 2020

First Posted

November 25, 2020

Study Start

January 4, 2021

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

August 5, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be available. The protocol, statistical analysis plan, informed consent, and analytic code will be shared. It will be available immediately following publication with no end date. It will be shared with researchers who provide a methodologically sound proposal. It will be shared to achieve aims in the approved proposal. Proposals should be directed to jld202@pitt.edu. To gain access, data requestors will need to sign a data access agreement. Data will not be hosted on a website but will be available by contacting jld202@pitt.edu.

Locations