NCT06219148

Brief Summary

This study investigates the benefits of using telehealth services, specifically a combination of music therapy and social work support, to improve the well-being of older adults. Investigators are focusing on outcomes such as reduced loneliness, improved cognition, and how well older adults with and without dementia perceive the quality of the services received. This research is crucial because as the population ages and conditions like Alzheimer's become more prevalent, effective psychosocial interventions are needed. The collaborative telehealth approach of the intervention in this study strives to connect older adults to community and health-related services. Older adults experience challenges in accessing services related to transportation, social support, and finances. While the pandemic prompted a rapid shift of healthcare services online, including music therapy and social work, questions remain about the quality of this transition, especially for older adults who may not be familiar with or have the resources for telehealth. In this pilot study, investigators are studying music therapy and social work support through telehealth to understand how this approach can impact the well-being, cognition, and service quality for older adults, both with and without dementia. Social workers, who focus on improving well-being and addressing various needs, can leverage the therapeutic relationship built by music therapists to better identify and meet service needs. This pilot study builds on a feasibility project, which indicated that this collaborative framework is acceptable, valuable, and of interest to older adults, facilitating remote community connection. Through this research, investigators aim to evaluate the effectiveness of telehealth services for older adults to inform a future larger trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

2 active sites

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

January 12, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 23, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

March 19, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2025

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2025

Completed
Last Updated

September 3, 2025

Status Verified

August 1, 2025

Enrollment Period

1.3 years

First QC Date

January 12, 2024

Last Update Submit

August 26, 2025

Conditions

Keywords

Music TherapySocial WorkEvidence-Based PracticeQuality of LifeEmotionCognitionLonelinessCollaboration

Outcome Measures

Primary Outcomes (2)

  • Mean Change from Baseline in World Health Organization-5 (WHO-5) Well-Being Index at 6 Weeks

    A simple 5-item measure of subjective well-being (a combination of feeling good and functioning well). The participant rates each item on a 6-point scale from 0 (at no time) to 5 (all of the time); total raw score ranges from 0 (worst possible) to 25 (best possible well-being); percentage score (raw X 4) ranges from 0 (worst possible) to 100 (best possible well-being). Administered by outcome assessor by phone or Zoom at participant's preference.

    Enrollment, end of Week 6.

  • Mean Change from Baseline in WHO-5 Well-Being Index at 8 Weeks

    A simple 5-item measure of subjective well-being (a combination of feeling good and functioning well). The participant rates each item on a 6-point scale from 0 (at no time) to 5 (all of the time); total raw score ranges from 0 (worst possible) to 25 (best possible well-being); percentage score (raw X 4) ranges from 0 (worst possible) to 100 (best possible well-being). Administered by outcome assessor by phone or Zoom at participant's preference.

    Enrollment, end of Week 8.

Secondary Outcomes (9)

  • Mean Change in Self-Reported Feelings for Participants with Dementia

    Immediately before and immediately after each music therapy session.

  • Mean Change in Self-Reported Feelings for Participants without Dementia

    Immediately before and immediately after each music therapy session.

  • Mean Change from Baseline in University of California, Los Angeles (UCLA) Loneliness Scale at 6 Weeks

    Enrollment, end of Week 6.

  • Mean Change from Baseline in UCLA Loneliness Scale at 8 Weeks

    Enrollment, end of Week 8.

  • Mean Change from Baseline in Montreal Cognitive Assessment (MoCA) at 6 Weeks

    Enrollment, end of Week 6.

  • +4 more secondary outcomes

Study Arms (2)

Collaborative

EXPERIMENTAL

Social workers and music therapists work together, and information collected during music therapy informs social work wellness sessions following a protocol developed during the feasibility study. There are 3 blocks of activities, identical to the non-collaborative arm: * Weeks 1-2: enrollment, stratification, random assignment * Weeks 3-6: music therapy and social work interventions * Weeks 7-8: social work follow up.

Behavioral: Music Therapy TelehealthBehavioral: Collaborative Social Work Telehealth

Non-Collaborative

SHAM COMPARATOR

Social workers and music therapists operate independently. There are 3 blocks of activities, identical to the collaborative arm: * Weeks 1-2: enrollment, stratification, random assignment * Weeks 3-6: music therapy and social work interventions * Weeks 7-8: social work follow up.

Behavioral: Music Therapy TelehealthBehavioral: Non-Collaborative Social Work Telehealth

Interventions

Music Therapy: delivered via Zoom by a board-certified music therapist (MT-BC) 30-min 2x/week for 4 weeks (8 sessions total); follows the Clinical Practice Model, which guides customizations of various music experiences (e.g., singing, songwriting, movement, relaxation, lyric discussion, improvisation, instrument play, etc.) per participants' strengths, interests, preferences, culture, and momentary responses. Each participant works with the same MT-BC throughout the study.

Also known as: Music-based intervention (MBI)
CollaborativeNon-Collaborative

Social Work: delivered via Zoom by a licensed social worker (SW) or supervised SW graduate student 3x for 30-min: 1) after 2 weeks MT (assessment), 2) after 4 weeks MT (service referral), 3) 2-week follow-up. SWs operate independently from MT-BCs to identify possible participant service referral needs using the Aging and Memory Quality of Life Survey (AMQoL), baseline data, SW session interactions, and SW Referral Worksheet. Each participant works with the same SW throughout the study.

Also known as: Independent social work intervention, independent wellness support
Non-Collaborative

Social Work: delivered via Zoom by a licensed SW or supervised SW graduate student 3x for 30-min: 1) after 2 weeks MT (assessment), 2) after 4 weeks MT (service referral), 3) 2-week follow-up. In addition to the AMQoL, baseline data, SW session interactions, and the SW Referral Worksheet, SWs collaborate fully with MT-BCs, have full access MT session notes, and can discuss participants' needs with MT-BC to identify possible participant service referral needs. Each participant works with the same SW throughout the study.

Also known as: Integrative social work intervention, integrative wellness support
Collaborative

Eligibility Criteria

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

You may qualify if:

  • age 65 or older
  • English-speaking
  • reside in Kentucky
  • willing to receive support from the research team on how to access Zoom (as needed)
  • EITHER a) have familiarity using digital technology and/or a video conferencing app such as Zoom, FaceTime, or Facebook Messenger, OR b) have a family member or friend who can facilitate Zoom access (i.e., "helper").

You may not qualify if:

  • substance use disorder, which could present a confounding variable relative to the aims;
  • significant sensory impairment that interferes with Zoom use
  • current music therapy and/or social work case manager recipient
  • HELPERS: facilitate participation by older adults who are unfamiliar with using video conferencing technology and/or who lack consent capacity.
  • at least 18 years old
  • cognitively unimpaired
  • live with or be able to go to the older adult's residence to assist them in participating in the study.
  • under 18 years old
  • cognitively impaired
  • unable to assist the older adult in participating in the study for any reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

Saint Louis University

St Louis, Missouri, 63103, United States

Location

Related Publications (10)

  • Lam K, Lu AD, Shi Y, Covinsky KE. Assessing Telemedicine Unreadiness Among Older Adults in the United States During the COVID-19 Pandemic. JAMA Intern Med. 2020 Oct 1;180(10):1389-1391. doi: 10.1001/jamainternmed.2020.2671.

    PMID: 32744593BACKGROUND
  • Kistin C, Silverstein M. Pilot Studies: A Critical but Potentially Misused Component of Interventional Research. JAMA. 2015 Oct 20;314(15):1561-2. doi: 10.1001/jama.2015.10962. No abstract available.

    PMID: 26501530BACKGROUND
  • Gibson A, Bardach SH, Pope ND. COVID-19 and the Digital Divide: Will Social Workers Help Bridge the Gap? J Gerontol Soc Work. 2020 Aug-Oct;63(6-7):671-673. doi: 10.1080/01634372.2020.1772438. Epub 2020 Jun 5. No abstract available.

    PMID: 32500841BACKGROUND
  • Ng BP, Park C, Silverman CL, Eckhoff DO, Guest JC, Diaz DA. Accessibility and utilisation of telehealth services among older adults during COVID-19 pandemic in the United States. Health Soc Care Community. 2022 Sep;30(5):e2657-e2669. doi: 10.1111/hsc.13709. Epub 2022 Jan 6.

    PMID: 34994028BACKGROUND
  • Reschke-Hernández, A. E. (2019). A clinical practice model of music therapy to address psychosocial functioning for persons with dementia: Model development and randomized clinical crossover trial (NCT03643003). Doctoral dissertation, University of Iowa. https://doi.org/10.17077/etd.59oh-y06y

    BACKGROUND
  • Reschke-Hernández, A. E. (2021). The Clinical Practice Model for Persons with Dementia: Application to music therapy. Music Therapy Perspectives, 39(2), 133-141. https://doi.org/10.1093/mtp/miab006

    BACKGROUND
  • Reschke-Hernández, A. E., Gibson, A., Buckner, L. E., Sullivan, A. C., Posey, C., & Uecker, S. (2023). Development of a collaborative music therapy and social work telehealth framework to address the well-being of community-dwelling older adults. Research poster presented at: Alzheimer's Association International Conference, Amsterdam, Netherlands, 16-20 July 2023.

    BACKGROUND
  • Wilhelm, L., & Wilhelm, K. (2022). Telehealth music therapy services in the United States with older adults: A descriptive study. Music Therapy Perspectives. Advance online publication. https://doi.org/10.1093/mtp/miab028

    BACKGROUND
  • World Health Organization. (2017, December 7). Global action plan on the public health response to dementia 2017-2025. https://tinyurl.com/bdhm6wha

    BACKGROUND
  • World Health Organization. (2010, September 1). Framework for action on interprofessional education and collaborative practice (WHO Reference Number WHO/HRH/HPN/10.3). https://tinyurl.com/28ykjrn3

    BACKGROUND

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Alaine E Reschke-Hernandez, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR
  • Allison Gibson, PhD

    St. Louis University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Participants will remain masked to study objectives and their collaborative condition assignment. Research assistants and care providers (music therapists, social workers) will not be masked; social workers and music therapists will know if they are collaborating or not. Principal investigator Reschke-Hernandez and co-investigator Gibson will remain masked to allocation; research assistants will conduct allocation and assignment will be kept in a separate secure document that is not accessible to the PI or co-I.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: To ensure a balanced number of individuals in each study condition, a research team member will stratify participants as "with" or "without" dementia according to either their self-reported physician's diagnosis or score on the MoCA (score \<18 = "with dementia"). Participants will then be randomly assigned to either the collaborative or non-collaborative condition using a random number table.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor of Music Therapy

Study Record Dates

First Submitted

January 12, 2024

First Posted

January 23, 2024

Study Start

March 19, 2024

Primary Completion

July 14, 2025

Study Completion

July 25, 2025

Last Updated

September 3, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

This is a small pilot study. Pilot data for preliminary effect size estimating will not be publicly shared. Researchers may request de-identified data and study materials from the principal investigator.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
6 months after publication. The principal investigator will consider sharing data and study materials prior to that time frame in consultation with the study team.
Access Criteria
The principal investigator will share data, qualitative and quantitative analysis plans, and study materials with other researchers who provide a reasonable rationale for intended use, by email. Requests will be reviewed by the principal investigator Reschke-Hernandez and co-investigator Gibson.

Locations