Clinical trial NCT06219148: Music Therapy and Social Work Telehealth for Older Adult Well-Being
Official title: A Pilot Study to Evaluate the Effectiveness of a Collaborative Music Therapy and Social Work Telehealth Framework to Address the Well-Being of Community- Dwelling Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aging Well
Dementia
Telemedicine
Keywords: Music Therapy
Social Work
Evidence-Based Practice
Quality of Life
Emotion
Cognition
Loneliness
Collaboration
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: American Music Therapy Association
First posted: 2024-01-23
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: The goal of this quantitative pilot study is to evaluate the effectiveness of a collaborative music therapy and social work telehealth framework for community-dwelling older adults with and without dementia with regards to their emotions, well-being, cognition, and perceived service quality. This pilot study builds on a feasibility study that field tested logistics and provided proof-of-concept of the novel telehealth framework. Specifically, the feasibility study evaluated the acceptability, barriers, and facilitators of this framework for older adults with and without dementia. Both music-based interventions were grounded in the person-centered Clinical Practice Model for Persons with Dementia, which provides guidelines for adjusting the degree of support and challenge offered to an individual. The investigators developed a collaborative social work referral worksheet. The investigators conducted semi-structured qualitative interviews with participants and care partners, who offered input about all aspects of the study. The investigators also refined recruitment, data collection, protocol training, and intervention processes. This pilot study builds on this past feasibility work.

Older adults often experience changes in health, finances, and social support which impede community involvement. Social distancing surrounding COVID-19 exacerbated such hurdles and enhanced risk for loneliness, depression, and cognitive decline. Although many services including music therapy and social work transitioned from in-person to telehealth during the pandemic, the rapid shift suggests that innovation occurred reactively, without sufficient time to evaluate the quality or effectiveness of this service delivery model. Telehealth is likely to continue to be a component of the music therapy profession and more broadly in healthcare. With thoughtful and systematic development to bridge the digital divide, telehealth may offer some benefit to community-dwelling older adults. This goal may be accomplished through interprofessional collaboration. Music therapists can address psychosocial needs through a variety of flexible and age-appropriate music experiences, while social workers have expertise to reach isolated individuals and connect them to appropriate supports. This pilot study advances a line of research to test a novel telehealth framework that integrates social work and music therapy to promote older adult well-being.

In this quantitative pilot study, the investigators will test methods and procedures that will be used in a future larger clinical trial to enhance the rigor and reproducibility of this research. The objectives of this pilot study are to examine the effects of the collaborative telehealth framework on older adults' well-being (primary aim), cognition, loneliness, perception of service quality, and (in response to music therapy) emotions, and to gather preliminary data for effect size estimation. Participants and interventionists will be invited to engage in a semi-structured qualitative interview at the conclusion of the study to inform further optimization of the collaborative telehealth framework. Participants have the option to use their own or borrow equipment (iPads). To reach those with limited resources, there will be 2 iPads with cellular data available to ship to enable study participation. Participants will be community-dwelling older adults with and without dementia. All participants will receive music therapy via telehealth and social work wellness sessions via telehealth. Collaboration is the key difference in the levels of independent variable: participants will be randomly assigned to either a collaborative condition, or non-collaborative condition. In the collaborative condition, information collected during music therapy will inform social work wellness sessions following a protocol developed during the feasibility study. In the non-collaborative condition, social workers and music therapists will operate telehealth services independently.

Eligibility criteria: Inclusion Criteria:

* 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").

Exclusion Criteria:

* 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.

Helper Inclusion Criteria:

* 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.

Helper Exclusion Criteria:

* under 18 years old
* cognitively impaired
* unable to assist the older adult in participating in the study for any reason

Primary outcomes:
measure: Mean Change from Baseline in World Health Organization-5 (WHO-5) Well-Being Index at 6 Weeks
timeFrame: Enrollment, end of Week 6.
measure: Mean Change from Baseline in WHO-5 Well-Being Index at 8 Weeks
timeFrame: Enrollment, end of Week 8.
Secondary outcomes:
measure: Mean Change in Self-Reported Feelings for Participants with Dementia
timeFrame: Immediately before and immediately after each music therapy session.
measure: Mean Change in Self-Reported Feelings for Participants without Dementia
timeFrame: Immediately before and immediately after each music therapy session.
measure: Mean Change from Baseline in University of California, Los Angeles (UCLA) Loneliness Scale at 6 Weeks
timeFrame: Enrollment, end of Week 6.
measure: Mean Change from Baseline in UCLA Loneliness Scale at 8 Weeks
timeFrame: Enrollment, end of Week 8.
measure: Mean Change from Baseline in Montreal Cognitive Assessment (MoCA) at 6 Weeks
timeFrame: Enrollment, end of Week 6.
measure: Program Evaluation Total Score
timeFrame: Within 1 week of final social work session.
measure: Program Evaluation Quality Score
timeFrame: Within 1 week of final social work session.
measure: Program Evaluation Willingness Score
timeFrame: Within 1 week of final social work session.
measure: Program Evaluation Helpfulness Score
timeFrame: Within 1 week of final social work session.
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
Study officials:
affiliation: University of Kentucky
name: Alaine E Reschke-Hernandez, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Louis University
name: Allison Gibson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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
citation: 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
citation: Reschke-Hernández, A. E., Gibson, A., Buckner, L. E., Sullivan, A. C., Posey, C., &amp; 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.
citation: Wilhelm, L., &amp; 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
citation: World Health Organization. (2017, December 7). Global action plan on the public health response to dementia 2017-2025. https://tinyurl.com/bdhm6wha
citation: 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