Dementia Clinical Trial
— Melo-SWellOfficial 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
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | June 30, 2025 |
Est. primary completion date | October 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Kentucky | Lexington | Kentucky |
United States | Saint Louis University | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Alaine E Hernandez, PhD | American Music Therapy Association |
United States,
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. — View 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. — View 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. — View 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. — View 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
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
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.
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
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
World Health Organization. (2017, December 7). Global action plan on the public health response to dementia 2017-2025. https://tinyurl.com/bdhm6wha
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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 | Mean Change in Self-Reported Feelings for Participants with Dementia | Administered by music therapists. For participants who score less than 18 on the Montreal Cognitive Assessment (MoCA): The Dementia Mood Picture Test (DMPT) measures self-reported feelings of persons with mild, moderate, or severe dementia using simple, enlarged face drawings with verbal descriptors for 6 emotions: good mood, bad mood, happy, sad, angry, and worried. The person with dementia rates each emotion on a 3-point scale from 0 (do not feel that emotion) to 2 (feel that emotion a lot); total score ranges from 0 (most negative) to 12 (most positive; with negative valence emotions reverse-scored). | Immediately before and immediately after each music therapy session. | |
Secondary | Mean Change in Self-Reported Feelings for Participants without Dementia | Administered by music therapists. For participants who score 18 or greater on the MoCA: analogous Likert-type scale for the same 6 DMPT items: good mood, bad mood, happy, sad, angry, and worried, scored from 0 (do not feel that emotion) to 6 (feel that emotion a lot); total score ranges from 0 (most negative) to 36 (most positive). | Immediately before and immediately after each music therapy session. | |
Secondary | Mean Change from Baseline in University of California, Los Angeles (UCLA) Loneliness Scale at 6 Weeks | The UCLA Loneliness Scale (Version 3) is a 20-item scale designed to measure subjective feelings of loneliness and social isolation. Participants rate each item on a 4-point scale from 1 (Never) to 4 (Often). Total score ranges from 20 (lower loneliness) to 80 (higher loneliness). Administered by outcome assessor by phone or Zoom at participant's preference. | Enrollment, end of Week 6. | |
Secondary | Mean Change from Baseline in UCLA Loneliness Scale at 8 Weeks | The UCLA Loneliness Scale (Version 3) is a 20-item scale designed to measure subjective feelings of loneliness and social isolation. Participants rate each item on a 4-point scale from 1 (Never) to 4 (Often). Total score ranges from 20 (lower loneliness) to 80 (higher loneliness). Administered by outcome assessor by phone or Zoom at participant's preference. | Enrollment, end of Week 8. | |
Secondary | Mean Change from Baseline in Montreal Cognitive Assessment (MoCA) at 6 Weeks | Cognitive screening tool with scores ranging from 0 (greatly impaired) to 30 (unimpaired). The researchers will use the Audio-Visual Conference version as a brief estimate of change in cognitive status over the course of the study. Those who score less than 18 will be labeled as "with dementia" for the purposes of random assignment, and the researchers will use the following descriptive severity categories: > 25 = no impairment, 18-25 = mild impairment, 10-17= moderate impairment, < 10 = severe impairment. Administered by outcome assessor by Zoom. | Enrollment, end of Week 6. | |
Secondary | Program Evaluation Total Score | The researchers will use a 12-item Quality Questionnaire concerning quality, willingness to try, and helpfulness of music therapy, social work, telehealth, and the overall program. Each item uses a 5-point Likert-type scale from 1 (Poor/extremely unwilling/extremely unhelpful) to 5 (Excellent/extremely willing/extremely helpful). Total score ranges from 12 (worst) to 60 (best). Administered by outcome assessor by phone or Zoom at participant's preference. | Within 1 week of final social work session. | |
Secondary | Program Evaluation Quality Score | The researchers will analyze 4 quality items from the Quality Questionnaire concerning quality of music therapy, quality of social work, quality of telehealth, and quality of the overall program. Each item uses a 5-point Likert-type scale from 1 (Poor) to 5 (Excellent). Total score for quality ranges from 4 (poorest quality) to 20 (best quality). Administered by outcome assessor by phone or Zoom at participant's preference. | Within 1 week of final social work session. | |
Secondary | Program Evaluation Willingness Score | The researchers will analyze 4 quality items from the Quality Questionnaire concerning willingness to try music therapy, social work, telehealth, and the overall program in the future. Each item uses a 5-point Likert-type scale from 1 (extremely unwilling) to 5 (extremely willing). Total score for willingness ranges from 4 (most unwilling) to 20 (most willing). Administered by outcome assessor by phone or Zoom at participant's preference. | Within 1 week of final social work session. | |
Secondary | Program Evaluation Helpfulness Score | The researchers will analyze 4 quality items from the Quality Questionnaire concerning helpfulness of music therapy, social work, telehealth, and the overall program. Each item uses a 5-point Likert-type scale from 1 (extremely unhelpful) to 5 (extremely helpful). Total score for helpfulness ranges from 4 (most unhelpful) to 20 (most helpful). Administered by outcome assessor by phone or Zoom at participant's preference. | Within 1 week of final social work session. |
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