Making Connections Thru Music

NCT06079216 | Not Yet Recruiting

• 1 other identifier: HearthstoneI
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief Summary

Healthcare systems around the world, including within the United States, have long-established shortages of trained caregivers. The American Health Care Association states that "the health care system has experienced a shortage of trained caregivers for critical roles for some time." This scarcity directly impacts the 45,800 Long-Term Care (LTC) communities throughout the U.S. Concurrent with this staff shortage, more than half of LTC residents have some form of dementia. These two issues create a serious public health concern, since dementia is associated with a variety of behavioral expressions, such as aggression, anxiety, and agitation. Behavioral expressions of dementia can be successfully managed with the use of tailored, psychosocial interventions and communication support. Unfortunately, existing staff shortages make the facilitation of such interventions challenging. One powerful and often-overlooked approach to ameliorating staffing shortages involves the utilization of retired volunteers to facilitate interventions for persons with dementia (PWD). Based on the nearly universal love of music and a promising pilot study, the product to be developed and tested in this STTR will build upon the combined prior work of the Principal Investigators. Making Connections Thru Music (MCTM), an urgently needed product, will enable retired volunteers to facilitate an evidence-based music and discussion intervention with PWD. MCTM aims to improve engagement, enhance quality of life, and reduce behavioral expressions in PWD. The intervention will consist of two main components: (1) a comprehensive online training course for volunteers, which will provide a general overview of dementia, demonstrate effective communication strategies to use with PWD, and instruct volunteers to effectively facilitate MCTM sessions, and (2) an app containing a structured MCTM intervention protocol and toolkit, which will be the means by which volunteers facilitate MCTM. MCTM will be marketed to LTC communities.

Conditions

Dementia; Alzheimer Disease; Vascular Dementia

Outcome Measures

Primary Outcomes (1)

• Menorah Park Engagement Scale

  The MPES is an observational scale that measures four types of engagement: Constructive Engagement, Passive Engagement, Distracted Engagement, and Non-Engagement / Apathy The MPES also measures Pleasure, defined as clearly observable smiling or laughing. For each item, the minimum possible value is 0 (not at all) and the maximum possible value is 2 (more than half of the time). For Constructive Engagement, Passive Engagement, and Pleasure, higher scores would represent a better outcome. For Distracted Engagement and Non-Engagement, higher scores would represent a worse outcome.

  Baseline (weeks 1-4) Treatment (weeks 5-12)

Secondary Outcomes (3)

• Alzheimer's Disease Knowledge Scale

  Baseline (weeks 1-4) Treatment (weeks 5-12)

• Geriatric Depression Scale- Short Form. Scores can range from zero to 15. Higher scores suggest a worse outcome

  Baseline (weeks 1-4) Treatment (weeks 5-12)

• Neuropsychiatric Inventory - Nursing Home.

  Baseline (weeks 1-4) Treatment (weeks 5-12)

Study Arms (2)

MCTM Intervention

EXPERIMENTAL

Activity sessions will be led by activity volunteers

Behavioral: Volunteer Led Making Connections Thru Music

Control

ACTIVE COMPARATOR

Activity sessions will be led by activity professionals

Behavioral: Staff Led Making Connections Thru Music

Interventions

Volunteer Led Making Connections Thru Music BEHAVIORAL

Volunteer led Group music therapy-based intervention

MCTM Intervention

Staff Led Making Connections Thru Music BEHAVIORAL

Staff led Group music therapy-based intervention

Control

Eligibility Criteria

• Age: 18 Years - 103 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteers must be aged 55+ and speak/read conversational English.
• Staff participants must be at least 18 years old, work within a residential care facility participating in the study, and speak and read English.

You may not qualify if:

• Volunteers will be excluded if they are diagnosed with dementia based on self-report and/or if they score 23 or lower on theMini Mental State Exam (MMSE; Folstein et al., 1975). Such a score would be indicative of possible cognitive impairment.
• Staff members will be excluded if they work third shift only. PWD Residents with dementia must be diagnosed with dementia (any type), score 10 or above on the MMSE, be aged 65+, and speak/read conversational English.
• PWD will be excluded if they show signs of rapid physical or cognitive decline (based upon staff report or as evidenced by information gained during screening).

Sponsors & Collaborators

• Hopeful Aging: lead
• Benjamin Rose Institute on Aging: collaborator

Study Sites (1)

The Hearthstone Institute, LLC

Winchester, Massachusetts, 01890, United States

Location

MeSH Terms

Conditions

Dementia; Alzheimer Disease; Dementia, Vascular

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director of Research

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: October 12, 2023
• Study Start: July 1, 2025
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: January 16, 2025

Record last verified: 2025-01

Locations

US (1)