Making Connections Thru Music

NCT ID: NCT06079216

Last Updated: 2025-01-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 196 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2025-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MCTM Intervention

Activity sessions will be led by activity volunteers

Group Type: EXPERIMENTAL

Volunteer Led Making Connections Thru Music

Intervention Type: BEHAVIORAL

Volunteer led Group music therapy-based intervention

Control

Activity sessions will be led by activity professionals

Group Type: ACTIVE_COMPARATOR

Staff Led Making Connections Thru Music

Intervention Type: BEHAVIORAL

Staff led Group music therapy-based intervention

Interventions

Volunteer Led Making Connections Thru Music

Volunteer led Group music therapy-based intervention

Intervention Type: BEHAVIORAL

Staff Led Making Connections Thru Music

Staff led Group music therapy-based intervention

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 103 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Benjamin Rose Institute on Aging

OTHER

Sponsor Role: collaborator

Hopeful Aging

INDUSTRY

Sponsor Role: lead

Responsible Party

Gregg Gorzelle

Associate Director of Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Hearthstone Institute, LLC

Winchester, Massachusetts, United States

Countries

United States

Other Identifiers

HearthstoneI

Identifier Type: -

Identifier Source: org_study_id