Recruiting

Making Connections Thru Music

Sponsor:

Hopeful Aging

Code:

NCT06079216

Conditions

Dementia

Alzheimer Disease

Vascular Dementia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Volunteer Led Making Connections Thru Music

Staff Led Making Connections Thru Music

Study Details

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 ID

NCT06079216

Start date

Dec 1, 2025

Status verified date

Sep, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Apr 29, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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).

Study Design

Enrollment

196 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MCTM Intervention

Activity sessions will be led by activity volunteers

active comparator: Control

Activity sessions will be led by activity professionals

Interventions

Volunteer Led Making Connections Thru Music

Volunteer led Group music therapy-based intervention

Staff Led Making Connections Thru Music

Staff led Group music therapy-based intervention

Primary outcome measure

  • Menorah Park Engagement Scale [ Time Frame: Baseline (weeks 1-4) Treatment (weeks 5-12) ]

Central Contacts and Locations

Locations

Hopeful Aging

Recruiting

Winchester, Massachusetts, United States, 01890

Contacts

Principal Investigator:

Gregg Gorzelle, MA

The Hearthstone Institute, LLC

Recruiting

Winchester, Massachusetts, United States, 01890

Contacts

More Information

Sponsor

Hopeful Aging

Last update posted

Sep 15, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-16. This information was provided to ClinicalTrials.gov by Hopeful Aging on 2026-09-15.