Clinical trial NCT06079216: Making Connections Thru Music
Official title: Making Connections Thru Music: A Group Music Therapy-Based Intervention for Persons With Dementia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dementia
Alzheimer Disease
Vascular Dementia
Lead sponsor: Hopeful Aging
Sponsor class: INDUSTRY
Collaborators: name: Benjamin Rose Institute on Aging
First posted: 2023-10-12
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Maximum age (years): 103
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Menorah Park Engagement Scale
timeFrame: Baseline (weeks 1-4) Treatment (weeks 5-12)
Secondary outcomes:
measure: Alzheimer's Disease Knowledge Scale
timeFrame: Baseline (weeks 1-4) Treatment (weeks 5-12)
measure: Geriatric Depression Scale- Short Form. Scores can range from zero to 15. Higher scores suggest a worse outcome
timeFrame: Baseline (weeks 1-4) Treatment (weeks 5-12)
measure: Neuropsychiatric Inventory - Nursing Home.
timeFrame: Baseline (weeks 1-4) Treatment (weeks 5-12)
Other outcomes:
Locations:
city: Winchester
country: United States
facility: The Hearthstone Institute, LLC
state: Massachusetts
Study officials:
References: