MCTM: Making Connections Thru Music

Sponsor
The Hearthstone Institute, LLC (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06079216
Collaborator
Benjamin Rose Institute on Aging (Other)
196
1
2
12.9
15.1

Study Details

Study Description

Brief Summary

Healthcare systems around the world, including within the United States, have long-established shortages of trainedcaregivers (WHO, 2016; Jones, Liu, Murfield, & Moyle, 2020). The American Health Care Association (2019) states that"the health care system has experienced a shortage of trained caregivers for critical roles for some time." This scarcitydirectly impacts the 45,800 Long-Term Care (LTC) communities throughout the U.S. (Harris-Kojetin et al, 2016).

Concurrent with this staff shortage, more than half of LTC residents have some form of dementia (Alzheimer's Association,2019). These two issues create a serious public health concern, since dementia is associated with a variety of behavioralexpressions, such as aggression, anxiety, and agitation (Cummings, 1997). Behavioral expressions of dementia can besuccessfully managed with the use of tailored, psychosocial interventions and communication support (Vernooij-Dassen etal., 2010; Fazio et al., 2018). 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 retiredvolunteers 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Volunteer Led Making Connections Thru Music
  • Behavioral: Staff Led Making Connections Thru Music
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
196 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Making Connections Thru Music: A Group Music Therapy-Based Intervention for Persons With Dementia
Anticipated Study Start Date :
Sep 1, 2024
Anticipated Primary Completion Date :
Sep 30, 2025
Anticipated Study Completion Date :
Sep 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: MCTM Intervention

Activity sessions will be led by activity volunteers

Behavioral: Volunteer Led Making Connections Thru Music
Volunteer led Group music therapy-based intervention

Active Comparator: Control

Activity sessions will be led by activity professionals

Behavioral: Staff Led Making Connections Thru Music
Staff led Group music therapy-based intervention

Outcome Measures

Primary Outcome Measures

  1. Menorah Park Engagement Scale [Baseline (weeks 1-4) Treatment (weeks 5-12)]

    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. 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. The Menorah Park Engagement Scale measures four types of engagement. Constructive Engagement, Passive Engagement, Other Engagement, and Non-Engagement. It also measures pleasure.

Secondary Outcome Measures

  1. Alzheimer's Disease Knowledge Scale [Baseline (weeks 1-4) Treatment (weeks 5-12)]

    30-item scale to measure knowledge of Alzheimer's Disease.

  2. Geriatric Depression Scale- Short Form [Baseline (weeks 1-4) Treatment (weeks 5-12)]

    This is a 15-item measure of depression in older adults that is conducted via direct interview.

  3. Neuropsychiatric Inventory - Nursing Home [Baseline (weeks 1-4) Treatment (weeks 5-12)]

    The Neuropsychiatric Inventory-Nursing Home is a comprehensive assessment of psychopathology in persons with dementia, focused on people residing in nursing homes.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 103 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Hearthstone Institute, LLC Winchester Massachusetts United States 01890

Sponsors and Collaborators

  • The Hearthstone Institute, LLC
  • Benjamin Rose Institute on Aging

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The Hearthstone Institute, LLC
ClinicalTrials.gov Identifier:
NCT06079216
Other Study ID Numbers:
  • HearthstoneI
First Posted:
Oct 12, 2023
Last Update Posted:
Oct 12, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 12, 2023