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Making Connections Thru Music (MCTM)

Primary Purpose

Dementia, Alzheimer Disease, Vascular Dementia

Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Volunteer Led Making Connections Thru Music
Staff Led Making Connections Thru Music
Sponsored by
The Hearthstone Institute, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia

Eligibility Criteria

18 Years - 103 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • The Hearthstone Institute, LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MCTM Intervention

Control

Arm Description

Activity sessions will be led by activity volunteers

Activity sessions will be led by activity professionals

Outcomes

Primary Outcome Measures

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. 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

Alzheimer's Disease Knowledge Scale
30-item scale to measure knowledge of Alzheimer's Disease.
Geriatric Depression Scale- Short Form
This is a 15-item measure of depression in older adults that is conducted via direct interview.
Neuropsychiatric Inventory - Nursing Home
The Neuropsychiatric Inventory-Nursing Home is a comprehensive assessment of psychopathology in persons with dementia, focused on people residing in nursing homes.

Full Information

First Posted
October 6, 2023
Last Updated
October 6, 2023
Sponsor
The Hearthstone Institute, LLC
Collaborators
Benjamin Rose Institute on Aging
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1. Study Identification

Unique Protocol Identification Number
NCT06079216
Brief Title
Making Connections Thru Music
Acronym
MCTM
Official Title
Making Connections Thru Music: A Group Music Therapy-Based Intervention for Persons With Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2024 (Anticipated)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Hearthstone Institute, LLC
Collaborators
Benjamin Rose Institute on Aging

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Alzheimer Disease, Vascular Dementia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
196 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MCTM Intervention
Arm Type
Experimental
Arm Description
Activity sessions will be led by activity volunteers
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Activity sessions will be led by activity professionals
Intervention Type
Behavioral
Intervention Name(s)
Volunteer Led Making Connections Thru Music
Intervention Description
Volunteer led Group music therapy-based intervention
Intervention Type
Behavioral
Intervention Name(s)
Staff Led Making Connections Thru Music
Intervention Description
Staff led Group music therapy-based intervention
Primary Outcome Measure Information:
Title
Menorah Park Engagement Scale
Description
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.
Time Frame
Baseline (weeks 1-4) Treatment (weeks 5-12)
Secondary Outcome Measure Information:
Title
Alzheimer's Disease Knowledge Scale
Description
30-item scale to measure knowledge of Alzheimer's Disease.
Time Frame
Baseline (weeks 1-4) Treatment (weeks 5-12)
Title
Geriatric Depression Scale- Short Form
Description
This is a 15-item measure of depression in older adults that is conducted via direct interview.
Time Frame
Baseline (weeks 1-4) Treatment (weeks 5-12)
Title
Neuropsychiatric Inventory - Nursing Home
Description
The Neuropsychiatric Inventory-Nursing Home is a comprehensive assessment of psychopathology in persons with dementia, focused on people residing in nursing homes.
Time Frame
Baseline (weeks 1-4) Treatment (weeks 5-12)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
103 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Facility Information:
Facility Name
The Hearthstone Institute, LLC
City
Winchester
State/Province
Massachusetts
ZIP/Postal Code
01890
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Making Connections Thru Music

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