DementiaMCTMNCT06079216
Making Connections Thru Music
A study testing Volunteer Led Making Connections Thru Music and Staff Led Making Connections Thru Music in people with Dementia and Alzheimer Disease, run by Hopeful Aging at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 103 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia, Alzheimer Disease, Vascular Dementia
- What is being tested?
- Volunteer Led Making Connections Thru Music and Staff Led Making Connections Thru Music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Dec 2025to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 103 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Hopeful Aging
Winchester, Massachusetts, 01890
Michael Skrajner, 440-477-7881, mike@hopefulaging.com
Gregg Gorzelle, MA
- Recruiting
The Hearthstone Institute, LLC
Winchester, Massachusetts, 01890
Michael Skrajner, MA, 4404777881, skrajner@thehearth.org
About this study
Official title: Making Connections Thru Music: A Group Music Therapy-Based Intervention for Persons With Dementia
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
- Being tested
- Volunteer Led Making Connections Thru Music, Staff Led Making Connections Thru Music
- Medical subject headings
- Dementia, Alzheimer Disease, Dementia, Vascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volunteer Led Making Connections Thru MusicBehavioural
Volunteer led Group music therapy-based intervention
Staff Led Making Connections Thru MusicBehavioural
Staff led Group music therapy-based intervention
| Study group | Role | What they receive |
|---|---|---|
| MCTM Intervention | Experimental | Activity sessions will be led by activity volunteers Receives: Behavioral: Volunteer Led Making Connections Thru Music |
| Control | Active comparator | Activity sessions will be led by activity professionals Receives: Behavioral: Staff Led Making Connections Thru Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
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. For each item, the minimum possible value is 0 (not at all) and the maximum possible value is 2 (more than half of the time). For Constructive Engagement, Passive Engagement, and Pleasure, higher scores would represent a better outcome. For Distracted Engagement and Non-Engagement, higher scores would represent a worse outcome.
Measured: Baseline (weeks 1-4) Treatment (weeks 5-12)
Secondary outcomes (3)
Alzheimer's Disease Knowledge Scale
30-item scale to measure knowledge of Alzheimer's Disease. The range of score is zero to 30. A higher score indicates a better outcome.
Measured: Baseline (weeks 1-4) Treatment (weeks 5-12)
Geriatric Depression Scale- Short Form. Scores can range from zero to 15. Higher scores suggest a worse outcome
This is a 15-item measure of depression in older adults that is conducted via direct interview.
Measured: Baseline (weeks 1-4) Treatment (weeks 5-12)
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. Researchers typically use the frequency x severity (FxS) total score on this measure. We will be using this score in this study. The FxS score ranges from 0 to 120, with a higher score indicating a worse outcome.
Measured: Baseline (weeks 1-4) Treatment (weeks 5-12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start1 Dec 2025
- Primary completion29 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopeful Aging
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Benjamin Rose Institute on Aging
- Responsible party
- Principal investigator, Gregg Gorzelle, Hopeful Aging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06079216
- Sponsor's protocol ID
- HearthstoneI
- Acronym
- MCTM
- Status last verified
- Sep 2026
- First submitted
- 6 Oct 2023
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Making Connections Thru Music: A Group Music Therapy-Based Intervention for Persons With Dementia
- ClinicalTrials.gov ID
- NCT06079216
- Acronym / sponsor ID
- MCTM / HearthstoneI
- Conditions
- Dementia, Alzheimer Disease, Vascular Dementia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Hopeful AgingIndustry (pharma, biotech, devices)
- Collaborators
- Benjamin Rose Institute on Aging
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 29 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 12 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MCTM Intervention | Experimental | Behavioral: Volunteer Led Making Connections Thru MusicActivity sessions will be led by activity volunteers |
| Control | Active comparator | Behavioral: Staff Led Making Connections Thru MusicActivity sessions will be led by activity professionals |
Who may qualify
- Ages
- 18 to 103 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Volunteer Led Making Connections Thru MusicVolunteer led Group music therapy-based intervention | Behavioural | MCTM Intervention |
| Staff Led Making Connections Thru MusicStaff led Group music therapy-based intervention | Behavioural | Control |
Primary outcome
Menorah Park Engagement Scale
Time frame: 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. For each item, the minimum possible value is 0 (not at all) and the maximum possible value is 2 (more than half of the time). For Constructive Engagement, Passive Engagement, and Pleasure, higher scores would represent a better outcome. For Distracted Engagement and Non-Engagement, higher scores would represent a worse outcome.
3 secondary outcomes
Alzheimer's Disease Knowledge Scale
Time frame: Baseline (weeks 1-4) Treatment (weeks 5-12)
Geriatric Depression Scale- Short Form. Scores can range from zero to 15. Higher scores suggest a worse outcome
Time frame: Baseline (weeks 1-4) Treatment (weeks 5-12)
Neuropsychiatric Inventory - Nursing Home.
Time frame: Baseline (weeks 1-4) Treatment (weeks 5-12)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volunteer Led Making Connections Thru Music and Staff Led Making Connections Thru Music in people with Dementia and Alzheimer Disease, run by Hopeful Aging at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menorah Park Engagement Scale (time frame: Baseline (weeks 1-4) Treatment (weeks 5-12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.