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NCT07843043
Feasibility of a Dyadic Music-based Intervention for Persons Living With Dementia and Their Care Partners
Conditions: Dementia
Sex: All
Ages: 21 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Duke University
Location: Duke University Durham North Carolina
Summary
This study examines the feasibility, acceptability, and preliminary outcomes of a structured music-based intervention for individuals living with dementia and their family care partners.
Eligibility Criteria
Inclusion for patient:
1. Age 60 and older
2. Existing physician diagnosis of dementia or self-reported memory impairment and Telephone Montreal Cognitive Assessment (T-MoCA) score between 18-25 with a capacity to consent.
3. Care partner or PLWD reporting current or past (8-12 months) dissatisfaction with the relationship (score of 3 or less on the relationship satisfaction measure), given that one member's dissatisfaction affects the other.
4. Stable dose of psychotropic medications, sedatives/hypnotics, anti-dementia medications or opioids in the past 60 days to minimize the confounding effects of medications.
Exclusion for patient:
1. Hearing impairment (defined as inability to hear a normal speaking voice at a distance of 1-1/2 feet) to exclude those who cannot hear the music intervention.
2. Planned transition to a residential or institutional care setting in less than 3 months (to decrease attrition).
3. Currently enrolled in an interventional clinical trial for PLWD aimed to improve relationship quality (to not confound the results)
4. Receiving hospice services.
Inclusion for care partner:
1. Must reside with the patient.
2. At least 21 years.
3. Self-identify as the primary care partner
4. Able to speak and read English
5. If on psychotropic medications at the time of telephone screen must be on a stable dose of the medication for 60 days prior to enrollment.
6. Consider themselves a family member (blood or non-blood relative)
Exclusion for care partner:
1. Do not reside with patient
2. Under the age of 21 years of age
3. Is not primary care partner
4. Not able to speak and read English
5. Has not been on a stable dose of psychotropic medications for 60 days prior to enrollment.
Source: ClinicalTrials.gov (NCT07843043). StuddyBuddy aggregates publicly available trial information.