Clinical trial for Dementia
Official title Protocolized Receptive Music Intervention to Reduce Care Refusal in Nursing Home Residents With Major Neurocognitive Disorders
ClinicalTrials.gov ID: NCT07730957
What this study is testing
- What it's testing
- The goal of this randomized study is to find out whether using a structured, protocolized music program (MUSIC CARE©) during daily hygiene care can reduce care refusal in older adults with dementia (memory and thinking conditions) who live in nursing homes (EHPADs). What is "care refusal"?
- Time commitment: about 18 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- RESIDENT ELIGIBILITY
- Living in a LNA Santé EHPAD (nursing home) as a permanent resident for at least 3 months
- Diagnosed Alzheimer's disease or a related disorder, or confirmed cognitive decline shown by a Mini-Mental State Examination (MMSE - a short memory...
- Showing care refusal behavior, defined as an Agitation/Aggression item score on the NPI-ES scale (frequency × severity) greater than or equal to 4 at...
- Resident and/or their legal representative or trusted person has given written consent to participate
You likely can't join if
- Uncompensated hearing loss with sensory isolation (unable to benefit from music therapy)
- Documented end-of-life status in the medical record CAREGIVER ELIGIBILITY Inclusion Criteria (Caregivers):
- Adult (18 years of age or older)
- Working in the care unit of an enrolled resident and performing hygiene/nursing care (bathing)
- Able to read and write French
- Affiliated to a French social security scheme
See the full eligibility criteria
- RESIDENT ELIGIBILITY
- Living in a LNA Santé EHPAD (nursing home) as a permanent resident for at least 3 months
- Diagnosed Alzheimer's disease or a related disorder, or confirmed cognitive decline shown by a Mini-Mental State Examination (MMSE - a short memory and thinking test) score of 24 or less within the past 12 months...
- Showing care refusal behavior, defined as an Agitation/Aggression item score on the NPI-ES scale (frequency × severity) greater than or equal to 4 at the time of inclusion
- Resident and/or their legal representative or trusted person has given written consent to participate
- Affiliated to a French social security scheme
- Uncompensated hearing loss with sensory isolation (unable to benefit from music therapy)
- Documented end-of-life status in the medical record CAREGIVER ELIGIBILITY Inclusion Criteria (Caregivers):
- Adult (18 years of age or older)
- Working in the care unit of an enrolled resident and performing hygiene/nursing care (bathing)
- Able to read and write French
- Affiliated to a French social security scheme
- Has given written consent to participate Exclusion Criteria (Caregivers):
- Employment contract shorter than the resident's 3-month study follow-up period (i.e., unable to complete all 3 caregiver assessments)
- Unable to provide informed consent to participate
- Under legal protection as defined by Article 1121-8 of the French Public Health Code (under legal guardianship or deprived of liberty)
- Not affiliated to a French social security scheme
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Garches, France
- La Celle-Saint-Cloud, France
- La Ferté-sous-Jouarre, France
- Nantes, France
- Pacé, France
- Pessac, France
- Saint-Rogatien, France
- Salon-de-Provence, France
- Vannes, France
- Villenave-d'Ornon, France
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here - ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 18 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Garches, France; La Celle-Saint-Cloud, France; La Ferté-sous-Jouarre, France; Nantes, France; Pacé, France and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.