Muziek voor thuiswonende mensen met dementie en hun mantelzorgers: een gerandomiseerde studie
- Conditions
- Dementia
- Registration Number
- NL-OMON27014
- Lead Sponsor
- Pending
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 460
Adult people diagnosed with dementia (mild to moderate, assessed by the Global Deterioration Scale for assessment of primary degenerative dementia; <=5) by a physician
-Living at home together with a caregiver
-Family caregiver is willing to attend the music intervention twice a day
-Enough knowledge of the Dutch language by patient and caregivers
-Written informed consent by participants (if they are able to) or legally authorized representatives
-Hearing impairments (if the participant is unable to enjoy listening to music due to hearing problems. A hearing aid is not a problem, as long as the participant can listen to music with pleasure)
-Presence of delirium
-Starting using new psychotropic drugs <6 weeks before inclusion
-Life expectancy <6 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference from baseline to post-intervention neuropsychiatric symptoms-score defined with the Neuropsychiatric Inventory (NPI) in people with dementia
- Secondary Outcome Measures
Name Time Method In people with dementia<br>-Positive and negative affect (PANAS)<br>-Dementia quality of life instrument (DQI)<br>-Cornell Scale for Depression in Dementia (CSDD)<br>-Independence in activities of daily living (ADL KATZ)<br>-Independence in instrumental activities of daily living (iADL)<br>-Medication changes in prescriptions of analgesics and psychotropic drugs (coded as defined daily dosage – DDD)<br>-Use of respite care or admission to a nursing home<br>-Total costs, incremental costs per patient with problem behavior successfully reduced, and incremental costs per quality-adjusted life year (QALY) gained<br>In family caregivers<br>-Person’s ‘sense of competence’ which is an important factor in their wellbeing (SCQ)-short form<br>-Distress scale of the NPI<br>-Physical Health (SF-36)<br>