No registrations found.
ID
Source
Brief title
Health condition
Dementia
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference from baseline to post-intervention neuropsychiatric symptoms-score defined with the Neuropsychiatric Inventory (NPI) in people with dementia
Secondary outcome
In people with dementia
- Positive and negative affect (PANAS)
- Dementia quality of life instrument (DQI)
- Cornell Scale for Depression in Dementia (CSDD)
- Independence in activities of daily living (ADL KATZ)
- Independence in instrumental activities of daily living (iADL)
- Medication changes in prescriptions of analgesics and psychotropic drugs (coded as defined daily dosage – DDD)
- Use of respite care or admission to a nursing home
- Total costs, incremental costs per patient with problem behavior successfully reduced, and incremental costs per quality-adjusted life year (QALY) gained
In family caregivers
- Person’s ‘sense of competence’ which is an important factor in their wellbeing (SCQ)-short form
- Distress scale of the NPI
- Physical Health (SF-36)
Background summary
This study will investigate the effects of a personal music listening intervention on neuropsychiatric symptoms in home living people with dementia. The negative impact of dementia has been widely studied: psychological, behavioural and physical symptoms decrease the quality of life of both people with dementia and their caregivers. There is thus far no cure for dementia. Since most people of dementia live at home with the help of a caregiver for as long as possible, community based interventions are highly needed. Multiple studies have found that music interventions for people with dementia may reduce or delay depression, functional problems and problem behaviour in people with dementia and distress in their caregivers. Listening to personal music by people with dementia constitutes a promising non pharmacological intervention for both people with dementia and their caregivers. However, previous studies contained a number of methodological limitations. Moreover, evidence regarding the effectiveness and cost-effectiveness of such interventions is limited.
The aim of the current study is to assess the efficacy and cost-effectiveness of a personal music listening intervention for people with dementia living at home, using a randomized controlled trial (RCT) design with a large sample size. The primary objective is to evaluate whether the personal music listening intervention improves neuropsychiatric symptoms of home living people with dementia compared to standard usual care.
Study objective
We hypothesize an improvement of neuropsychiatric symptoms in people with dementia randomized to the intervention group compared to the control group. Furthermore, the intervention is expected to enhance mood, quality of life, daily physical and functional functioning, the use of drugs and the use of respite care or admission to a nursing home
Study design
T0 – Baseline
T1 – Intermediate measurement – after 6 weeks
T2 – Post measurement – after 12 weeks, directly after intervention
T3 – First follow-up measurement – after 18 weeks, 6 weeks after intervention
T4 – Second follow-up measurement – 1 year after inclusion
Intervention
Personalized music listening
Inclusion criteria
- 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
Exclusion criteria
- 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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9412 |
| CCMO | NL73781.078.20 |
| OMON | NL-OMON55335 |