The main objective of this study is to investigate the effects of listening to individualized music two times a day for minimal 20 minutes during 12 weeks on neuropsychiatric symptoms in people with dementia living at home and on distress and…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Dementie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The endpoint of the study is the difference from baseline to post-intervention
in reported scores of problem behaviour (NPI) in people with dementia.
Secondary outcome
Secondary endpoints for people with dementia are positive affect (PANAS), in
self-reported mood-score defined with the Geriatric Depression Scale (GDS),
quality of life (QoL-AD), 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), and the use of respite care or admission to a
nursing home. Furthermore, we will study the effects on physical health (SF-36)
and distress in family caregivers (Sense of Competence Questionnaire and
distress scale of the NPI) and cost-effectiveness.
Background summary
This study will investigate the effects of listening to a recorded personal
music intervention twice a day in people with dementia and their caregivers.
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 and distress in
their caregivers. Listening to individualized music constitutes a promising
non/pharmacological intervention for 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.
Study objective
The main objective of this study is to investigate the effects of listening to
individualized music two times a day for minimal 20 minutes during 12 weeks on
neuropsychiatric symptoms in people with dementia living at home and on
distress and physical health of caregivers. Secondary objectives are to study
the effects of listening to individualized music on 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. Furthermore, we will study the
effects on distress and physical health in the caregiver and the
cost-effectiveness of the music intervention.
Study design
This study will be performed as a randomised controlled intervention trial.
Intervention
People with dementia randomised to the intervention group will receive a
receptive individualized music intervention two times a day for minimal 20
minutes during 12 weeks, The control group will receive standard care alone.
Study burden and risks
The use of music as intervention has no known deleterious effects on people
with dementia. Safety precautions will be taken to limit the volume of the
music. Participants in all study arms will receive standard usual care. Burden
includes the completion of only two scales: self-reported mood/affect-scores
defined with the Geriatric Depression Scale (GDS) and the PANAS. Other
measurements are proxy scores completed by the caregiver with assistance of the
research assistant during a phone call. A part of the baseline measurements
will be collected from normal care data gathered from regular participants*
geriatrician visits in Erasmus MC University (Table 1). No extra site visits
will be necessary for participation in this study besides the regular check-ups
with their own geriatrician and/or usual care.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
* - Adult people diagnosed with dementia (mild to moderate: Global
Deterioration Scale score for
assessment of primary degenerative dementia `<=5) by a phy-sician
* - 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
representives
Exclusion criteria
* - Hearing impairments
* - Presence of delirium
* - Starting using new psychotropic drugs <6 weeks before inclusion
* - Life expectancy < 6 months
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL73781.078.20 |
OMON | NL-OMON27014 |