This international study evaluates the impact of home-based caregiver-delivered music and reading interventions for people with dementia. The project aims to address the need for improved informal dementia care by training family caregivers to utilise a music or reading intervention with the person they are caring for. The interventions aim to decrease behavioural and psychological symptoms of dementia as well as improve quality of life and well being of both people living with dementia and their caregivers. Participants will be allocated into a music intervention group, a reading intervention group or standard care group. In addition, the researchers will seek to determine the cost-effectiveness of using the music intervention.
This three-arm parallel-group randomised controlled trial will involve 495 couples (cohabiting caregivers and people with dementia) across 5 countries. Caregivers allocated to the music or reading intervention groups will be given three 2-hour training sessions in the allocated intervention. They will be asked to deliver the intervention to the person they are caring for 5x weekly for 3 months. Data will be collected prior to implementing the intervention, during the intervention (via diaries kept by the caregivers), after the last week of implementing the intervention and 3-months after implementing the intervention. The investigators will explore whether caregiver-delivered music or reading activities improve behavioural and psychological symptoms for people living with dementia. The researchers will also seek to find out the impact on other aspects of both the person with dementia and their caregiver's quality of life and well being. Additionally, costs associated with the care of the person with dementia will be evaluated to determine cost-effectiveness of delivering a music intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
864
After training, caregivers will deliver the music intervention to the person with dementia whom they care for. The music intervention will include: a) singing familiar/preferred music followed by discussions facilitated by the caregiver about any associated meanings or memories; b) movement to music (e.g. upper body and arms imitating familiar dance movements to music); c) instrument playing; and d) listening to familiar/preferred relaxing or enlivening music (dependent upon symptoms present in the moment). These methods are known to assist in emotion regulation and increase cognitive reserve (e.g. attention and perceptual-motor function).
After training, caregivers will deliver the reading intervention to the person with dementia whom they care for. The reading intervention will include: a) the caregiver reading aloud to the person they are caring for; b) the person with dementia reading aloud to their caregiver; and c) discussion of the text and personal responses. Strategies to engage the person with dementia and to create opportunities for meaningful dialogue will be provided, as well as guidance on selecting reading material that is accessible to the person's level of cognitive impairment.
The University of Melbourne
Melbourne, Australia
University of Applied Sciences Würzburg-Schweinfurt
Würzburg, Germany
Norwegian Academy of Music
Oslo, Norway
University of Physical Education in Krakow
Krakow, Poland
Anglia Ruskin University
Cambridge, Cambridgeshire, United Kingdom
Change from baseline of behavioural and psychological symptoms of participants with dementia at post-intervention and 6-month follow-up
Measured by the Neuropsychiatric Inventory Questionnaire (NPI-Q). Severity scores range from 0-36, where higher scores indicate more severe behavioural and psychological symptoms of dementia. Distress scores range from 0-60, where higher values represent higher levels of distress due to symptoms.
Time frame: baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)
Change from baseline of depression in participants with dementia at post-intervention and 6-month follow-up
Measured by the Montgomery Asberg Depression Rating Scale (MADRS). Scale scores range from 0-60, where higher scores indicate more severe depression.
Time frame: baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)
Change from baseline of quality of life of participants with dementia at post-intervention and 6-month follow-up
Measured by the Quality of Life - Alzheimer's Disease (QoL-AD) scale. Scale scores range from 13-52, where higher scores indicate higher quality of life.
Time frame: baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)
Change from baseline of depression in caregiver participants at post-intervention and 6-month follow-up
Measured by the Patient Health Questionnaire-9 (PHQ-9). Scale scores range from 0-27, where scores greater than 20 indicate severe depression.
Time frame: baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)
Change from baseline of resilience in caregiver participants at post-intervention and 6-month follow-up
Measured by the Resilience Scale-14 (RS-14). Scale scores range from 14-98, where higher scores indicate higher resilience.
Time frame: baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)
Change from baseline in caregiver competence of caregiver participants at post-intervention and 6-month follow-up
Measured by the Short Sense of Competence Questionnaire (SSCQ). Scale scores range from 7-35, where higher scores indicate higher sense of competence.
Time frame: baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)
Change from baseline in quality of life of caregiver participants at post-intervention and 6-month follow-up
Measured by the Assessment of Quality of Life-6D (AQOL-6D).
Time frame: baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)
Change from baseline in quality of the relationship between caregiver and person with dementia at post-intervention and 6-month follow-up
Measured by the Quality of Caregiver-Patient Relationship (QCPR). Scale scores range from 14-70, where higher scores indicate a higher quality of relationship.
Time frame: baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)
Change from baseline in quality of adjusted life-years of caregiver and person with dementia at post-intervention and 6-month follow-up
Measured by the EuroQoL Instrument (EQ-5D-5L).
Time frame: baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)
Change from baseline in resource use of both caregiver and person with dementia (cost-effectiveness) at post-intervention and 6-month follow-up
Measured by the Resource Utilization in Dementia (RUD).
Time frame: baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)
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