Home-based Family Caregiver-delivered Music and Reading Interventions for People With Dementia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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HOMESIDE: Home-based Family Caregiver-delivered Music and Reading Interventions for People Living With Dementia: A Randomised Controlled Trial

Conditions
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Dementia, Dementia, Vascular, Dementia With Lewy Bodies, Dementia, Mixed, Dementia Alzheimers, Behavioural and Psychiatric Symptoms of Dementia, Depression, Quality of Life

Intervention / Treatment
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* Other: Music Intervention
* Other: Reading Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Dyads (cohabiting) who are close in relationship and where one member has a diagnosis of dementia according to ICD-10 criteria (Alzheimer's Disease [AD], Frontotemporal Dementia, Vascular Dementia [VD], Lewy Body Disease, or mixed dementia) as determined by a clinician experienced in diagnosing dementia. Close in relationship refers to a caregiver who may be a sibling, spouse, adult child, friend, niece or nephew or any person who has a close relationship to the person with dementia, that is, anyone who is not a formal paid caregiver. Dyads where the person with dementia has a Neuropsychiatric Inventory-Questionnaire (NPI-Q) Score of ≥6 (from a maximum score of 36) Exclusion Criteria: Dyads where either or both the caregiver or person with dementia have significant hearing impairments that are not resolved through the use of a hearing aid device and limit their capacity to enjoy musical experiences There will be no further exclusions

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants (people with dementia and their cohabiting family caregivers) will be allocated to either (1) the music intervention group, (2) the reading intervention group or (3) the standard care group.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music Intervention<br>The music intervention will be provided to participant dyads (people with dementia and their cohabiting family caregivers) allocated to the first intervention. Caregivers will be trained to use the music intervention in three 2-hour training sessions with an intervention trainer (a music therapist). Training will take place at the dyad's home. The caregiver will then be asked to deliver the music intervention to the person with dementia at least 5x per week for 30 minutes. | Other: Music Intervention<br>* 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).<br>|
| Active Comparator: Reading Intervention<br>The reading intervention will be provided to participant dyads (people with dementia and their cohabiting caregivers) allocated to the second intervention. Caregivers will be trained to use the reading intervention in three 2-hour training sessions with an intervention trainer. Training will take place at the dyad's home. The caregiver will then be asked to deliver the reading intervention to the person with dementia at least 5x per week for 30 minutes. | Other: Reading Intervention<br>* 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.<br>|
| No Intervention: Standard Care<br>Participant dyads (people with dementia and their cohabiting caregivers) allocated to the standard care group will not receive any training or be asked to deliver an intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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). | 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. | 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). | 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). | baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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music therapy, music interventions, home-based interventions, Reading, dementia, care giver