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

Anglia Ruskin University

Status: Completed

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

Treatments: Other: Music Intervention; Other: Reading Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03907748

462 (Other Grant/Funding Number)

U4-10366

ACTRN12618001799246p (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 864 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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864 participants in 3 patient groups

Music Intervention

Experimental group

Description:

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.

Treatment:

Other: Music Intervention

Reading Intervention

Active Comparator group

Description:

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.

Treatment:

Other: Reading Intervention

Standard Care

No Intervention group

Description:

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.