HOMESIDE: Home-based Family Caregiver-delivered Music and Reading Interventions for People Living With Dementia: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 864
- 试验地点
- 9
- 主要终点
- Change from baseline of behavioural and psychological symptoms of participants with dementia at post-intervention and 6-month follow-up
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome measures will be collected by researchers who are not aware of the whether the participants' are allocated to the music, reading or standard care groups. The participants will be reminded not to reveal the group they are in to the person collecting the data. The participants themselves cannot be blinded due to the active nature of the intervention.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Change from baseline of behavioural and psychological symptoms of participants with dementia at post-intervention and 6-month follow-up
时间窗: baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (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.
次要结局
- Change from baseline in quality of life of caregiver participants at post-intervention and 6-month follow-up(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(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(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(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(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(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(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(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(baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up))