Clinical trial NCT03907748: Home-based Family Caregiver-delivered Music and Reading Interventions for People With Dementia
Official title: HOMESIDE: Home-based Family Caregiver-delivered Music and Reading Interventions for People Living With Dementia: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Dementia, Vascular
Dementia With Lewy Bodies
Dementia, Mixed
Dementia Alzheimers
Behavioural and Psychiatric Symptoms of Dementia
Depression
Quality of Life
Keywords: music therapy
music interventions
home-based interventions
Reading
dementia
care giver
Lead sponsor: Anglia Ruskin University
Sponsor class: OTHER
Collaborators: name: University of Melbourne
name: Norwegian Academy of Music
name: University of Applied Sciences Würzburg-Schweinfurt
name: University School of Physical Education, Krakow, Poland
name: Alzheimer's Society
name: Methodist Homes for the Aged
name: Saffron Hall Trust
name: Cambridgeshire and Peterborough NHS Foundation Trust
First posted: 2019-04-09
Enrollment: 864
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline of behavioural and psychological symptoms of participants with dementia at post-intervention and 6-month follow-up
timeFrame: baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)
Secondary outcomes:
measure: Change from baseline of depression in participants with dementia at post-intervention and 6-month follow-up
timeFrame: baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)
measure: Change from baseline of quality of life of participants with dementia at post-intervention and 6-month follow-up
timeFrame: baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)
measure: Change from baseline of depression in caregiver participants at post-intervention and 6-month follow-up
timeFrame: baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)
measure: Change from baseline of resilience in caregiver participants at post-intervention and 6-month follow-up
timeFrame: baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)
measure: Change from baseline in caregiver competence of caregiver participants at post-intervention and 6-month follow-up
timeFrame: baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)
measure: Change from baseline in quality of life of caregiver participants at post-intervention and 6-month follow-up
timeFrame: baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)
measure: Change from baseline in quality of the relationship between caregiver and person with dementia at post-intervention and 6-month follow-up
timeFrame: baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)
measure: Change from baseline in quality of adjusted life-years of caregiver and person with dementia at post-intervention and 6-month follow-up
timeFrame: baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)
measure: Change from baseline in resource use of both caregiver and person with dementia (cost-effectiveness) at post-intervention and 6-month follow-up
timeFrame: baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)
Other outcomes:
measure: Intervention dosage throughout intervention
timeFrame: Throughout the 12-weeks caregiver-delivered intervention (at least 5x per week)
measure: Caregivers' experiences of delivering the music and reading interventions
timeFrame: 12-weeks (primary time point)
measure: Caregivers' experiences and reactions to the music and reading intervention training sessions
timeFrame: Post intervention training sessions at 1-week, 3-weeks, and 6-weeks
measure: Caregivers' adherence to programme and ability to apply the learning from the training sessions in their day-to-day caring
timeFrame: Throughout the 12-weeks caregiver-delivered intervention (at least 5x per week)
measure: Change from baseline of cognition of participants with dementia at post-intervention to explore relationship between cognitive decline, behavioural and psychological symptoms of dementia, depression and response to different conditions
timeFrame: baseline and 12-weeks (primary time-point, post-intervention)
measure: Adverse events
timeFrame: Phone calls at weeks 2, 4, 6, 8, 10, 12
Locations:
city: Melbourne
country: Australia
facility: The University of Melbourne
city: Würzburg
country: Germany
facility: University of Applied Sciences Würzburg-Schweinfurt
city: Oslo
country: Norway
facility: Norwegian Academy of Music
city: Kraków
country: Poland
facility: University of Physical Education in Krakow
city: Cambridge
country: United Kingdom
facility: Anglia Ruskin University
state: Cambridgeshire
Study officials:
affiliation: University of Melbourne
name: Felicity Baker, Professor
role: STUDY_DIRECTOR
References:
citation: Baker FA, Bloska J, Braat S, Bukowska A, Clark I, Hsu MH, Kvamme T, Lautenschlager N, Lee YC, Smrokowska-Reichmann A, Sousa TV, Stensaeth KA, Tamplin J, Wosch T, Odell-Miller H. HOMESIDE: home-based family caregiver-delivered music and reading interventions for people living with dementia: protocol of a randomised controlled trial. BMJ Open. 2019 Nov 19;9(11):e031332. doi: 10.1136/bmjopen-2019-031332.