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

Not Applicable

Completed

• Conditions: Dementia, Vascular; Depression; Dementia; Behavioural and Psychiatric Symptoms of Dementia; Dementia, Mixed; Quality of Life; Dementia With Lewy Bodies; Dementia Alzheimers
• Interventions: Other: Music Intervention; Other: Reading Intervention

• Registration Number: NCT03907748
• Lead Sponsor: Anglia Ruskin University

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.

Study Timeline

• Study First Submitted: 2019-04-03
• Study First Submitted QC: 2019-04-05
• Study First Posted: 2019-04-09
• Study Start: 2019-11-20
• Status Verified: 2022-02
• Primary Completion: 2022-12-23
• Study Completion: 2022-12-23
• Last Update Submitted: 2023-02-08
• Last Update Posted: 2023-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 864

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Music Intervention	Music Intervention	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.
Reading Intervention	Reading Intervention	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline of behavioural and psychological symptoms 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)	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.

Secondary Outcome Measures

Name	Time	Method
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)	Measured by the Assessment of Quality of Life-6D (AQOL-6D).
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)	Measured by the Patient Health Questionnaire-9 (PHQ-9). Scale scores range from 0-27, where scores greater than 20 indicate severe depression.
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)	Measured by the Montgomery Asberg Depression Rating Scale (MADRS). Scale scores range from 0-60, where higher scores indicate more severe depression.
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)	Measured by the Resilience Scale-14 (RS-14). Scale scores range from 14-98, where higher scores indicate higher resilience.
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)	Measured by the EuroQoL Instrument (EQ-5D-5L).
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)	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.
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)	Measured by the Short Sense of Competence Questionnaire (SSCQ). Scale scores range from 7-35, where higher scores indicate higher sense of competence.
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)	Measured by the Quality of Caregiver-Patient Relationship (QCPR). Scale scores range from 14-70, where higher scores indicate a higher quality of relationship.
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)	Measured by the Resource Utilization in Dementia (RUD).

Trial Locations

Locations (5)

Anglia Ruskin University; 🇬🇧 Cambridge, Cambridgeshire, United Kingdom

The University of Melbourne; 🇦🇺 Melbourne, Australia

University of Applied Sciences Würzburg-Schweinfurt; 🇩🇪 Würzburg, Germany

University of Physical Education in Krakow; 🇵🇱 Kraków, Poland

Norwegian Academy of Music; 🇳🇴 Oslo, Norway