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

Depression Clinical Trial

— HOMESIDE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03907748
• Other study ID #: U4-10366
• Secondary ID: ACTRN12618001799
• Status: Completed
• Phase: N/A
• Start date: November 20, 2019
• Est. completion date: December 23, 2022

Study information

• Verified date: February 2022
• Source: Anglia Ruskin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 864
• Est. completion date: December 23, 2022
• Est. primary completion date: December 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Behavioural and Psychiatric Symptoms of Dementia
• Dementia
• Dementia Alzheimers
• Dementia With Lewy Bodies
• Dementia, Mixed
• Dementia, Vascular
• Depression
• Lewy Body Disease
• Quality of Life

Intervention

Other:
• Music Intervention
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).
• Reading Intervention
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.

Locations

Country	Name	City	State
Australia	The University of Melbourne	Melbourne
Germany	University of Applied Sciences Würzburg-Schweinfurt	Würzburg
Norway	Norwegian Academy of Music	Oslo
Poland	University of Physical Education in Krakow	Kraków
United Kingdom	Anglia Ruskin University	Cambridge	Cambridgeshire

Sponsors (9)

Lead Sponsor	Collaborator
Anglia Ruskin University	Alzheimer's Society, Cambridgeshire and Peterborough NHS Foundation Trust, Methodist Homes for the Aged, Norwegian Academy of Music, Saffron Hall Trust, University of Applied Sciences Würzburg-Schweinfurt, University of Melbourne, University School of Physical Education, Krakow, Poland

Countries where clinical trial is conducted

Australia,  Germany,  Norway,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intervention dosage throughout intervention	Measured using the tailored diary for caregivers to record the duration of music or reading intervention use, responses of the person with dementia and details of activities used.	Throughout the 12-weeks caregiver-delivered intervention (at least 5x per week)
Other	Caregivers' experiences of delivering the music and reading interventions	Measured using post-intervention qualitative interviews with caregivers to capture descriptions of their experience of delivering the intervention and data to fine-tune the training, research design and the protocol.	12-weeks (primary time point)
Other	Caregivers' experiences and reactions to the music and reading intervention training sessions	Measured using a short questionnaire.	Post intervention training sessions at 1-week, 3-weeks, and 6-weeks
Other	Caregivers' adherence to programme and ability to apply the learning from the training sessions in their day-to-day caring	Measured using the tailored diary for caregivers to record the duration of music or reading intervention use, responses of the person with dementia and details of activities used	Throughout the 12-weeks caregiver-delivered intervention (at least 5x per week)
Other	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	Measured using the Mini-Mental State Examination (MMSE). Scores Higher scores indicate better cognitive capacity with scores of 24-30 indicating no cognitive impairment; 19-23 indicating mild cognitive impairment; 10-18 indicating moderate cognitive impairment; and scores <10 indicating severe cognitive impairment.	baseline and 12-weeks (primary time-point, post-intervention)
Other	Adverse events	Adverse events will be measured throughout the 12-week intervention period for all groups via fortnightly phone calls. Participants will be asked about any adverse events they may have experienced, including hospitalisations, unexpected GP appointments or negative responses to the interventions.	Phone calls at weeks 2, 4, 6, 8, 10, 12
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)