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

Primary Purpose

Dementia, Dementia, Vascular, Dementia With Lewy Bodies

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Music Intervention
Reading Intervention
Sponsored by
Anglia Ruskin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dementia focused on measuring music therapy, music interventions, home-based interventions, Reading, dementia, care giver

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The University of Melbourne
  • University of Applied Sciences Würzburg-Schweinfurt
  • Norwegian Academy of Music
  • University of Physical Education in Krakow
  • Anglia Ruskin University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Music Intervention

Reading Intervention

Standard Care

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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).
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.
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).
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).

Full Information

First Posted
April 3, 2019
Last Updated
February 8, 2023
Sponsor
Anglia Ruskin University
Collaborators
University of Melbourne, Norwegian Academy of Music, University of Applied Sciences Würzburg-Schweinfurt, University School of Physical Education, Krakow, Poland, Alzheimer's Society, Methodist Homes for the Aged, Saffron Hall Trust, Cambridgeshire and Peterborough NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03907748
Brief Title
Home-based Family Caregiver-delivered Music and Reading Interventions for People With Dementia
Acronym
HOMESIDE
Official Title
HOMESIDE: Home-based Family Caregiver-delivered Music and Reading Interventions for People Living With Dementia: A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
November 20, 2019 (Actual)
Primary Completion Date
December 23, 2022 (Actual)
Study Completion Date
December 23, 2022 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
864 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Music Intervention
Arm Type
Experimental
Arm 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.
Arm Title
Reading Intervention
Arm Type
Active Comparator
Arm 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.
Arm Title
Standard Care
Arm Type
No Intervention
Arm 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.
Intervention Type
Other
Intervention Name(s)
Music Intervention
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Reading Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline of behavioural and psychological symptoms of participants with dementia at post-intervention and 6-month follow-up
Description
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.
Time Frame
baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)
Secondary Outcome Measure Information:
Title
Change from baseline of depression in participants with dementia at post-intervention and 6-month follow-up
Description
Measured by the Montgomery Asberg Depression Rating Scale (MADRS). Scale scores range from 0-60, where higher scores indicate more severe depression.
Time Frame
baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)
Title
Change from baseline of quality of life of participants with dementia at post-intervention and 6-month follow-up
Description
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.
Time Frame
baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)
Title
Change from baseline of depression in caregiver participants at post-intervention and 6-month follow-up
Description
Measured by the Patient Health Questionnaire-9 (PHQ-9). Scale scores range from 0-27, where scores greater than 20 indicate severe depression.
Time Frame
baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)
Title
Change from baseline of resilience in caregiver participants at post-intervention and 6-month follow-up
Description
Measured by the Resilience Scale-14 (RS-14). Scale scores range from 14-98, where higher scores indicate higher resilience.
Time Frame
baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)
Title
Change from baseline in caregiver competence of caregiver participants at post-intervention and 6-month follow-up
Description
Measured by the Short Sense of Competence Questionnaire (SSCQ). Scale scores range from 7-35, where higher scores indicate higher sense of competence.
Time Frame
baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)
Title
Change from baseline in quality of life of caregiver participants at post-intervention and 6-month follow-up
Description
Measured by the Assessment of Quality of Life-6D (AQOL-6D).
Time Frame
baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)
Title
Change from baseline in quality of the relationship between caregiver and person with dementia at post-intervention and 6-month follow-up
Description
Measured by the Quality of Caregiver-Patient Relationship (QCPR). Scale scores range from 14-70, where higher scores indicate a higher quality of relationship.
Time Frame
baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)
Title
Change from baseline in quality of adjusted life-years of caregiver and person with dementia at post-intervention and 6-month follow-up
Description
Measured by the EuroQoL Instrument (EQ-5D-5L).
Time Frame
baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)
Title
Change from baseline in resource use of both caregiver and person with dementia (cost-effectiveness) at post-intervention and 6-month follow-up
Description
Measured by the Resource Utilization in Dementia (RUD).
Time Frame
baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up)
Other Pre-specified Outcome Measures:
Title
Intervention dosage throughout intervention
Description
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.
Time Frame
Throughout the 12-weeks caregiver-delivered intervention (at least 5x per week)
Title
Caregivers' experiences of delivering the music and reading interventions
Description
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.
Time Frame
12-weeks (primary time point)
Title
Caregivers' experiences and reactions to the music and reading intervention training sessions
Description
Measured using a short questionnaire.
Time Frame
Post intervention training sessions at 1-week, 3-weeks, and 6-weeks
Title
Caregivers' adherence to programme and ability to apply the learning from the training sessions in their day-to-day caring
Description
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
Time Frame
Throughout the 12-weeks caregiver-delivered intervention (at least 5x per week)
Title
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
Description
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.
Time Frame
baseline and 12-weeks (primary time-point, post-intervention)
Title
Adverse events
Description
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.
Time Frame
Phone calls at weeks 2, 4, 6, 8, 10, 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felicity Baker, Professor
Organizational Affiliation
University of Melbourne
Official's Role
Study Director
Facility Information:
Facility Name
The University of Melbourne
City
Melbourne
ZIP/Postal Code
3006
Country
Australia
Facility Name
University of Applied Sciences Würzburg-Schweinfurt
City
Würzburg
ZIP/Postal Code
97070
Country
Germany
Facility Name
Norwegian Academy of Music
City
Oslo
ZIP/Postal Code
0302
Country
Norway
Facility Name
University of Physical Education in Krakow
City
Kraków
Country
Poland
Facility Name
Anglia Ruskin University
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB1 1PT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
In accordance with the Australian Code for Responsible Conduct of Research (Universities Australia, 2018), all data will be retained for retrieval and re-use in future research where participant permission is granted. Data made available will include individual-level deidentified participant data, reports on adverse events, and deidentified interview transcripts.
IPD Sharing Time Frame
Following project completion, de-identified anonymised data will be made available (with participant consent). According to the GDPR, the consortium have agreed for reused for 10 years after the project has been completed.
IPD Sharing Access Criteria
Data will be made available on the Australian Data Archive https://ada.edu.au and listed on Research Australia's https://researchaustralia.org website to facilitate access for future research.
Citations:
PubMed Identifier
31748300
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.
Results Reference
derived

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

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