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Trial record 52 of 83 for:    lewy body dementia

A Home-based Family Caregiver-delivered Music Intervention for People With Dementia (HOMESIDE)

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ClinicalTrials.gov Identifier: NCT03907748
Recruitment Status : Not yet recruiting
First Posted : April 9, 2019
Last Update Posted : April 17, 2019
Sponsor:
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
Cambridge and Peterborough NHS Foundation Trust
Information provided by (Responsible Party):
Anglia Ruskin University

Brief Summary:
This international study evaluates the impact of a home-based caregiver-delivered music intervention for people with dementia. The project aims to address the need for improved informal dementia care by training family caregivers to utilise a music intervention with the person they are caring for. The music intervention aims 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.

Condition or disease Intervention/treatment Phase
Dementia Dementia, Vascular Dementia With Lewy Bodies Dementia, Mixed Dementia Alzheimers Behavioural and Psychiatric Symptoms of Dementia Depression Quality of Life Other: Music Intervention Other: Reading Intervention Not Applicable

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 believe that there will be a significant improvement in behavioural and psychological symptoms for those participants with dementia who receive the music intervention delivered by their caregiver, as compared with the reading intervention or standard care. 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 990 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Double (Investigator, 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.
Primary Purpose: Supportive Care
Official Title: HOMESIDE: A Home-based Family Caregiver-delivered Music Intervention for People Living With Dementia: A Randomised Controlled Trial
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : June 1, 2022


Arm Intervention/treatment
Experimental: 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.
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).

Active Comparator: 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.
Other: 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.

No Intervention: Standard Care
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.



Primary Outcome Measures :
  1. Change from baseline of behavioural and psychological symptoms of participants with dementia at post-intervention and 6-month follow-up [ Time Frame: 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 :
  1. Change from baseline of depression in participants with dementia at post-intervention and 6-month follow-up [ Time Frame: 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.

  2. Change from baseline of quality of life of participants with dementia at post-intervention and 6-month follow-up [ Time Frame: 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.

  3. Change from baseline of depression in caregiver participants at post-intervention and 6-month follow-up [ Time Frame: 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.

  4. Change from baseline of resilience in caregiver participants at post-intervention and 6-month follow-up [ Time Frame: 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.

  5. Change from baseline in caregiver competence of caregiver participants at post-intervention and 6-month follow-up [ Time Frame: 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.

  6. Change from baseline in quality of life of caregiver participants at post-intervention and 6-month follow-up [ Time Frame: 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).

  7. Change from baseline in quality of the relationship between caregiver and person with dementia at post-intervention and 6-month follow-up [ Time Frame: 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.

  8. Change from baseline in quality of adjusted life-years of caregiver and person with dementia at post-intervention and 6-month follow-up [ Time Frame: baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up) ]
    Measured by the EuroQoL Instrument (EQ-5D-5L).

  9. Change from baseline in resource use of both caregiver and person with dementia (cost-effectiveness) at post-intervention and 6-month follow-up [ Time Frame: baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up) ]
    Measured by the Resource Utilization in Dementia (RUD).


Other Outcome Measures:
  1. Intervention dosage throughout intervention [ Time Frame: Throughout the 12-weeks caregiver-delivered intervention (at least 5x per week) ]
    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.

  2. Caregivers' experiences of delivering the music and reading interventions [ Time Frame: 12-weeks (primary time point) ]
    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.

  3. Caregivers' experiences and reactions to the music and reading intervention training sessions [ Time Frame: Post intervention training sessions at 1-week, 3-weeks, and 6-weeks ]
    Measured using a short questionnaire.

  4. Caregivers' learning and new skills in managing dementia symptoms and implementing the music or reading interventions developed in the training sessions [ Time Frame: baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up) ]
    Measured using the Sense of Competence in Dementia Care Staff (SCIDS) scale. Scale scores range from 17-68, where higher scores indicate higher sense of competence and confidence.

  5. Caregivers' adherence to programme and ability to apply the learning from the training sessions in their day-to-day caring [ Time Frame: Throughout the 12-weeks caregiver-delivered intervention (at least 5x per week) ]
    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

  6. 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 [ Time Frame: baseline and 12-weeks (primary time-point, post-intervention) ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Dyads (cohabiting) who are close in relationship and where one member has a diagnosis of dementia (Alzheimer's Disease [AD], Frontotemporal Dementia, Vascular Dementia [VD], Lewy Body Disease, or mixed dementia) as determined by a medical professional such as a geriatrician/neuropsychologist.
  • Dyads where the participant with dementia has a Neuropsychiatric Inventory-Questionnaire (NPI-Q) Score of >6. There will be no restrictions on including people with dementia with mild cognitive impairment, as research indicates that NPI-Q scores >6 occur in people with dementia who have high Mini Mental State Examination Scores (MMSE scores 20-24).

Exclusion Criteria:

  • Dyads where the caregiver employs paid carers for more than 5 hours per day on at least 5 days per week.
  • There will be no further exclusions.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03907748


Contacts
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Contact: Felicity Baker, Professor +61402172795 felicity.baker@unimelb.edu.au
Contact: Helen M Odell-Miller, Professor 004489451962045 helen.odell-miller@anglia.ac.uk

Locations
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Australia
The University of Melbourne Not yet recruiting
Melbourne, Australia, 3006
Contact: Felicity Baker, Professor    +61402172795    felicity.baker@unimelb.edu.au   
Germany
University of Applied Sciences Würzburg-Schweinfurt
Würzburg, Germany, 97070
Norway
Norwegian Academy of Music Not yet recruiting
Oslo, Norway, 0302
Contact: Karette Stensaeth, A/Professor    +47 94844648    Karette.A.Stensaeth@nmh.no   
Poland
University of Physical Education in Krakow
Kraków, Poland
United Kingdom
Anglia Ruskin University Not yet recruiting
Cambridge, Cambridgeshire, United Kingdom, CB1 1PT
Contact: Helen Odell-Miller, Professor    01223698045    helen.odell-miller@anglia.ac.uk   
Sponsors and Collaborators
Anglia Ruskin University
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
Cambridge and Peterborough NHS Foundation Trust
Investigators
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Study Director: Felicity Baker, Professor University of Melbourne

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Responsible Party: Anglia Ruskin University
ClinicalTrials.gov Identifier: NCT03907748     History of Changes
Other Study ID Numbers: U4-10366
ACTRN12618001799246p ( Registry Identifier: Austrailian New Zealand Clinical Trials Registry )
462 ( Other Grant/Funding Number: Alzheimer's Society )
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Anglia Ruskin University:
music therapy
music interventions
home-based interventions
Reading
dementia
care giver

Additional relevant MeSH terms:
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Dementia
Lewy Body Disease
Dementia, Vascular
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Tauopathies
Neurodegenerative Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Movement Disorders
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Leukoencephalopathies
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases