Clinical trial NCT05176444: Managing the Needs of Care Home Residents With Dementia Through a Music Therapy Intervention
Official title: Managing the Needs of Care Home Residents Through a Music Therapy Intervention: A Non-randomised Feasibility Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cognitive Impairment
Dementia
Keywords: Dementia
Music therapy
Cognition
Care home
Quality of care
Non-pharmacological intervention
Needs
Neuropsychiatric symptoms
Lead sponsor: Anglia Ruskin University
Sponsor class: OTHER
Collaborators: name: Anchor Trust
name: The Utley Foundation
First posted: 2022-01-04
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to implement and evaluate a music therapy intervention in care homes. The primary aim is to assess whether implementing the intervention will have an impact on unmet in care homes for people living with dementia. Researchers will also examine the feasibility of a music therapy programme in care homes and its effects on care staff and residents with cognitive impairment. Care home staff will also receive training with music therapists via video communications to help staff use music therapy techniques to support people living with dementia.

Detailed description: This project aims to evaluate the feasibility and effectiveness of a 12-week music therapy programme in care homes for residents with cognitive impairment/dementia and care home staff using a non-randomised control design. Music therapy is widely recognised as beneficial for people living with dementia. However, little is known about its overall impact on quality of care in care homes.

Research questions:

1. Can a music therapy intervention improve quality of care in care homes by supporting residents' needs?
2. What are the effects of music therapy on residents with cognitive impairment and care home staff?
3. Is the implementation of a music therapy programme feasible in care homes?
4. For the treatment of symptoms of dementia, is music therapy a cost-effective treatment in care homes?

Intervention:

The team will invite a total of 84 participants from 12 care homes located across the North and South of England to take part in the study. This includes 48 participants with cognitive impairment/dementia and 36 care home staff. The team will recruit a qualified music therapist in each region to work within the care home to deliver the music therapy intervention.

Residents with cognitive impairment/dementia will be invited to receive twenty 30-minute individual music therapy sessions across 12 weeks. The therapy will be video recorded for training purposes. Data will be collected about residents to learn about their needs and any health and wellbeing symptoms. This will help inform music therapists about each individuals' specific needs so that they can tailor a suitable treatment approach. They will enable a meaningful, engaging therapeutic relationship to improve the health and wellbeing of residents. The sessions will focus on targeting specific behavioural and psychological symptoms of dementia by providing cognitive stimulation, communicative support and social connectedness.

Within the 12-week programme, care home staff participants will be invited to collectively receive music therapy training on four occasions during week 3, 6, 9 and 12. Each music therapist will demonstrate significant moments of their sessions to staff via short video clips from a music therapy session. They will provide clinical explanations to staff about the techniques they have used and why they are effective for the individuals with cognitive impairment.

Data collection:

The team will be collecting a range of qualitative and quantitative data. The researchers will use an integrated evaluative approach focussing on clinical and organisational outcomes to examine the research questions. As part of the non-randomised control design, six of the care homes will be in the intervention group and receive the music therapy programme. There will be 42 participants in this group (24 with cognitive impairment, 18 care home staff). The remaining six care homes will form the control group and receive treatment as usual. Baseline and post 12-week data will be collected from all homes to compare differences between groups. Within group data will also be compared from the intervention homes.

Once all of the data has been collected from the control group care homes, they will then go on to receive the music therapy programme with the same amount and ratio of participants.

Implications:

The study has the potential to improve the lives of care home residents living with cognitive impairment/dementia. It also has the potential to improve the work life of care home staff and generate better quality of care. Staff will be provided with the tools and understanding of music therapy techniques, so that the potential effects can be sustainable. Standardised protocols are needed to learn about how researchers and practitioners can work with the social care sector to implement an effective music therapy programme. The evaluation of this study will inform this sector about the feasibility and effectiveness of music therapy care in care homes. The study findings will provide valuable insights into how to transform the social care sector through psychosocial, non-pharmacological intervention at micro and macro level.

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Eligibility criteria: Inclusion criteria

The proposed inclusion criteria for care home residents are as follows:

* Participants must be aged 50+ years
* Participants will be a resident of one of the 12 care homes taking part
* For each participant, there must be clinical evidence of cognitive impairment. This will be determined by a score of 24 or under on the SMMSE
* Each participant must display at least one behavioural/psychological symptom of dementia. This will be determined by a score of 4 or higher on the NPI-NH.

The proposed inclusion criteria for care home staff are as follows:

* Participants must be aged 18+ years
* Participants must have worked in the care home for at least 3 months
* Participants will be required to have in-depth knowledge of the resident participant(s). This will be determined through communications with home managers to ensure each staff member is paired with a resident they provide regular care for.

Exclusion Criteria

Exclusion criteria for care home residents:

- Participants who's health appears to be at risk which raises the concerns of their sustained involvement with the study. This would be evident from a health assessment from a general practitioner. Given that this is a music therapy study, this could also include people with a hearing impairment.

Exclusion criteria for care home staff:

- Staff who cannot adequately answer on behalf of the residents due to lack of knowledge of the residents.

Primary outcomes:
measure: Camberwell Assessment of Needs in the Elderly - CANE
timeFrame: 15 minutes
Secondary outcomes:
measure: Standardised Mini Mental State Examination - SMMSE
timeFrame: 15 minutes
measure: Neuropsychiatric Inventory Nursing Homes - NPI-NH
timeFrame: 12 minutes
measure: EuroQoL - EQ-5D-5L - self completion
timeFrame: 5 minutes
measure: EuroQoL - EQ-5D-5L - proxy
timeFrame: 5 minutes
measure: Barthel Index (BI)
timeFrame: 10 minutes
measure: Job Satisfaction Index (JSI)
timeFrame: 10 minutes
measure: Maslach Burnout Inventory - Human services (MBI-HSS)
timeFrame: 10 minutes
measure: Qualitative semi-structured Interviews
timeFrame: 10 - 20 minutes
measure: Client Service Receipt Inventory (CSRI Dementia)
timeFrame: 15 minutes
measure: Total number of staff at the care home
timeFrame: 2 minutes
Other outcomes:
Locations:
city: Banstead
country: United Kingdom
facility: Ridgemount
state: Surrey
city: London
country: United Kingdom
facility: Oakleigh, Godstone
state: Surrey
city: London
country: United Kingdom
facility: Greenacres, Banstead
state: Surrey
city: Doncaster
country: United Kingdom
facility: Hatfield House
city: Leeds
country: United Kingdom
facility: Simon Marks Court
city: Leeds
country: United Kingdom
facility: Oak Tree Lodge
city: Newquay
country: United Kingdom
facility: Kimberly Court
city: Otley
country: United Kingdom
facility: Wharfside
city: Saltash
country: United Kingdom
facility: St Anne's
city: Sheffield
country: United Kingdom
facility: Prior Bank
city: Sheffield
country: United Kingdom
facility: Herries Lodge
Study officials:
affiliation: Anglia Ruskin University
name: Helen Odell-Miller, PhD
role: STUDY_DIRECTOR
References: