search
Back to results

Managing the Needs of Care Home Residents With Dementia Through a Music Therapy Intervention

Primary Purpose

Cognitive Impairment, Dementia

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Music therapy
Sponsored by
Anglia Ruskin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Impairment focused on measuring Dementia, Music therapy, Cognition, Care home, Quality of care, Non-pharmacological intervention, Needs, Neuropsychiatric symptoms

Eligibility Criteria

18 Years - 105 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 via a screening form for staff to complete based on how well they know the residents. This will be administered prior to the commencement of the study.

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.

Sites / Locations

  • Ridgemount
  • Oakleigh, Godstone
  • Greenacres, BansteadRecruiting
  • Hatfield HouseRecruiting
  • Simon Marks Court
  • Oak Tree Lodge
  • Kimberly Court
  • Wharfside
  • St Anne's
  • Prior Bank
  • Herries Lodge

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Music therapy intervention

Control group - standard care

Arm Description

Music therapy

Standard care for residents with cognitive impairment. Staff will not receive music therapy training.

Outcomes

Primary Outcome Measures

Camberwell Assessment of Needs in the Elderly - CANE
For people with cognitive impairment - to measure the quality of care in care homes by assessing individual needs. This measure examines met and unmet needs in older people in 24 areas from self-care to communicative abilities. 1 = a met need, 2 = an unmet need. Met needs and unmet needs are totalled. A higher score indicates a higher number of needs.

Secondary Outcome Measures

Standardised Mini Mental State Examination - SMMSE
For people with cognitive impairment - a standardised assessment to test cognitive function of residents in care homes. This version will factor in participants with various impairments such as visual and motor issues. Scores are between 0 and 30. Lower scores indicate lower cognitive function.
Neuropsychiatric Inventory Nursing Homes - NPI-NH
Care home staff will be interviewed to measure the neuropsychiatric symptoms of people with dementia in care homes. Data is collected about a range of symptoms from A-J including delusions, anxiety, aberrant motor behaviours, disinhibition. If a symptom is present, the frequency is scored from 1 (rarely) - 4 (very often), the severity is scored from 1 (mild) - 3 (severe). Frequency x severity provides an NPI score for each present symptom which is totalled. Occupational disruptiveness is also scored for a present symptom from 1 (not at all) - 5 (very severe). Occupational disruptiveness scores are totalled to provide an overall score.
EuroQoL - EQ-5D-5L - self completion
Residents will respond to which level they perceive in five domains (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) with level 1 (no problem) to level 5 (extremely). Each number representing a level will develop a code (e.g. 11111 would indicate no problems in health related quality of life). These scores can then be formulated into an index value.
EuroQoL - EQ-5D-5L - proxy
The same measure as above to assess proxy health related quality of life. This will be completed by a care staff member and scoring will be as above.
Barthel Index (BI)
A survey link will be sent out to care staff to measure the perceived functional abilities of the individuals with dementia such as feeding, bathing etc. Care staff will be asked the questions to provide their opinions on one domain (activities of daily living) with 10 items. Scores range between 0 and 100. A higher score indicates a better outcome with higher levels of independence.
Job Satisfaction Index (JSI)
A survey link will be sent out to care staff to measure job satisfaction based on 18 statements using five categories from strongly agree - strongly disagree.
Maslach Burnout Inventory - Human services (MBI-HSS)
A survey link will be sent out to care staff to measure burnout. Questions are based around three areas: emotional exhaustion, depersonalisation and personal accomplishments. There are a total of 22 questions related to how one feels in their job, on a scale from 0 (never) - 6 (every day). Average scores are calculated.
Qualitative semi-structured Interviews
A semi-structured interview with care staff will be carried out at baseline in both groups until data saturation is met. This interview consists of questions about the concept of quality of care and job satisfaction. Another interview will be carried out with all care staff participants in the intervention group at the end of the music therapy treatment to evaluate the music therapy process.
Client Service Receipt Inventory (CSRI Dementia)
A measure of the cost effectiveness of the music therapy in care homes. This instrument collects information about service usage of residents, medication usage and overall care home costs.
Total number of staff at the care home
The total number of staff at each care home is collected in both groups, pre and post to examine staff retention and turnover.

Full Information

First Posted
December 15, 2021
Last Updated
June 2, 2023
Sponsor
Anglia Ruskin University
Collaborators
Anchor Trust, The Utley Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT05176444
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 4, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anglia Ruskin University
Collaborators
Anchor Trust, The Utley Foundation

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
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: Can a music therapy intervention improve quality of care in care homes by supporting residents' needs? What are the effects of music therapy on residents with cognitive impairment and care home staff? Is the implementation of a music therapy programme feasible in care homes? 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. .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment, Dementia
Keywords
Dementia, Music therapy, Cognition, Care home, Quality of care, Non-pharmacological intervention, Needs, Neuropsychiatric symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Music therapy intervention
Arm Type
Experimental
Arm Description
Music therapy
Arm Title
Control group - standard care
Arm Type
No Intervention
Arm Description
Standard care for residents with cognitive impairment. Staff will not receive music therapy training.
Intervention Type
Behavioral
Intervention Name(s)
Music therapy
Intervention Description
Individual music therapy sessions across 12-weeks with people with cognitive impairment/dementia. Music therapy training for care home staff at four time points across 12-weeks.
Primary Outcome Measure Information:
Title
Camberwell Assessment of Needs in the Elderly - CANE
Description
For people with cognitive impairment - to measure the quality of care in care homes by assessing individual needs. This measure examines met and unmet needs in older people in 24 areas from self-care to communicative abilities. 1 = a met need, 2 = an unmet need. Met needs and unmet needs are totalled. A higher score indicates a higher number of needs.
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Standardised Mini Mental State Examination - SMMSE
Description
For people with cognitive impairment - a standardised assessment to test cognitive function of residents in care homes. This version will factor in participants with various impairments such as visual and motor issues. Scores are between 0 and 30. Lower scores indicate lower cognitive function.
Time Frame
15 minutes
Title
Neuropsychiatric Inventory Nursing Homes - NPI-NH
Description
Care home staff will be interviewed to measure the neuropsychiatric symptoms of people with dementia in care homes. Data is collected about a range of symptoms from A-J including delusions, anxiety, aberrant motor behaviours, disinhibition. If a symptom is present, the frequency is scored from 1 (rarely) - 4 (very often), the severity is scored from 1 (mild) - 3 (severe). Frequency x severity provides an NPI score for each present symptom which is totalled. Occupational disruptiveness is also scored for a present symptom from 1 (not at all) - 5 (very severe). Occupational disruptiveness scores are totalled to provide an overall score.
Time Frame
12 minutes
Title
EuroQoL - EQ-5D-5L - self completion
Description
Residents will respond to which level they perceive in five domains (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) with level 1 (no problem) to level 5 (extremely). Each number representing a level will develop a code (e.g. 11111 would indicate no problems in health related quality of life). These scores can then be formulated into an index value.
Time Frame
5 minutes
Title
EuroQoL - EQ-5D-5L - proxy
Description
The same measure as above to assess proxy health related quality of life. This will be completed by a care staff member and scoring will be as above.
Time Frame
5 minutes
Title
Barthel Index (BI)
Description
A survey link will be sent out to care staff to measure the perceived functional abilities of the individuals with dementia such as feeding, bathing etc. Care staff will be asked the questions to provide their opinions on one domain (activities of daily living) with 10 items. Scores range between 0 and 100. A higher score indicates a better outcome with higher levels of independence.
Time Frame
10 minutes
Title
Job Satisfaction Index (JSI)
Description
A survey link will be sent out to care staff to measure job satisfaction based on 18 statements using five categories from strongly agree - strongly disagree.
Time Frame
10 minutes
Title
Maslach Burnout Inventory - Human services (MBI-HSS)
Description
A survey link will be sent out to care staff to measure burnout. Questions are based around three areas: emotional exhaustion, depersonalisation and personal accomplishments. There are a total of 22 questions related to how one feels in their job, on a scale from 0 (never) - 6 (every day). Average scores are calculated.
Time Frame
10 minutes
Title
Qualitative semi-structured Interviews
Description
A semi-structured interview with care staff will be carried out at baseline in both groups until data saturation is met. This interview consists of questions about the concept of quality of care and job satisfaction. Another interview will be carried out with all care staff participants in the intervention group at the end of the music therapy treatment to evaluate the music therapy process.
Time Frame
10 - 20 minutes
Title
Client Service Receipt Inventory (CSRI Dementia)
Description
A measure of the cost effectiveness of the music therapy in care homes. This instrument collects information about service usage of residents, medication usage and overall care home costs.
Time Frame
15 minutes
Title
Total number of staff at the care home
Description
The total number of staff at each care home is collected in both groups, pre and post to examine staff retention and turnover.
Time Frame
2 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kiera M Kenny, MSc
Phone
+44 (0) 1223 695405
Email
kk500@pgr.aru.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Ming Hung Hsu, PhD
Email
ming-hung.hsu@aru.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Odell-Miller, PhD
Organizational Affiliation
Anglia Ruskin University
Official's Role
Study Director
Facility Information:
Facility Name
Ridgemount
City
Banstead
State/Province
Surrey
ZIP/Postal Code
SM7 2BQ
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Oakleigh, Godstone
City
London
State/Province
Surrey
ZIP/Postal Code
RH9 8BD
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Greenacres, Banstead
City
London
State/Province
Surrey
ZIP/Postal Code
SM7 2BQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leigh Arney
Facility Name
Hatfield House
City
Doncaster
ZIP/Postal Code
DN7 6JQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tanya Burnett
Facility Name
Simon Marks Court
City
Leeds
ZIP/Postal Code
LS21 1RJ
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Oak Tree Lodge
City
Leeds
ZIP/Postal Code
LS9 6BT
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Kimberly Court
City
Newquay
ZIP/Postal Code
TR7 1JG
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Wharfside
City
Otley
ZIP/Postal Code
LS21 1RJ
Country
United Kingdom
Individual Site Status
Completed
Facility Name
St Anne's
City
Saltash
ZIP/Postal Code
PL12 6DJ
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Prior Bank
City
Sheffield
ZIP/Postal Code
S11 9AB
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Herries Lodge
City
Sheffield
ZIP/Postal Code
S5 8TT
Country
United Kingdom
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be anonymous
Links:
URL
https://bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-015-0082-4
Description
This study has tested similar methods to those that are being used in the current study
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5491018/
Description
This study has informed the current study of outcome measures to use
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7248378/
Description
This study details the effects of music therapy on dementia and highlights the need for further trials

Learn more about this trial

Managing the Needs of Care Home Residents With Dementia Through a Music Therapy Intervention

We'll reach out to this number within 24 hrs