Cognitive ImpairmentNCT05176444
Managing the Needs of Care Home Residents With Dementia Through a Music Therapy Intervention
A study testing Music therapy in people with Cognitive Impairment and Dementia, run by Anglia Ruskin University at 11 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 105 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment, Dementia
- What is being tested?
- Music therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 11 sitesUnited Kingdom
- Study dates
- 4 Jul 2022to 13 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 105 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 9Show fewer
- 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.
Who cannot join
- 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.
- Staff who cannot adequately answer on behalf of the residents due to lack of knowledge of the residents.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United Kingdom11 sites
Ridgemount
Banstead, Surrey, SM7 2BQ
Hatfield House
Doncaster, DN7 6JQ
Simon Marks Court
Leeds, LS21 1RJ
Oak Tree Lodge
Leeds, LS9 6BT
Oakleigh, Godstone
London, Surrey, RH9 8BD
Greenacres, Banstead
London, Surrey, SM7 2BQ
Kimberly Court
Newquay, TR7 1JG
Wharfside
Otley, LS21 1RJ
St Anne's
Saltash, PL12 6DJ
Prior Bank
Sheffield, S11 9AB
Herries Lodge
Sheffield, S5 8TT
About this study
Official title: Managing the Needs of Care Home Residents Through a Music Therapy Intervention: A Non-randomised Feasibility Trial
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.
Read the 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.
.
- Conditions
- Cognitive Impairment, Dementia
- Being tested
- Music therapy
- Keywords
- Dementia, Music therapy, Cognition, Care home, Quality of care, Non-pharmacological intervention, Needs, Neuropsychiatric symptoms
- Medical subject headings
- Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Music therapy intervention | Experimental | Music therapy Receives: Behavioral: Music therapy |
| Control group - standard care | No intervention | Standard care for residents with cognitive impairment. Staff will not receive music therapy training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 minutes
Secondary outcomes (10)
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.
Measured: 15 minutes
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.
Measured: 12 minutes
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.
Measured: 5 minutes
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.
Measured: 5 minutes
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.
Measured: 10 minutes
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.
Measured: 10 minutes
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.
Measured: 10 minutes
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.
Measured: 10 - 20 minutes
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.
Measured: 15 minutes
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.
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start4 Jul 2022
- Primary completion30 Apr 2024
- Study completion13 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anglia Ruskin University
- Sponsor type
- University, hospital or other
- Collaborators
- Anchor Trust, The Utley Foundation
- Responsible party
- Sponsor
- Investigators
- Helen Odell-Miller, PhD, Study director, Anglia Ruskin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05176444
- Sponsor's protocol ID
- U4-11662
- Status last verified
- Jan 2024
- First submitted
- 15 Dec 2021
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be anonymous
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managing the Needs of Care Home Residents Through a Music Therapy Intervention: A Non-randomised Feasibility Trial
- ClinicalTrials.gov ID
- NCT05176444
- Acronym / sponsor ID
- U4-11662
- Conditions
- Cognitive Impairment, Dementia
- Keywords
- Dementia, Music therapy, Cognition, Care home, Quality of care, Non-pharmacological intervention, Needs, Neuropsychiatric symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Anglia Ruskin UniversityUniversity, hospital or other
- Collaborators
- Anchor Trust, The Utley Foundation
- Study start
- 4 Jul 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 13 May 2024 (actual)
- First posted
- 4 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music therapy intervention | Experimental | Behavioral: Music therapyMusic therapy |
| Control group - standard care | No intervention | –Standard care for residents with cognitive impairment. Staff will not receive music therapy training. |
Who may qualify
- Ages
- 18 to 105 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- Participants must be aged 18+ years
Key exclusion criteria (2 listed)
- 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.
- Staff who cannot adequately answer on behalf of the residents due to lack of knowledge of the residents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music therapyIndividual 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. | Behavioural | Music therapy intervention |
Primary outcome
Camberwell Assessment of Needs in the Elderly - CANE
Time frame: 15 minutes
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.
10 secondary outcomes
Standardised Mini Mental State Examination - SMMSE
Time frame: 15 minutes
Neuropsychiatric Inventory Nursing Homes - NPI-NH
Time frame: 12 minutes
EuroQoL - EQ-5D-5L - self completion
Time frame: 5 minutes
EuroQoL - EQ-5D-5L - proxy
Time frame: 5 minutes
Barthel Index (BI)
Time frame: 10 minutes
Job Satisfaction Index (JSI)
Time frame: 10 minutes
Maslach Burnout Inventory - Human services (MBI-HSS)
Time frame: 10 minutes
Qualitative semi-structured Interviews
Time frame: 10 - 20 minutes
Client Service Receipt Inventory (CSRI Dementia)
Time frame: 15 minutes
Total number of staff at the care home
Time frame: 2 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- This study has tested similar methods to those that are being used in the current studyLink provided by the sponsor.
- This study has informed the current study of outcome measures to useLink provided by the sponsor.
- This study details the effects of music therapy on dementia and highlights the need for further trialsLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data will be anonymous
Related trials for Cognitive Impairment
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen Odell-Miller, PhD study director
Anglia Ruskin University
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music therapy in people with Cognitive Impairment and Dementia, run by Anglia Ruskin University at 11 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Camberwell Assessment of Needs in the Elderly - CANE (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.