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Raising Quality of Care for People With Cognitive Impairment in Care Homes Through Music Therapy.

Sponsor
Anglia Ruskin University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05176444
Collaborator
Anchor Trust (Other), The Utley Foundation (Other)
84
Enrollment
12
Locations
2
Arms
3.9
Anticipated Duration (Months)
7
Patients Per Site
1.8
Patients Per Site Per Month

Study Details

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 quality of care in care homes. 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Music therapy
 N/A

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 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?

  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?

  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 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 will be invited to receive twenty 30-minute individual music therapy sessions across 12 weeks. The therapy will be video recorded for training purposes. Therapists will work with the residents to learn about their needs and 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 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 (Hsu et al. 2015). 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 receive music therapy first. There will be 42 participants in this group (24 with cognitive impairment, 18 care home staff). Subsequently, the remaining six care homes will then receive music therapy, with the same amount and ratio of participants. Pre data collection will take place in all care homes prior to the study and post data collection will take place once music therapy has ended in the first six care homes. This forms the control trial to compare music therapy to traditional care.

Implications:

The study has the potential to improve the lives of care home residents with cognitive impairment. 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 (Moreno-Morales et al. 2020). The evaluation of this study will be used to develop a model of 'music therapy programmes 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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Study Design

Study Type:
Interventional
Anticipated Enrollment :
84 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Raising Quality of Care and Quality of Life for People With Cognitive Impairment in Care Homes Through a Music Therapy Intervention: A Non-randomised Feasibility Trial
Anticipated Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Music therapy intervention

Music therapy

Behavioral: Music therapy
Practical music therapy sessions across 12-weeks with people with cognitive impairment. Music therapy training for care home staff across 12-weeks.
No Intervention: Control group - standard care

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

Outcome Measures

Primary Outcome Measures

  1. Camberwell Assessment of Needs in the Elderly - CANE [15 minutes]

    For people with cognitive impairment - to measure the quality of care in care homes by assessing individual needs

Secondary Outcome Measures

  1. Standardised Mini Mental State Examination - SMMSE [10 minutes]

    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.

  2. Neuropsychiatric Inventory Nursing Homes - NPI-NH [10 minutes]

    Care home workers will be interviewed to measure the neuropsychiatric symptoms of people with cognitive impairment in care homes.

  3. EuroQoL - EQ-5D-5L - self completion [10 minutes]

    Residents with cognitive impairment will answer questions in five domains (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) to measure health related quality of life

  4. EuroQoL - EQ-5D-5L - proxy [10 minutes]

    The same measure as above to assess proxy health related quality of life. This will be completed by a care staff member.

  5. Bristol Activities of Daily Living Scale [10 minutes]

    A researcher will collect data on the functional abilities of the individuals with dementia such as feeding, bathing etc. Care staff will be asked the questions to provide their opinions on each of the domains.

  6. Job Satisfaction Index [10 minutes]

    Organisational outcome measure to assess the job satisfaction of care home staff.

  7. Maslach Burnout Inventory - MBI [10 minutes]

    Organisational outcome measure to measure burnout in care home staff.

  8. Qualitative semi-structured Interviews [20 minutes]

    The researchers have designed a topic guide to conduct online semi-structured interviews with staff, pre and post intervention. The topic guide will explore care home staff's perceptions and opinions of music therapy. A thematic analysis will be used to identify patterns and trends.

  9. Revised Modified Conflict Tactics Scale [10 minutes]

    This scale has been adapted to measure facets of elderly abuse in care homes such as threats or neglect. The questionnaire is for care to staff to complete based on whether they have witnessed incidents outlined in the scale.

  10. Client Service Receipt Inventory [15 minutes]

    To measure the cost effectiveness of the music therapy intervention measure

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 105 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Oakleigh, Godstone London Surrey United Kingdom RH9 8BD
2 Greenacres, Banstead London Surrey United Kingdom SM7 2BQ
3 Silver Court, East Grinstead London West Sussex United Kingdom RH19 1PD
4 Hatfield House Doncaster United Kingdom DN7 6JQ
5 Simon Marks Court Leeds United Kingdom LS21 1RJ
6 Oak Tree Lodge Leeds United Kingdom LS9 6BT
7 Kimberely Court Newquay United Kingdom TR7 1JG
8 Teal Beck House Otley United Kingdom LS21 1RJ
9 Manor Court Plymouth United Kingdom PL3 6ND
10 St Anne's Saltash United Kingdom PL12 6DJ
11 Prior Bank Sheffield United Kingdom S11 9AB
12 Herries Lodge Sheffield United Kingdom S5 8TT

Sponsors and Collaborators

  • Anglia Ruskin University
  • Anchor Trust
  • The Utley Foundation

Investigators

  • Study Director: Helen Odell-Miller, PhD, Anglia Ruskin University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Anglia Ruskin University
ClinicalTrials.gov Identifier:
NCT05176444
Other Study ID Numbers:
  • U4-11662
First Posted:
Jan 4, 2022
Last Update Posted:
Jan 4, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Anglia Ruskin University
Dementia, cognitive impairment, music therapy, care home, quality of care, quality of life, psychosocial care
Additional relevant MeSH terms:
Cognitive Dysfunction

Study Results

No Results Posted as of Jan 4, 2022