A Realist Evaluation of the Feasibility of a Digital Music and Movement Intervention for Older People Living in Care Homes
Phase: NA
Conditions: Aged, Older Adults, Healthy Aging, Aging
Sponsor: University of Stirling

 
Ethics Application Form 
Are you a member of staff, a postgraduate research student, a postgraduate taught student or an undergraduate student?
Staff
Postgraduate Research Student
Postgraduate Taught Student
Undergraduate Student
Please enter your job title
Professor
First Name
Anna
Surname
Whittaker
Division
Faculty of Health Sciences and Sport
Faculty
Email
a.c.whittaker@stir.ac.uk
Applicant details
Applicant details
Does your application involve any of the following?
A new project with Human participants
A new project with Animals
A project that has already received ethical review
An application or an amendment to a Project Licence
None of the above
Type of application
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Ofﬁcial Project title: A Realist Evaluation of the Feasibility of a Digital Music and Movement Intervention for Older People Living in Care 
Homes  
Short title: danceSing Care evaluation: Testing the feasibility
NCT number: NCT05559203
Protocol and analysis plan – Ethics application signed and submitted 19/11/21
Reference #: NICR 2021 3735 3607
Downloaded 8/8/24

Additional factors
Does the proposed project involve reproducing copyrighted work in published form (other than brief citation)?
Does the proposed project involve activities which could temporarily or permanently damage or disturb the
environment, or archaeological remains and artefacts?
Does the proposed project involve a potential conflict of interest or raise ethical issues regarding the source of
funding or where the publication of research data may be restricted?
None of the above
If your project involves NHS patients, staff, data or premises we would recommend using the HRA Decision Tool to determine whether
NHS Research Ethics Committee approval will be required.
Please indicate those that apply to your study or select none of the above
Requires approval by an NHS Research Ethics Committee (REC)
Requires approval ONLY by NHS Research and Development (R&D) with an IRAS form
Requires approval ONLY by NHS Research and Development (R&D) - no IRAS form is required
Health care settings (in the UK or overseas)
Clinical trial or an investigational medicinal product
Clinical investigation and/or study of a medicinal product
Human tissue samples or other human biological samples
Imaging investigations (MRI, ultrasound)
Physical examinations (blood pressure, pulse, respiratory rate)
Physical tests (other than EEG, BioPac, fNIRS)
Computer tests where there are potential health consequences (dementia, sleep apnoea, depression tests)
Filming or photography (as part of a health research study or in a health setting/context)
Sample-taking (urine, blood, hair, muscle biopsy)
Ingestion of substances, fluids or alcohol
Health related questionnaires, surveys or interviews where there is the potential to diagnose new health related conditions.
None of the above
NHS Invasive or Clinical research
Please enter the short title of your project (max 200 characters)
danceSing Care evaluation
Project details
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Please enter the full title of your project
danceSing Care evaluation
Staff - If you have a Worktribe record for this project please make sure the titles are the same.
Please add the Worktribe reference for this project
n/a
Are there collaborators involved in the study?
Yes
No
You will be asked to add details of your collaborators later in the form.
Project funder
n/a
Please enter the type of funding
Please Select...
Funding details
Project start date
03/09/2021
Project end date
31/05/2023
Project duration
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If different from the project start and end dates
Expected start of data collection
10/01/2022
Expected end of data collection
30/12/2022
If the proposed project poses any particular physical risks to the researcher(s) or research participants a risk assessment must be
signed off by your supervisor or line manager prior to commencing fieldwork.
Has a health and safety risk assessment been successfully completed?
Yes
Not applicable
In progress
Health and Safety
Please provide a summary of your project (~half page, one page maximum) describing the topic, and
main objectives, a summary of your proposed methodology (e.g. fieldwork, experimental procedures,
surveys, interviews, focus groups, standardised testing, video or audio recording).
Topic
danceSing Care is a creative health and wellbeing company that offers the care sector bespoke, on-demand 
music and movement resources. This offering is likely to have significant health, social and mental wellbeing 
benefits but to date this is largely anecdotal. DanceSing Care would like to conduct a more rigorous 
research project to help promote and endorse their current offering. 
Main aims/objectives
The SPARKLE team will work with danceSing Care to develop a mixed methods research project (qualitative 
and quantitative research) to evaluate the impact of their music and movement provision on the health and 
wellbeing of older people in care homes. 
Project description
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Methods
The University has a number of pre-approved protocols for common research scenarios. If you will be following one of the University's
protocols please indicate which one here. 
1. Develop a toolkit of measures – We will create an advisory group (from our existing contacts through 
Stirling 1000 Elders run by Prof Whittaker, danceSing Care staff, care home employees) to develop, pre-trial 
and refine appropriate measures for this age group and sector and ensure outcomes of interest to the 
advisory group as being assessed. Based on our experience, the toolkit is likely to include quantitative 
measures of desired outcomes (i.e., health, wellbeing, social connectedness, loneliness) and qualitative 
methods such as open-ended questions delivered by online surveys - but potentially also some physical 
tests (chair sit to stand, mobility e.g. timed up and go) if we are able to visit the care homes - Covid19 
permitting. We will assess measures that can be implemented by older people themselves with minimal input 
from carers, can be completed over a relatively short time frame. We will also develop a semi-structured 
interview/focus group schedule for use after the intervention. 
ADDED [ Regarding the physical function measures, we would be potentially asking participants to 
undertake some simple tests of physical function.  These are still being decided by the Advisory Group.  
These might include some or all of walking speed over 4m, timed-up-and-go walking speed (from seated, 3m 
then back to seated), standing balance tests (ability to balance in different positions for 30s), and number of 
sit-to-stand transitions you can complete in 30 seconds.  All tests would be described to participants before 
conducting them and conducted by trained researchers. Physical function testing would only be offered to 
participants whom their care team deem would be safe to take part in this aspect. We will minimise the 
number of tests to reduce participant burden and participants would be given regular breaks if we are 
running more than one of these tests and in a session that is more than 30 minutes duration. These tests 
would be once prior to the danceSing Care programme starting and once again at the end after the 
programme 12 weeks later and take 30min to an hour. ]
2. Evaluate danceSing Care – We will recruit older people in care homes who are new to the danceSing 
Care online programme to complete the toolkit at baseline and then at follow-up at 12 weeks. We will 
determine an appropriate sample size based on measures included in the toolkit, and our previous project 
experience but as this is a bit like a feasibility study, we will recruit as many older adults as possible at a 
single site. A sub-sample of participants and care home staff will take part in more in-depth qualitative data 
collection on barriers and facilitators of the programme through a semi-structured interviews or focus 
groups, respectively, at the end.  We will then conduct statistical and qualitative thematic analysis on the 
data from the toolkit at baseline and follow-up to examine change over time. 
Phase 2: For a more robust design, a control group will be sought which will include another site or a group 
due to start the program later. 
After an initial group have run through the baseline, 12w access to the danceSing Care programme and 
follow-up design we will recruit further participants from different care home sites and randomise them to 
intervention or wait-list control. The design will be the same as above, except the wait-list control group will 
start the 12w access to danceSing Care after the intervention group have completed this.
Please be aware that if your methodology changes during your research, it is your responsibility to submit an amendment to your
approved application. See the Information button for further advice.
Applicants must confirm that they have read and understood the University's guidance on GDPR
and that the necessary steps have been considered to protect the data of your participants.
Review the University's guidance on GDPR
I have read and understood the University's GDPR guidance
GDPR
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Please indicate those that apply to your project
Involves children or vulnerable adults
Involves personal data that has been obtained without the knowledge of the data
subjects
Processing of bio-metric or genetic data
Large scale processing of criminal convictions or special categories of personal
data?
Processing of personal data involving new technologies or novel applications of
existing technologies
Combining or matching personal data obtained from multiple sources
Tracking geo-location
Using personal data in a way that could significantly affect or have an impact on
an individual
Jeopardising the physical health or safety of individuals
Systematic monitoring of publicly accessible areas
Profiling or automated decision-making on a large scale where significant
decisions are made impacting on people
None of the above
Please upload your completed Data Protection Impact Assessment (DPIA)
Documents
Type
Document Name
File Name
Version
Date
Version
Size
Data Protection Impact
Assessment
Data Protection Approval
Form_completed_danceSing Care
Data Protection Approval
Form_completed_danceSing Care.docx
13/09/2021
1
94.4
KB
Provide details of your participant population and the number of participants required
Include brief characteristics as well as principal inclusion and exclusion criteria.
Inclusion for online survey: Aged 60+ living in a care home, capacity to consent, deemed 
capable of taking part in the online danceSing care resources and sit-to-stand/walking speed 
tests safely. Care homes complete their own risk assessment of patients for all activities) 
Inclusion for follow-up interview/focus groups: Aged 60+ living in a care home and took part in 
the online survey part, capacity to consent. OR care home staff e.g. activities managers 
involved in setting up residents with the danceSing Care online resources and helping to recruit 
participants.
Exclusion:  unable to consent, unable to read English, unable to safely take part in online light 
physical and social activity or any testing as assessed by care home staff.
Participants, recruitment and location
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Describe how and from where participants will be recruited.
danceSIng Care has recruited care home organisations in Scotland and North of England to 
take part in this evaluation. They will liase with care home managers and activity coordinators 
about the most suitable home for the initial phase.  Care home staff independently conduct risk 
assessments for all activities and would use this for each resident to gauge suitability of the 
danceSing online activities for each person (out-with whether they take part in the research or 
not).
Then within the home the research team and danceSing Care will liase with staff about potential 
residents to approach with the information sheet. Care home staff will then distribute the PIS 
and its simplified poster version to engage initial interest. 
We will use the simple poster as well as the PIS with care home staff and discuss with care 
home staff in a meeting of those who will be engaged in recruitment about how to talk about the 
study and answer any questions before they start recruitment.  In this meeting we will 
emphasise the importance of not trying to coerce participation in those who seem reluctant and 
also underline that non-participants can still take part in the danceSing care activities even if 
they opt not to take part in the research element of the project. 
Interested residents will then be contacted by the researchers via the care team to invite them 
to agree to take part, and consent and access the online baseline survey. This survey will 
include the PIS electronic consent form before moving on to the specific measures.   
For the foreseable future these activities will be online but from the initial single arm recruitment 
phase (phase 1) we would like to explore the possibility of utilising PhD students in face to face 
data collection (Covid19 permitting access to homes) and training local collaborators (peers, 
care staff) as citizen scientists to undertake a few physical testing measures, e.g., sit-to-stand 
and walking speed. However, this needs to be explored with the Advisory Group for feasibility 
before adding this in as measures so is part of the emergent design. We have added details of 
physical function testing to the PIS.
Phase 2 will recruit in the same way but will be at a different care home, or with residents who 
have not yet used the danceSing Care resources previously.
Describe where the research activities will take place
for example: online, in a classroom, in a sports facility
Online in care homes for the foreseable future for older people for survey (JISC) and interviews 
(MSTeams)
Online in MSTeams for care home staff focus groups.
Covid-permitting some brief physical function tests (walking speed, sit to stand) in the care 
home but this remains to be determined with the Advisory group.
Describe any incentive participants may receive for participation
For applications that will provide Psychology Undergraduate students with research tokens please ensure that your study follows the
Undergraduate Student Participation in Research in the Psychology Division Research Tokens Protocol available from the approved
protocol section of the website. You should make reference to the protocol in your answer here. 
Unlimited access to the danceSing Care online resources for the duration of the project.
Some knowledge about how their own walking speed and sit-to-stand performance compares to other 
older people.
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Does your proposed study involve vulnerable groups?
Yes
No
Will you be obtaining membership of the Protecting Vulnerable Group (PVG) scheme or a
Disclosure?
Yes
No
Existing PVG member
Please provide confirmation or explain how Protecting Vulnerable Groups (PVG) scheme, or a
Disclosure will be obtained:
All research team members who will be directly involved with study participants on their own 
without care home staff present will be required to register with the PVG scheme prior to the 
commencement of project activities if they will have any face to face contact alone. Currently 
the care home does not envisage that this will be required as researchers will not be alone with 
residents.
Consent
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Will you obtain consent from or on behalf of participants? When, where and how?
Remember to include how long you will allow participants to decide whether or not to take part.
ADDED [Capacity to consent will be assessed by residents’ usual care team, including care 
manager/activities coordinator as is usual practice in this setting including in studies we have 
previously had approved by NHS ethics committees. This involves their in-depth knowledge of 
the potential participant, their care plan, their current medical diagnoses including dementia, 
and their medication as well as their assessment of ability to understand the study when it is 
discussed with them. This is standard in NHS/care settings to rely on the expertise of the health 
professionals working directly with patients rather than conducting additional screening 
assessments at this stage (which of course would require consent). Only participants deemed 
to have capacity to consent will be approached for recruitment. Where this is uncertain, an 
initial approach to discuss the study will be used to help assess capacity.  Only those deemed 
to have capacity at this stage will be re-approached to confirm recruitment. ]
Potential participants will have 48hr from initial approach to decide if they are interested in 
taking part, including time to ask the care staff and/or research team questions about the 
project. Care staff will then reapproach after 48hr and give access to the online survey to those 
who are. 
The electronic consent form following reiteration of the PIS will be at the start of the online 
survey. 
ADDED [We have also now added an additional opt in/out consent to physical function testing 
at the end of the survey.
Verbal assent will be checked prior to conducting any physical function tests.]
Similarly, for the sub-group we invite to interviews (older people) or focus groups (care home 
staff) we will give them 48hr from invitation and reminder via the PIS and consent form emailed 
through and then care staff will reapproach the older people with the consent form for 
interviews if they express an interest. Staff will be asked to consent via the consent form and 
email this back to us if they are interested in taking part in a focus group.
How will consent be recorded?
If written consent will not be obtained, justify it here
Online in the survey for older people, for the interviews/focus groups we will email the consent 
form to the care home for completion and return by participants. 
ADDED [ Verbal assent will be rechecked by the researchers before any physical testing 
sessions or interviews. We have also now added an additional opt in/out consent to physical 
function testing at the end of the survey and an additional paper consent form for physical 
function testing alone. ]
Permissions
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If any additional consent and permission procedures are required please provide details
For example, permissions to conduct field sampling or from local authorities to access schools
Written agreement between danceSing Care, ourselves and the partner care home 
organisations to run the evaluation project will be sought by danceSing Care in collaboration 
with the research team prior to initiating recruitment. It is envisaged that visits to interested care 
homes and online meetings with staff will help to explain and embed the project. Care homes will 
conduct their own risk assessments to assess suitability of residents to take part in the 
danceSing Care activities and our own data collection. 
ADDED [We have discussed COVID risk with the Care Homes operations manager and 
formalised the Covid risks and mitigations into a risk assessment which has now been approved 
(attached) and will follow the care homes’ guidelines regarding this as well as exchanging and 
recording their own Risk Assessments regarding visits. ]
Describe any ethical issues and how you will mitigate them
Participants (older adults only) may potentially become upset by some of the survey questions 
about wellbeing/mental health although in our experience this is rare and manageable by 
participants themselves/care home staff. However, the right to withdraw at any time will be 
reinforced and we will also supply contact information for the PI who is a Health Psychologist, 
should they wish to discuss this, and we will recommend that if they are upset by any particular 
questions that they raise this with their GP. 
Are there risks of foreseeable harms that may be caused to participants and/or third parties
For example, landowners, institutions, carers and families
Yes
No
Ethical implications
Will the proposed research involve the deception of participants?
Yes
No
Will the proposed research involve concealment or covert observation?
Yes
No
Is the project design emergent? e.g. will elements of the research be developed during the process of the research?
Yes
No
Methodologies
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Provide details of your emergent design
The psychometric tools and specific questions making up the online survey toolkit and the 
interview/focus group questions will be developed with our advisory panel as the initial part of 
the study. However, none of these will be diagnostic tools and will likely be similar to those used 
in our other approved projects (GOALD GUEP 2021 2080 2106, and CSO Covid19 GUEP 905).  
We have attached a draft list of what the survey is likely to include and a draft example of likely 
interview/focus group questions. We will be refining this with our Advisory group and ensuring it 
is not too burdensome. 
We will potentially also be asking participants to undertake some simple tests of physical 
function.  These are still being decided by the Advisory Group.  These might include some or all 
of walking speed over 4m, timed-up-and-go walking speed (from seated, 3m then back to 
seated), standing balance tests (ability to balance in different positions for 30s), and number of 
sit-to-stand transitions you can complete in 30 seconds.  We will minimise the number of tests to 
reduce participant burden and participants would be given regular breaks if we are running 
more than one of these tests and in a session that is more than 30 minutes duration.  
These tests would be once prior to the danceSing Care programme starting and once again at 
the end after the programme 12 weeks later. 
How will the results from this study (include feedback to participants) be disseminated?
We will work with the advisory group to produce outputs (including a report) for the participants 
which will also be used for marketing purposes to promote and roll-out the danceSing Care 
programme more widely. The full findings will be submitted as a peer reviewed research 
publication and potential conference posters for wider dissemination to academics and 
stakeholders which participants can request.
ADDED [Negative or null findings are just as important for danceSing care and for ourselves in 
terms of informing the development of ongoing and future interventions therefore these will be 
treated openly and honestly in the same way as any positive data. While danceSing care may 
be more inclined to tweet particularly about the positive findings from the research and use 
these in marketing, to avoid biased reporting overall the report provided to danceSing Care to 
help the development of their services and the associated research article will present ALL 
findings for their usage. The anonymised data will also be stored and linked to the research 
article following publication for open access. ]
Dissemination
Does the proposed work involved the remote acquisition of data from or about human
participants using the internet and its associated technologies?
Yes
No
Data collection methods
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Please give details
survey will be online twice in older people, a sub-group of participants will be invited for 
an online interview/focus group - older people will take part in interviews, care staff in 
focus groups
Does your project involve data from social media?
Yes
No
Does the proposed work involve collecting or accessing records of, personal or confidential information concerning individuals?
Yes
No
Describe how the anonymity of participants and the confidentiality of data will be protected and the specific methods to be used for
this, both through the research and in the dissemination of findings.
The online survey will be confidential and identifying information (name, DOB) used to 
match with the follow-up survey will be removed from the downloaded datafile prior to 
analysis.  This information will be stored in a password-protected file on OneDrive by the 
research team and will not be accessible by anyone else. Data will be stored separately 
on OneDrive without identifying person information.  
Semi-structured interview/focus group recordings will be transcribed and transcriptions 
anonymised prior to data analysis. Original recordings will be destroyed and 
transcriptions will be stored in password-protected files on OneDrive.
Who will have access to identifiable information? Describe any potential use of the identifiable data by others.
only the research team and any care staff assisting with measures completion who 
already know the participants will have access to the raw data including this information. 
Processed data will be anonymised before revealing findings to danceSing Care.
Indicate if there are any conditions under which privacy or confidentiality cannot be guaranteed or, if confidentiality is not an issue
in this research, explain why.
n/a
Collection of confidential information
Does the proposed work involve the recording of participants through the use of audio visual methods?
Yes
No
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Please give details
Interviews/focus groups will be videorecorded on MSTeams or Zoom depending on the 
preference of the participants.  Software automatically produces a text transcript of the 
audio portion of the recording which will be cleaned and used as qualitative data for 
analysis to address project research questions.
Will an external contractor be involved e.g. transcription services, interpreters or fieldworkers?
Yes
No
Briefly describe the methods of data analysis
Descriptive statistics for the sample demographics and baseline questionnaire responses 
followed by Repeated measures ANOVA on questionnaire ratings/scores from pre-
intervention to post-.
Thematic analysis of answers to open-ended questions in the survey and interview/focus 
group transcriptions.
Data analysis
Briefly describe the methods of data storage
All data will be downloaded from the survey host, anonymised by ID and transferred into an 
SPSS file. A separate list matching ID and contact details for follow-up will be stored separately. 
All files will be password protected stored in OneDrive accessible only by the research team. 
Similarly audiovisual files will be transcribed then anonymised and stored in OneDrive. Original 
recordings will be destroyed. All data will be stored for 10 years. 
Data storage
Does the principal investigator or any other investigator/collaborator have any direct personal involvement (e.g. financial, share-
holding, personal relationship etc.) in the organisations sponsoring or funding that research that may give rise to a potential conflict
of interest?
Yes
No
Conflict of interest
Internal collaborators
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First Name
Gemma
Surname
Ryde
Division
Faculty of Health Sciences and Sport
Please enter details of University of Stirling co-applicants
First Name
Jenni
Surname
Connelly
Division
Faculty of Health Sciences and Sport
Please enter details of University of Stirling co-applicants
First Name
Len
Surname
De Nys
Division
Sport
Please enter details of University of Stirling co-applicants
First Name
Esther
Surname
Ofosu
Please enter details of University of Stirling co-applicants
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Division
Sport
First Name
Claire
Surname
Hunt
Organisation
danceSing Care
Please add details of any external co-applicants
First Name
Natalie
Surname
Garry
Organisation
danceSing Care
Please add details of any external co-applicants
External collaborators
The University provides a range of template documents. We would strongly recommend that you use the templates that are available
on the research ethics and integrity website.
Documents
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Please upload your participant information sheet(s)
Documents
Type
Document Name
File Name
Version
Date
Version
Size
Participant
information sheet
danceSing Care Participant Information Sheet
Online Survey v2
danceSing Care Participant Information Sheet
Online Survey v2.docx
17/11/2021
2
81.4
KB
Participant
information sheet
danceSing Care Participant Information Sheet
Online Interview v2
danceSing Care Participant Information Sheet
Online Interview v2.docx
17/11/2021
2
88.9
KB
Participant
information sheet
danceSing Care Staff Participant Information
Sheet Focus Groups v2
danceSing Care Staff Participant Information
Sheet Focus Groups v2.docx
17/11/2021
2
88.5
KB
Please upload your consent sheet(s)
Documents
Type
Document Name
File Name
Version
Date
Version
Size
Consent
Form
danceSing
Care_Participant_consent_form_int_FG_v2
danceSing
Care_Participant_consent_form_int_FG_v2.docx
17/11/2021
2
1.3
MB
Consent
Form
danceSing
Care_Participant_consent_form_PhysFunct_v1
danceSing
Care_Participant_consent_form_PhysFunct_v1.docx
17/11/2021
1
1.3
MB
Please upload copies of recruitment material(s)
Documents
Type
Document Name
File Name
Version
Date
Version
Size
Participant recruitment
materials
danceSing Care Evaluation PIS poster v2
danceSing Care Evaluation PIS poster v2.pptx
17/11/2021
2
519.2
KB
Participant recruitment
materials
danceSing Care Evaluation posters A4
staffresidents_v1
danceSing Care Evaluation posters A4
staffresidents_v1.pptx
17/11/2021
1
2.1
MB
Please attach copies of questionnaire(s), interview or focus group guides
Documents
Type
Document Name
File Name
Version
Date
Version
Size
Interview schedule/topic
guide
Interview_Focus Group potential
questions
Interview_Focus Group potential
questions.docx
13/09/2021
1
1.3 MB
Interview schedule/topic
guide
Sample survey_full_latest
draft_v2_17.11.21
Sample survey_full_latest
draft_v2_17.11.21.docx
17/11/2021
2
949.1
KB
Interview schedule/topic
guide
danceSing Care physical function
tests_draft
danceSing Care physical function
tests_draft.docx
17/11/2021
1
41.6
KB
If relevant, please attach copies of debrief information
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If relevant, please attach other documentation
Documents
Type
Document Name
File Name
Version
Date
Version
Size
Other
documentation
RA0X-Physical Function-testing-dynamic-and-
static
RA0X-Physical Function-testing-dynamic-and-
static.docx
17/11/2021
1
30.4
KB
Other
documentation
COVID19 risk assessment for fieldwork phys
funct testing
COVID19 risk assessment for fieldwork phys funct
testing.docx
17/11/2021
1
72.9
KB
Other
documentation
Response to Ethics
Response to Ethics.docx
17/11/2021
1
25.8
KB
Signing the form will lock the form and prevent further editing. If you choose to unlock the form all signatures will be invalidated
and requests will need to be made again. 
Please sign your application
Signed: 
Signed: This form was signed by Anna Whittaker (a.c.whittaker@stir.ac.uk) 
This form was signed by Anna Whittaker (a.c.whittaker@stir.ac.uk) on 
on 19/11/2021 14:12
19/11/2021 14:12
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