Quantitative data
Outcome measures will be administered to participants during home visits arranged at times convenient to them. Each visit is expected to take up to two hours. Baseline data collection will be conducted by BD, and follow-up data collection by blinded researchers. All researchers undertaking data collection will have been fully trained in the administration of these instruments.
The following outcome measures have been selected for use in the study. These are summarised in Table 1. All outcome measures will be administered at each of the three time points. Additionally, demographic data will be collected from people with dementia (age, sex, diagnosis, date of diagnosis, ethnicity, education, musical/singing experience) and from carers (age, sex, ethnicity, education, musical/singing experience) at baseline. Measures will be completed by the person with dementia themselves and/or via a proxy rating by the carer. The carer will complete outcome measures about their own mood, quality of life and experience of caring. Some of these measures will be administered by interview and some will be self-completed by the carer.
A large number of outcome measures are included in this study, in order to assess which of them might be most suitable for future use in a full trial. We recognise that data collection may be time-consuming and tiring for participants, and consequently missing data and incomplete measures are expected in some cases. The order and format of the administration of outcome measures is given in Table 2. This order has been chosen so that instruments measuring similar domains are separated, to maximise the range of information included in incomplete data sets. The interview with the carer will take place first, and subsequently the person with dementia will be interviewed while the carer does the self-completed outcome measures.
Quality of Life – Alzheimer’s Disease (QoL-AD) Scale
This 13-item measure asks respondents to rate various aspects of the person with dementia’s life as poor, fair, good or excellent [17]. It will be completed by participants with dementia, and a proxy rating will also be provided by the carer. Each item is scored on a scale from 1 to 4, so the measure yields a total score out of 52, where a higher score indicates a higher quality of life.
EQ-5D-5L
This instrument comprises five questions about health-related quality of life, and a visual analogue scale [18–20]. It will be completed by participants with dementia and carers. The results will be used to calculate Quality-Adjusted Life Years (QALYs) for all participants. The first five questions are scored on a five-point scale and generate a five-digit health state for each participant (e.g. a score of 12345 would indicate no problems with mobility, slight problems with self-care, moderate problems doing usual activities, sever pain or discomfort, and extreme anxiety or depression). The visual analogue scale gives a score out of 100, where a higher score indicates a higher perceived level of overall health.
Dementia Quality of Life (DEMQOL)
This scale asks the person with dementia to rate their quality of life by responding to 29 questions about their feelings, memory and everyday life [21]. The respondent selects “a lot”, “quite a bit”, “a little” or “not at alL” in response to each question. Each question is scored on a scale from 1 to 4, giving a total score out of 116 where a higher score indicates a higher quality of life.
Bristol Activities of Daily Living Scale (BADLS)
The 20-item scale presents the respondent with various descriptions of performance at activities such as cooking, hobbies and personal care, and asks them to rate the person with dementia’s current level of performance [22]. It will be completed as a proxy rating by the carer. Each items is scored on a scale of 0 to 3, and gives a total score out of 60, where a higher score means a higher level of impairment.
Cornell Scale for Depression in Dementia (CSDD)
The 19-item scale assesses symptoms of depression in people with dementia and their severity [23]. It is completed through interviews conducted with the person with dementia and the carer separately, with the interviewer assigning a score based on the severity of symptoms within the past week. For each indicator of depression, absent symptoms score 0, mild or intermittent symptoms score 1, and severe symptoms score 2. The total score is out of 38, where scores above 10 indicate probable major depression, and scores above 18 indicate definite major depression.
Geriatric Depression Scale (GDS-15)
The 15-item version of this scale presents the respondent with “yes/no” questions about how they have been feeling over the past two weeks [24]. It will be completed by people with dementia and carers. Each answer indicative of depression scores one point. A score of 5 or higher is suggestive of a depressive disorder, while a score of 10 or higher is indicative of a probable depressive disorder.
Musical Engagement Questionnaire (MuseEQ)
This scale has 35 items which ask the participant how they have used and engaged with music over the past month [25]. It will be completed by people with dementia. The scale consists of statements such as “I play a song over and over if I like it” and the respondent indicates the extent to which they agree with the statement on a five-point scale, scored from 1 to 5. The total score is out of 175, and a higher score indicates a higher level of musical engagement.
ADAS-Cog
The measure assesses a number of facets of cognitive performance including memory, verbal skills, motor skills, and orientation [26, 27]. It will be completed by the person with dementia. The tests include memorising a list of words, naming familiar objects as they are presented, copying drawn shapes, and following verbal instructions. The interviewer also rates the participant on their verbal fluency, comprehension and ability to concentrate. The total possible score is 70, with higher scores indicating higher levels of cognitive impairment.
Clinical Dementia Rating (CDR)
This instruments gathers data through semi-structured interviews conducted with the carer and the person with dementia [28]. The interviewer uses this data to rate the severity and stage of dementia across six different domains: memory, orientation, judgment/problem solving, community affairs, and home/hobbies. The rating of each of these domains is used to generate an overall CDR score which indicates the level of impairment present: 0 (none), 0.5 (questionable), 1 (mild), 2 (moderate) or 3 (severe).
Quality of the Carer-Patient Relationship (QCPR) Scale
The 14-item measures invites the respondent to state their level of agreement with questions about their relationship with the person for whom they care [29]. It will be completed by carers. The responses are scored from 1 to 5, and the total score is out of 70, with a higher score indicating higher perceived relationship quality.
Carers of Older People in Europe (COPE) Scale
The 15-item scales asks the carer about their experiences of caregiving and its consequences for their physical and mental health [30]. The responses are scored from 1 (never) to 4 (always) and when total scores are calculated they are divided into three subscales which are treated separately: negative impact of caregiving, positive value of caregiving and quality of support.
Short Sense of Competence Questionnaire (SSCQ)
The SSCQ is derived from the Zarit Burden Inventory and evaluates the carer’s experience of caring across seven items [31]. The carer indicates how strongly they agree with the statements in the scale and each item is scored from 1 to 5. A higher score indicates a higher perceived sense of competence.
Client Service Receipt Inventory (CSRI)
The CSRI is a tool to measure consumption of services with a view to estimating their costs for economic analysis [32]. It will be administered in a form adapted to the typical activities of people with dementia and their carers, in order to measure the use of health and social carer resources by each participant. This instrument will be completed by the carer.
Table 1
Summary of outcome measures
Instrument name | Domain measured | Participant | Respondent |
Person with dementia | Carer | Person with dementia | Carer (proxy) | Carer (self) |
QoL-AD | Quality of life | x | | x | x | |
EQ-5D-5L | Health-related quality of life | x | x | x | | x |
DEMQOL | Quality of life | x | | x | | |
BADLS | Activities of daily living | x | | | x | |
CSDD | Depression | x | | x | x | |
GDS | Depression | x | | x | | x |
MuseEQ | Musical engagement | x | | x | | |
ADAS-Cog | Cognition | x | | x | | |
CDR | Dementia severity | x | | x | x | |
QCPR | Caring relationship | | x | | | x |
COPE | Experiences/consequences of caring | | x | | | x |
SSCQ | Experiences of caring | | x | | | x |
CSRI | Use of health/social care | x | x | | x | x |
Table 2
Order and format of outcome measure administration
Person with dementia (by interview) | Carer |
By interview | Self-complete |
1. QoL-AD 2. GDS 3. CDR 4. MuseEQ 5. ADAS-Cog 6. EQ-5D-5L 7. CSDD 8. DEMQOL | 1. QoL-AD proxy 2. GDS 3. CDR 4. QCPR 5. CSRI | 1. COPE 2. SSQC 3. EQ-5D-5L 4. BADLS |
Qualitative data
Previous research into group singing for people with dementia has shown that quantitative measures may not capture the benefits perceived by participants [11, 33]. Qualitative data concerning participants’ experience of the singing groups will be collected during the study using participant observation. BD will conduct structured observations of 3–4 opportunistically selected dyads in each singing group. Each dyad will be the focus of observations three times: in one early session, in one session towards the middle of the group’s course, and in one later session. Detailed notes on the observations will be made after the sessions.
We will also collect qualitative data from a sub-sample of participants through semi-structured interviews. We will aim to interview 10 dyads in total, 12.5% of the 80-dyad intended sample. Dyads will be selected for interview opportunistically and those who do not wish to be interviewed will be free to decline. We will interview at least one dyad from each singing group, and will aim to spread the sample evenly between the groups. Interviews will last 30–45 minutes, and each dyad will be interviewed together where possible. The interview guide will focus on understanding participants’ experience of taking part in the group. Interviews will be audio recorded if possible; if participants decline to be recorded, we will seek their permission to make written notes during the interviews.