Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Intervention dosage throughout intervention |
Measured using the tailored diary for caregivers to record the duration of music or reading intervention use, responses of the person with dementia and details of activities used. |
Throughout the 12-weeks caregiver-delivered intervention (at least 5x per week) |
|
Other |
Caregivers' experiences of delivering the music and reading interventions |
Measured using post-intervention qualitative interviews with caregivers to capture descriptions of their experience of delivering the intervention and data to fine-tune the training, research design and the protocol. |
12-weeks (primary time point) |
|
Other |
Caregivers' experiences and reactions to the music and reading intervention training sessions |
Measured using a short questionnaire. |
Post intervention training sessions at 1-week, 3-weeks, and 6-weeks |
|
Other |
Caregivers' adherence to programme and ability to apply the learning from the training sessions in their day-to-day caring |
Measured using the tailored diary for caregivers to record the duration of music or reading intervention use, responses of the person with dementia and details of activities used |
Throughout the 12-weeks caregiver-delivered intervention (at least 5x per week) |
|
Other |
Change from baseline of cognition of participants with dementia at post-intervention to explore relationship between cognitive decline, behavioural and psychological symptoms of dementia, depression and response to different conditions |
Measured using the Mini-Mental State Examination (MMSE). Scores Higher scores indicate better cognitive capacity with scores of 24-30 indicating no cognitive impairment; 19-23 indicating mild cognitive impairment; 10-18 indicating moderate cognitive impairment; and scores <10 indicating severe cognitive impairment. |
baseline and 12-weeks (primary time-point, post-intervention) |
|
Other |
Adverse events |
Adverse events will be measured throughout the 12-week intervention period for all groups via fortnightly phone calls. Participants will be asked about any adverse events they may have experienced, including hospitalisations, unexpected GP appointments or negative responses to the interventions. |
Phone calls at weeks 2, 4, 6, 8, 10, 12 |
|
Primary |
Change from baseline of behavioural and psychological symptoms of participants with dementia at post-intervention and 6-month follow-up |
Measured by the Neuropsychiatric Inventory Questionnaire (NPI-Q). Severity scores range from 0-36, where higher scores indicate more severe behavioural and psychological symptoms of dementia. Distress scores range from 0-60, where higher values represent higher levels of distress due to symptoms. |
baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up) |
|
Secondary |
Change from baseline of depression in participants with dementia at post-intervention and 6-month follow-up |
Measured by the Montgomery Asberg Depression Rating Scale (MADRS). Scale scores range from 0-60, where higher scores indicate more severe depression. |
baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up) |
|
Secondary |
Change from baseline of quality of life of participants with dementia at post-intervention and 6-month follow-up |
Measured by the Quality of Life - Alzheimer's Disease (QoL-AD) scale. Scale scores range from 13-52, where higher scores indicate higher quality of life. |
baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up) |
|
Secondary |
Change from baseline of depression in caregiver participants at post-intervention and 6-month follow-up |
Measured by the Patient Health Questionnaire-9 (PHQ-9). Scale scores range from 0-27, where scores greater than 20 indicate severe depression. |
baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up) |
|
Secondary |
Change from baseline of resilience in caregiver participants at post-intervention and 6-month follow-up |
Measured by the Resilience Scale-14 (RS-14). Scale scores range from 14-98, where higher scores indicate higher resilience. |
baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up) |
|
Secondary |
Change from baseline in caregiver competence of caregiver participants at post-intervention and 6-month follow-up |
Measured by the Short Sense of Competence Questionnaire (SSCQ). Scale scores range from 7-35, where higher scores indicate higher sense of competence. |
baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up) |
|
Secondary |
Change from baseline in quality of life of caregiver participants at post-intervention and 6-month follow-up |
Measured by the Assessment of Quality of Life-6D (AQOL-6D). |
baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up) |
|
Secondary |
Change from baseline in quality of the relationship between caregiver and person with dementia at post-intervention and 6-month follow-up |
Measured by the Quality of Caregiver-Patient Relationship (QCPR). Scale scores range from 14-70, where higher scores indicate a higher quality of relationship. |
baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up) |
|
Secondary |
Change from baseline in quality of adjusted life-years of caregiver and person with dementia at post-intervention and 6-month follow-up |
Measured by the EuroQoL Instrument (EQ-5D-5L). |
baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up) |
|
Secondary |
Change from baseline in resource use of both caregiver and person with dementia (cost-effectiveness) at post-intervention and 6-month follow-up |
Measured by the Resource Utilization in Dementia (RUD). |
baseline, 12-weeks (primary time-point), and 6-months after intervention commencement (follow-up) |
|