Statistical analysis plan for HOMESIDE: a randomised controlled trial for home-based family caregiver-delivered music and reading interventions for people living with dementia

Table 1 Schedule of enrolment, interventions and assessments

	Enrolment	Allocation	Intervention			Post-Intervention	Follow-up
Time point	*Day − 1*		*Day 1*	*Day 21*	*Day 42*	*Day 90*	*Day 180*
Enrolment:
Eligibility screen	X
Informed consent (or assent)	X
Dyad: allocation		X
Interventions:
*Music intervention training*			X	X	X
*Reading intervention training*			X	X	X
Assessments:
Person with dementia *sociodemographic information*	X
MMSE *(self)*	X					X
Dementia diagnosis *(proxy)*	X
NPI-Q *(proxy)*	X					X	X
MADRS *(proxy)*	X					X	X
QoL-AD *(self and proxy)*	X					X	X
EQ-5D-5L *(self and proxy)*	X					X	X
Adverse events; death, hospitalisation, death of CG			X	X	X	X	X
Caregiver *sociodemographic information*	X
PHQ-9	X					X	X
RS-14	X					X	X
SSCQ	X					X	X
QCPR	X					X	X
AQoL-6D	X					X	X
EQ-5D-5L *(self)*	X					X	X
RUD	X					X	X
Post-training questionnaires			X	X	X
Interviews						X
Diary (5 × weekly diary entries for MI and RI)			X	X	X	X
Adverse events: death, hospitalisation			X	X	X	X	X

Brackets denote who the measure represents (i.e. caregiver (CG), person with dementia (PwD) or dyad), although in some cases the CG provides a proxy measure for the PwD
The EQ-5D-5L and RUD are used in the cost-effectiveness analyses and their analyses are not detailed in the statistical analysis plan
MMSE Mini-Mental State Examination Score, NPI-Q Neuropsychiatric Inventory Questionnaire, MADRS Montgomery-Asberg Depression Rating Scale, QoL-AD Quality of Life-Alzheimer’s Disease, EQ-5D-5L The EuroQol instrument, PHQ-9 Patient Health Questionnaire, RS Resilience Scale, SSCQ Short Sense of Competence Questionnaire, QCPR Quality of Caregiver-Patient Relationship, AQoL-6D Assessment of Quality of Life-6D instrument, RUD Resource Utilisation in Dementia, MI Music intervention, RI Reading intervention

ISSN: 1745-6215