Outcome | Measure | Method of collection |
---|---|---|
Change in word finding ability | Naming of 100 personally relevant words | Taken at baseline by blinded SLT recruiting participant 6, 9 and 12Â months by separate blinded SLT. |
Change in functional communication | 10-minute videoed conversations structured around topics of personal interest. Activity scale of TOMS used to measure conversational ability | Conversations at baseline by blinded SLT. Separate blinded SLT follows same topic guide at 6, 9 and 12Â months. Videos randomised and rated centrally by blinded assessors. |
Change in patient perception of communication and quality of life | COAST self-reported questionnaire. | Administered by blinded SLT at baseline. Separate blinded SLT at 6, 9, and 12Â months. |
Generalisation to untreated words | Naming Objects subtest from Comprehensive Aphasia Test | As above |
QALYs for cost effectiveness | EQ-5D for patient and carer (accessible and by proxy) | As above |
Carer quality of life | Carer COAST and CarerQol | Self-administered |
Cost of intervention | Diaries of time spent on intervention | Self-administered by SLTs, SLTAs and volunteers |
Cost of usual care | Diaries of time spent on usual care | SLT collects data from usual treating therapists and participants at baseline, 3, 6, 9 and 12Â months |
Carer perception of change in communication | Carer COAST | Collected by blinded SLT at baseline. Separate blinded SLT at 6, 9, and 12Â months. |
Negative effects of treatment | Patient diary to record any difficulties and/or negative impacts of intervention | Patients and carers - central team to send monthly letter reminding to send back in prepaid envelope. |
Intervention adherence | Software tailoring checklists. Volunteer and/or assistant feedback forms. Software key files. Puzzle book and telephone support feedback. | Completed by SLT, monitored by central study team. Self-managed practice monitored by central study team. Puzzle book completion and telephone support recorded by member of central study team. |