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Table 1 Summary of measures

From: Clinical and cost effectiveness of computer treatment for aphasia post stroke (Big CACTUS): study protocol for a randomised controlled trial

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 12 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 12 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 12 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 12 months

Carer perception of change in communication

Carer COAST

Collected by blinded SLT at baseline. Separate blinded SLT at 6, 9, and 12 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.

  1. SLT = speech and language therapist; TOMS = Therapy Outcome Measures; COAST = Communication Outcomes After Stroke questionnaire; SLTA speech and language therapy assistant.