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Feasibility component
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Outcome measure
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Criterion for success
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Study results
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|---|
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Process
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Recruitment rate
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Number of Part. recruited
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2 part./month/site
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1.9 part./month/site
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Consent rate
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% part. consenting
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> 65% of part
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93%
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Retention rate
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% part. completing study
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> 85% complete T1
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93%
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Perceived satisfaction
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7-pt Likert scale
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> 85% report perceived benefits
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100%
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Resources
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Adherence rate
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Attend ≥ 10/12 intervention sessions
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> 85% of subjects
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100% attended 12 sessions
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Session length
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Evaluations < 2 h
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> 85% of evaluations
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100%
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Intervention burden
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Interventions < 1.15 h
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> 85% of sessions
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89.3%
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Management
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Participant processing time
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Time initial contact to enrolment
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Mean time < 10 days
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100%
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Treatment
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Safety (evaluation)
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Adverse events
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No adverse event
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No adverse event
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Safety (intervention)
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Adverse events
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No adverse event
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No adverse event
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