Table 4

Standard Protocol Items: Recommendations for Interventional Trials schedule of enrolment, interventions and assessments.

Study period
EnrolmentRandomisationFollow-upClose-out
Timepoint−103 months
±4 weeks
9 months
±4 weeks
Enrolment
Initial contact and study informationX
Eligibility screenX
Informed consentX
AllocationX
Interventions
Group E-RehabGraphic
‘My Knee UK’ GroupGraphic
Control group (duration of treatment will be variable)Graphic
Assessments
Clinical information
Age, gender, ethnicityX
Previous joint surgeryX
Employment and physical activityX
Height and weightX
History of current knee painX
General health and medication useXXX
Patient-reported outcomes
Joint pain manikinXXX
Knee pain frequency
(5-point scale)
XXX
Confidence and motivation to do exercises (11-point NRS)XXX
Global change
(7-point Likert scale)
XX
WOMAC
(Pain, function and stiffness)
XXX
ASESXXX
HADSXXX
Generic health status
(EQ-5D-5L)
XXX
Health-related quality of life
(SF-12)
XXX
Resource useXX
  • ASES, Arthritis Self-Efficacy Scale; EQ-5D-5L, European Quality of Life-Five Dimension-Five Level Scale; HADS, Hospital Anxiety and Depression Scale; NRS, numeric rating scale; SF-12, 12-Item Short Form Survey; WOMAC, The Western Ontario and McMaster Universities Osteoarthritis Index.