Standard Protocol Items: Recommendations for Interventional Trials schedule of enrolment, interventions and assessments.
Study period | ||||
Enrolment | Randomisation | Follow-up | Close-out | |
Timepoint | −1 | 0 | 3 months ±4 weeks | 9 months ±4 weeks |
Enrolment | ||||
Initial contact and study information | X | |||
Eligibility screen | X | |||
Informed consent | X | |||
Allocation | X | |||
Interventions | ||||
Group E-Rehab | ![]() | |||
‘My Knee UK’ Group | ![]() | |||
Control group (duration of treatment will be variable) | ![]() | |||
Assessments | ||||
Clinical information | ||||
Age, gender, ethnicity | X | |||
Previous joint surgery | X | |||
Employment and physical activity | X | |||
Height and weight | X | |||
History of current knee pain | X | |||
General health and medication use | X | X | X | |
Patient-reported outcomes | ||||
Joint pain manikin | X | X | X | |
Knee pain frequency (5-point scale) | X | X | X | |
Confidence and motivation to do exercises (11-point NRS) | X | X | X | |
Global change (7-point Likert scale) | X | X | ||
WOMAC (Pain, function and stiffness) | X | X | X | |
ASES | X | X | X | |
HADS | X | X | X | |
Generic health status (EQ-5D-5L) | X | X | X | |
Health-related quality of life (SF-12) | X | X | X | |
Resource use | X | X |
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.