78 Chapter 4 Table 2 Continued. STUDY PERIOD Enrolment Allocation Post-allocation Close-out TIMEPOINT 0m 0m 3m 6m 9m 12m 15m 18m 21m 24m Secondary outcome measures Pain intensity (11-point NRS) X X X X Physical activity (Activ8) X X X X Patient self-reported Adherence to prescribed exercises (EARS) X X X PT assessed adherence to prescribed exercises (EXAS) Adherence to the smartphone application (backend application) Fear avoidance beliefs (FABQ) X X X X Pain catastrophizing (PCS) X X X X Self-efficacy (GSE Scale) X X X X Patient activation (PAM 13-Dutch) X X X X Number of recurrent LBP episodes (Questionnaire) X X X Economic evaluation Health related quality of life (EQ-5D-5L) X X X X LBP related costs (Cost questionnaire) X X X X X X X X X Other measures Content and number of PT sessions (Registration form) Indicator for a period; duration of the period is not limited to length of the indicator and dependent on duration of interventions and use of smartphone application LBP = low back pain, BMI = Body Mass Index, ODI = Oswestry Disability Index, NRS = Numeric Rating Scale, EARS = Exercise Adherence Rating Scale, PT = Physiotherapist, EXAS = Exercise Adherence Scale, FABQ = Fear-Avoidance Beliefs Questionnaire, PCS = Pain Catastrophizing Scale, GSE scale = General Self-efficacy Scale, PAM = Patient Activation Measure, EQ-5D-5L = EuroQol 5D Sample size calculation
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