Study period | |||||||
---|---|---|---|---|---|---|---|
Enrolment | Baseline assessment | Allocation | Post-allocation assessments | ||||
Timepoint | T -1 | T 0 | T 1 | T 2 | T 3 | T 4 | |
Enrolment: | |||||||
Informed consent | X | ||||||
Eligibility screening | X | ||||||
Baseline assessment | X | ||||||
Randomization | X | ||||||
Intervention: | |||||||
E-nergEYEze | X | X | X | X | X | ||
Care as usual | X | X | X | X | X | ||
Assessments: | |||||||
General questionnaire | X | ||||||
Primary outcome | X | X | X | ||||
Secundary outcomes | |||||||
- Clinical effectiveness | X | X | X | X | Xa | ||
- Cost effectiveness | Xb | X | Xb | X | Xb | ||
Process evaluation | X | Xc | |||||
Working mechanism | X | X | X |