Study period | |||||||
---|---|---|---|---|---|---|---|
Time points | Enrollment | Allocation | Post allocation | Close-out | |||
Baseline | Baseline | Baseline | Week 4 | Week 8 | Week 26 | Week 26 | |
Enrollment: | Â | Â | Â | Â | Â | Â | Â |
Eligibility screen | X | Â | Â | Â | Â | Â | Â |
Informed consent | X | Â | Â | Â | Â | Â | Â |
Allocation | Â | X | Â | Â | Â | Â | Â |
Intervention arm: | Â | Â | Â | Â | Â | Â | Â |
App | Â | Â | Â | Â | Â | Â | Â |
Cal/BD | Â | Â | Â | Â | Â | Â | Â |
Non-intervention arm: | Â | Â | Â | Â | Â | Â | Â |
Cal/BD | Â | Â | Â | Â | Â | Â | Â |
Assessments: | Â | Â | Â | Â | Â | Â | Â |
Socio-demographics | Â | Â | X | Â | Â | Â | Â |
Adverse events | Â | Â | X | X | X | X | Â |
Primary outcomes | Â | Â | Â | Â | Â | Â | Â |
Rates of adherence: | Â | Â | Â | X | Â | Â | Â |
 Patient report |  |  |  |  |  |  |  |
 Weight of foam canisters |  |  |  |  |  |  |  |
 No. treatment sessions |  |  |  |  |  |  |  |
Secondary outcomes | Â | Â | Â | Â | Â | Â | Â |
LS-PGA | Â | Â | X | X | X | X | Â |
DLQI | Â | Â | X | X | X | X | Â |