Table 3 Study timeline
Before enrolment | Enrolment | Baseline | Visit 1 | Visit 2 | Visit 3 | Visit 4 close-out | |
|---|---|---|---|---|---|---|---|
Timepoint | -t 1 | 0 | 3 months | 6 months | 9 months | 12 months | |
Screening | X | ||||||
GIS mapping | X | ||||||
Potential willingness to participate | X | ||||||
Inclusion and exclusion criteria | X | X | |||||
Consent | X | ||||||
Randomisation | X | ||||||
Socio-demographic | X | X | |||||
Economic | X | X | X | X | |||
ADLA (recall) | X | X | |||||
ADLA diary | X | X | X | X | |||
SAEs | X | X | X | X | X | ||
DLQI | X | X | X | X | X | ||
WHO-DAS II | X | X | X | ||||
Stigma scale | X | X | X | ||||
Clinical stage | X | X | X | X | X | ||
Mossy lesions | X | X | X | ||||
Foot and leg Circumference | X | X | X | ||||
Interdigital lesions | X | X | X | ||||
Foot care and hygiene intervention (immediate treatment group)* |
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