Outcomes | Source of data | |
---|---|---|
measure | End-point | |
Ulceration | Clinical evaluation by a trained nurse Participant’s report | Every 2 months until 12 months Any time during the 12 months |
Adherence to daily temperature measurement | Logbook | Every 2 months until 12 months |
Report of an alarm sign to the nurse | Nurse report | Every 2 months until 12 months |
Report of an alarm sign in the logbook | Logbook | Every 2 months until 12 months |
Dose-response analysis of SMS and voice messages | Automated system | Every 2 months until 12 months |
Glycated hemoglobin | Blood sample | At 6 and 12 months |
Sub-group analyses, in all participants | ||
Caregiving status | Participant’s report | Every 2 months until 12 months |
Use of insoles and/or orthopedic shoes | Participant’s report | Every 2 months until 12 months |
Sub-group analyses, intervention arm only | ||
Type of recipient (patient versus caregivers) | Participant’s report | Every 2 months until 12 months |