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Table 1 Primary and secondary outcomes

From: Implementation of foot thermometry plus mHealth to prevent diabetic foot ulcers: study protocol for a randomized controlled trial

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