Implementation of Foot Thermometry and SMS and Voice Messaging to Prevent Diabetic Foot Ulcer
Condition: Diabetic Foot
MeSH terms: Diabetic Foot; Foot Ulcer
Study type: Interventional

Summary: 
      This study aims to implement daily temperature measurements of feet complemented by SMS and
      voice messaging to prevent diabetic foot ulcers in patients with type 2 diabetes mellitus at
      high risk of ulceration.

      Design: Physician-blinded, randomized, 18-month trial.

      Setting: Diabetes outpatient clinics from two public hospitals

      Population: Subjects will be eligible if they (1) have a diagnosis of type 2 diabetes
      mellitus, (2) are between 18 - 80 years of age, (3) have a present dorsalis pedis pulse in
      both feet, (4) are in risk group 2 or 3 using the diabetic foot risk classification system as
      specified by the International Working Group on the Diabetic Foot, (5) have an operating cell
      phone or a caregiver with an operating cell phone, and (6) have the ability to provide
      informed consent.

      Hypothesis: The investigators hypothesize that implementation of an enhanced intervention
      that combines daily temperature measurement for the reduction of diabetic foot ulcer with SMS
      and voice messaging will improve patient measurement compliance and reduce diabetic foot
      ulcers in a middle income country.
    

Detailed description: 
      Detailed Description:

      Thermometry is a promising emerging modality for the prevention of diabetic foot ulcers
      according to different clinical trials. However, patient compliance with self-monitoring
      temperature at home is a concern, as they may be forgetful or find it difficult to get into a
      consistent routine of daily monitoring. Therefore, the investigators propose to determine the
      utility of SMS and voice messaging to remind the patients to perform the thermometry, and to
      assess the impact on diabetic foot ulceration.

      Specific Aims are:

        1. Compare the incidence of diabetic foot ulceration during the study between the arm that
           receives thermometry alone and the arm that receives thermometry plus SMS and voice
           messaging.

        2. Compare the compliance with foot thermometer use between the two study arms.

        3. Compare the frequency of alarms signs reported to the study nurse in the two study arms.

        4. Compare the frequency of alarms signs reported in the patient's logbooks in the two
           study arms.

        5. Compare the incidence of diabetic foot ulceration according to pre-specified sub-groups:
           caregiving status, and use of insoles and/or orthopedic shoes.

        6. In the intervention-only group, compare the incidence of diabetic foot ulcers by varying
           the recipient of the messaging intervention (patient vs caregivers).

      Intervention:

        1. Placebo Comparator: Thermometry-only group. Subjects will be provided with a TempStat
           (foot thermometer), a device that captures a thermal image of feet through colors.

           Some alarm signs have been pre-specified: 1) When the thermal image shows yellow spots
           in any area of any feet for two consecutive days, 2) when the thermal image shows
           different colors in contralateral areas of the feet for two consecutive days or, 3) a
           dermal lesion is detected at any time. In any of these three scenarios, subjects will be
           instructed to contact the study nurse by phone or text message.

           For the first two types of alarm signs, once the study nurse is contacted he/ she will
           ask about the presence of lesions in the patient's feet and the patient's activity on
           the previous two weeks, and will provide recommendations on how to decrease activity
           until temperatures normalize. If TempStat measurements continue to show alarm signs for
           more than one week after the telephone consultation, the participant will be asked to
           contact the nurse and schedule a face-to-face evaluation to assess the presence of an
           infection and/or ulcer with a masked assessor.

           In the third type of alarm sign, presence of a dermal lesion, participants will be asked
           to contact the study's nurse and he/she will make an appointment for an evaluation with
           a nurse blind to the intervention.

           When the main outcome, foot ulceration, has been confirmed, patients will be directed by
           the study nurse to receive professional care by a specialist.

        2. Experimental: Thermometry plus SMS and voice messaging Thermometry-related intervention
           activities will be the same as those established for the thermometry-only group. In
           addition, this group will receive reminders to use the TempStat (two messages) and
           promote foot care (six messages). The content of these eight messages has been developed
           and validated through both via SMS and voice messaging. During the first two weeks of
           the intervention, only reminders to use the TempStat will be sent, daily, Monday to
           Friday, both SMS and voice messaging. Hereafter, for the remaining 76 weeks, patients
           will only receive two messages per week, one SMS and one voice message, alternating
           content (reminders to use TempStat and promotion of foot care).
    

Intervention name(s): SMS and voice messaging; Thermometry
Intervention type(s): Behavioral; Device
Intervention description(s): This group will receive reminders to use the TempStat (two messages) and promote foot care (six messages). The content of these eight messages have been developed and validated their delivery through both, SMS and voice messaging.
During the first two weeks of the intervention, only reminders to use the TempStat will be sent, daily, Monday to Friday, both via SMS and voice messaging.
Hereafter, for the remaining 76 weeks, patients will only receive two messages per week, one SMS and one voice message, alternating content (reminders to use TempStat and promotion of foot care).; Subjects will be provided with a TempStat (foot thermometer), a device that captures a thermal image of feet. (See Detailed description)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Diabetic Neuropathies; Thermometry; Diabetes Mellitus, Type 2; Foot Ulcer; Telemedicine