Overview

This trial is active, not recruiting.

Condition diabetic foot
Treatments sms and voice messaging, thermometry
Sponsor Universidad Peruana Cayetano Heredia
Collaborator Johns Hopkins University
Start date September 2015
End date January 2017
Trial size 172 participants
Trial identifier NCT02373592, 1R21TW009982

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, 12-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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(Placebo Comparator)
Subjects will be provided with a TempStat (foot thermometer), a device that captures a thermal image of feet. Some alarm signs have been pre-specified: 1) thermal image shows yellow spots in any area of feet for two consecutive days, 2) thermal image shows different colors in contralateral areas of the feet for two consecutive days or, 3) a dermal lesion. In any of these three scenarios, subjects will be instructed to contact the study nurse by phone. (See Detailed Description for more detail on the actions after an alarm sign has been observed)
thermometry
Subjects will be provided with a TempStat (foot thermometer), a device that captures a thermal image of feet. (See Detailed description)
(Experimental)
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 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 50 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).
sms and voice messaging
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 50 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).
thermometry
Subjects will be provided with a TempStat (foot thermometer), a device that captures a thermal image of feet. (See Detailed description)

Primary Outcomes

Measure
Foot ulceration
time frame: 12 months

Secondary Outcomes

Measure
Adherence to daily temperature measurement
time frame: 12 months
Report of an alarm sign to the nurse
time frame: 12 months
Report of an alarm sign in the logbook
time frame: 12 months
Dose-response analysis of SMS and voice messaging
time frame: 12 months
Glycosilated hemoglobin control targets
time frame: 12 months

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - Diagnosis of type 2 diabetes mellitus. - Dorsalis pedis pulse in both feet. - In risk group 2 or 3 using the diabetic foot risk classification system as specified by the International Working Group on the Diabetic Foot. - Operating cell phone or a caregiver with an operating cell phone. - Ability to provide informed consent. Exclusion Criteria: - Current ulcers or open amputation sites. - Active osteoarthropathy - Severe peripheral vascular disease - Foot infection

Additional Information

Official title Implementation of Foot Thermometry and SMS and Voice Messaging to Prevent Diabetic Foot Ulcer
Principal investigator J Jaime Miranda, PhD
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 50 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).
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Universidad Peruana Cayetano Heredia.