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

Lazo-Porras M, Bernabe-Ortiz A, Sacksteder KA, Gilman RH, Malaga G, Armstrong DG, Miranda JJ - Trials (2016)

Bottom Line: This study has two principal contributions towards the prevention of DFU.First, the introduction of messages to promote self-management of diabetes foot care as well as using reminders as a strategy to improve adherence to daily home-based measurements.Secondly, the implementation of a thermometry-based strategy complemented by SMS and voice messages in an LMIC setting, with wider implications for scalability.

View Article: PubMed Central - PubMed

Affiliation: CRONICAS Center of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Av. Armendáriz 497, Miraflores, Lima 18, Peru.

ABSTRACT

Background: Diabetic foot neuropathy (DFN) is one of the most important complications of diabetes mellitus; its early diagnosis and intervention can prevent foot ulcers and the need for amputation. Thermometry, measuring the temperature of the feet, is a promising emerging modality for diabetic foot ulcer prevention. However, patient compliance with at-home monitoring is concerning. Delivering messages to remind patients to perform thermometry and foot care might be helpful to guarantee regular foot monitoring. This trial was designed to compare the incidence of diabetic foot ulcers (DFUs) between participants who receive thermometry alone and those who receive thermometry as well as mHealth (SMS and voice messaging) over a year-long study period.

Methods/design: This is an evaluator-blinded, randomized, 12-month trial. Individuals with a diagnosis of type 2 diabetes mellitus, aged between 18-80 years, having a present dorsalis pedis pulse in both feet, 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), have an operating cell phone or a caregiver with an operating cell phone, and have the ability to provide informed consent will be eligible to participate in the study. Recruitment will be performed in diabetes outpatient clinics at two Ministry of Health tertiary hospitals in Lima, Peru.

Interventions: participants in both groups will receive education about foot care at the beginning of the study and they will be provided with a thermometry device (TempStat™). TempStat™ is a tool that captures a thermal image of the feet, which, depending on the temperature of the feet, shows different colors. In this study, if a participant notes a single yellow image or variance between one foot and the contralateral foot, they will be prompted to notify a nurse to evaluate their activity within the previous 2 weeks and make appropriate recommendations. In addition to thermometry, participants in the intervention arm will receive an mHealth component in the form of SMS and voice messages as reminders to use the thermometry device, and instructions to promote foot care.

Outcomes: the primary outcome is foot ulceration, evaluated by a trained nurse, occurring at any point during the study.

Discussion: This study has two principal contributions towards the prevention of DFU. First, the introduction of messages to promote self-management of diabetes foot care as well as using reminders as a strategy to improve adherence to daily home-based measurements. Secondly, the implementation of a thermometry-based strategy complemented by SMS and voice messages in an LMIC setting, with wider implications for scalability.

Trial registration: This study is registered in ClinicalTrials.gov: Identifier NCT02373592 .

No MeSH data available.


Related in: MedlinePlus

Process of screening evaluation. Legend: description of the inclusion and exclusion criteria of the study and screening process. IWGDF: International Working Group on the Diabetic Foot
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License 1 - License 2
getmorefigures.php?uid=PMC4837616&req=5

Fig1: Process of screening evaluation. Legend: description of the inclusion and exclusion criteria of the study and screening process. IWGDF: International Working Group on the Diabetic Foot

Mentions: Recruitment will be performed in the outpatient clinics of the aforementioned hospitals. Subjects will be eligible if they have a diagnosis of T2DM, are between 18 and 80 years of age, 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) [19–21], have a present dorsalis pedis pulse in both feet, have an operating cell phone or a caregiver with an operating cell phone, and have the ability to provide informed consent. Subjects will not be eligible for enrollment if they have current foot ulcers, active Charcot osteoarthropathy, severe peripheral arterial disease, or foot infection (Fig. 1).Fig. 1


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

Lazo-Porras M, Bernabe-Ortiz A, Sacksteder KA, Gilman RH, Malaga G, Armstrong DG, Miranda JJ - Trials (2016)

Process of screening evaluation. Legend: description of the inclusion and exclusion criteria of the study and screening process. IWGDF: International Working Group on the Diabetic Foot
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4837616&req=5

Fig1: Process of screening evaluation. Legend: description of the inclusion and exclusion criteria of the study and screening process. IWGDF: International Working Group on the Diabetic Foot
Mentions: Recruitment will be performed in the outpatient clinics of the aforementioned hospitals. Subjects will be eligible if they have a diagnosis of T2DM, are between 18 and 80 years of age, 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) [19–21], have a present dorsalis pedis pulse in both feet, have an operating cell phone or a caregiver with an operating cell phone, and have the ability to provide informed consent. Subjects will not be eligible for enrollment if they have current foot ulcers, active Charcot osteoarthropathy, severe peripheral arterial disease, or foot infection (Fig. 1).Fig. 1

Bottom Line: This study has two principal contributions towards the prevention of DFU.First, the introduction of messages to promote self-management of diabetes foot care as well as using reminders as a strategy to improve adherence to daily home-based measurements.Secondly, the implementation of a thermometry-based strategy complemented by SMS and voice messages in an LMIC setting, with wider implications for scalability.

View Article: PubMed Central - PubMed

Affiliation: CRONICAS Center of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Av. Armendáriz 497, Miraflores, Lima 18, Peru.

ABSTRACT

Background: Diabetic foot neuropathy (DFN) is one of the most important complications of diabetes mellitus; its early diagnosis and intervention can prevent foot ulcers and the need for amputation. Thermometry, measuring the temperature of the feet, is a promising emerging modality for diabetic foot ulcer prevention. However, patient compliance with at-home monitoring is concerning. Delivering messages to remind patients to perform thermometry and foot care might be helpful to guarantee regular foot monitoring. This trial was designed to compare the incidence of diabetic foot ulcers (DFUs) between participants who receive thermometry alone and those who receive thermometry as well as mHealth (SMS and voice messaging) over a year-long study period.

Methods/design: This is an evaluator-blinded, randomized, 12-month trial. Individuals with a diagnosis of type 2 diabetes mellitus, aged between 18-80 years, having a present dorsalis pedis pulse in both feet, 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), have an operating cell phone or a caregiver with an operating cell phone, and have the ability to provide informed consent will be eligible to participate in the study. Recruitment will be performed in diabetes outpatient clinics at two Ministry of Health tertiary hospitals in Lima, Peru.

Interventions: participants in both groups will receive education about foot care at the beginning of the study and they will be provided with a thermometry device (TempStat™). TempStat™ is a tool that captures a thermal image of the feet, which, depending on the temperature of the feet, shows different colors. In this study, if a participant notes a single yellow image or variance between one foot and the contralateral foot, they will be prompted to notify a nurse to evaluate their activity within the previous 2 weeks and make appropriate recommendations. In addition to thermometry, participants in the intervention arm will receive an mHealth component in the form of SMS and voice messages as reminders to use the thermometry device, and instructions to promote foot care.

Outcomes: the primary outcome is foot ulceration, evaluated by a trained nurse, occurring at any point during the study.

Discussion: This study has two principal contributions towards the prevention of DFU. First, the introduction of messages to promote self-management of diabetes foot care as well as using reminders as a strategy to improve adherence to daily home-based measurements. Secondly, the implementation of a thermometry-based strategy complemented by SMS and voice messages in an LMIC setting, with wider implications for scalability.

Trial registration: This study is registered in ClinicalTrials.gov: Identifier NCT02373592 .

No MeSH data available.


Related in: MedlinePlus