Implementation of Foot Thermometry and SMS and Voice Messaging to Prevent Diabetic Foot Ulcer
1 other identifier
interventional
172
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2015
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2015
CompletedFirst Posted
Study publicly available on registry
February 27, 2015
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedDecember 15, 2017
August 1, 2017
2 years
February 20, 2015
December 13, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Foot ulceration
The primary outcome is foot ulceration occurring at any point during the 12 month study duration. Foot ulceration will be defined using the American Diabetes Association criteria, which defines ulcers as any break in the cutaneous barrier; that usually extend through the full thickness of the dermis. There will be two ways of identifying if a patient has developed foot ulceration: (1) during the clinical evaluations done by a nurse every 2 months. (2) In addition to these bimonthly assessments, patients will be advised to make telephone calls to the study's nurse to report the presence of an ulcer, and he/she will be asked to go to the hospital for a face-to-face evaluation to be conducted by a masked nurse.
18 months
Secondary Outcomes (5)
Adherence to daily temperature measurement
18 months
Report of an alarm sign to the nurse
18 months
Report of an alarm sign in the logbook
18 months
Dose-response analysis of SMS and voice messaging
18 months
Glycosilated hemoglobin control targets
18 months
Other Outcomes (2)
Sub-group analyses, all participants
18 months
Sub-group analyses, intervention group only
18 months
Study Arms (2)
Thermometry-only group
PLACEBO COMPARATORSubjects 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 plus SMS and voice messaging
EXPERIMENTALThermometry-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 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).
Interventions
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)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Current ulcers or open amputation sites.
- Active osteoarthropathy
- Severe peripheral vascular disease
- Foot infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universidad Peruana Cayetano Heredialead
- Johns Hopkins Universitycollaborator
- Mayo Cliniccollaborator
- University of Southern Californiacollaborator
Study Sites (2)
Hospital Cayetano Heredia
Lima, Lima 31, Peru
Hospital Nacional Arzobispo Loayza
Lima, Lima 5, Peru
Related Publications (2)
Lazo-Porras M, Bernabe-Ortiz A, Sacksteder KA, Gilman RH, Malaga G, Armstrong DG, Miranda JJ. Implementation of foot thermometry plus mHealth to prevent diabetic foot ulcers: study protocol for a randomized controlled trial. Trials. 2016 Apr 19;17(1):206. doi: 10.1186/s13063-016-1333-1.
PMID: 27094007BACKGROUNDLazo-Porras M, Bernabe-Ortiz A, Taype-Rondan A, Gilman RH, Malaga G, Manrique H, Neyra L, Calderon J, Pinto M, Armstrong DG, Montori VM, Miranda JJ. Foot thermometry with mHeath-based supplementation to prevent diabetic foot ulcers: A randomized controlled trial. Wellcome Open Res. 2020 Aug 28;5:23. doi: 10.12688/wellcomeopenres.15531.2. eCollection 2020.
PMID: 32923686DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jaime Miranda, MD, PhD
Universidad Peruana Cayetano Heredia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
February 20, 2015
First Posted
February 27, 2015
Study Start
September 1, 2015
Primary Completion
September 1, 2017
Study Completion
October 1, 2017
Last Updated
December 15, 2017
Record last verified: 2017-08