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Trial record 42 of 661 for:    SMS

Implementation of Foot Thermometry and SMS and Voice Messaging to Prevent Diabetic Foot Ulcer

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ClinicalTrials.gov Identifier: NCT02373592
Recruitment Status : Completed
First Posted : February 27, 2015
Last Update Posted : December 15, 2017
Sponsor:
Collaborators:
Johns Hopkins University
Mayo Clinic
University of Southern California
Information provided by (Responsible Party):
Jaime Miranda, Universidad Peruana Cayetano Heredia

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.


Condition or disease Intervention/treatment Phase
Diabetic Foot Behavioral: SMS and voice messaging Device: Thermometry Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Implementation of Foot Thermometry and SMS and Voice Messaging to Prevent Diabetic Foot Ulcer
Actual Study Start Date : September 2015
Actual Primary Completion Date : September 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Thermometry-only group

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)

Device: Thermometry
Subjects will be provided with a TempStat (foot thermometer), a device that captures a thermal image of feet. (See Detailed description)

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 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).

Behavioral: 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 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).


Device: Thermometry
Subjects will be provided with a TempStat (foot thermometer), a device that captures a thermal image of feet. (See Detailed description)




Primary Outcome Measures :
  1. Foot ulceration [ Time Frame: 18 months ]

    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.



Secondary Outcome Measures :
  1. Adherence to daily temperature measurement [ Time Frame: 18 months ]
    Adherence to temperature measurements will be based on patient self-report of foot temperature monitoring through recording in patient's logbooks.

  2. Report of an alarm sign to the nurse [ Time Frame: 18 months ]
    Compare the frequency of alarms signs reported to the study nurse

  3. Report of an alarm sign in the logbook [ Time Frame: 18 months ]
    Compare the frequency of alarms signs reported in the patient's logbooks.

  4. Dose-response analysis of SMS and voice messaging [ Time Frame: 18 months ]
    Dose-response per protocol analysis will be performed.

  5. Glycosilated hemoglobin control targets [ Time Frame: 18 months ]
    Reduce of 1% or more of glycosylated hemoglobin.


Other Outcome Measures:
  1. Sub-group analyses, all participants [ Time Frame: 18 months ]

    The primary outcome will be subjected to pre-specified heterogeneity in treatment effects. In the following analyses, variables will be considered positive if its presence/usage is reported at baseline and in at the last evaluation of the participant during study period.

    1. Caregiving status, assistance provided to the patient with i) basic activities of daily living, or ii) in the identification, prevention, or treatment of diabetes or any disability.
    2. Use of insoles and/or orthopedic shoes.

  2. Sub-group analyses, intervention group only [ Time Frame: 18 months ]
    1)In order to receive the SMS and voice messaging, the intervention requires ownership of a cell phone by either the patient or its caregiver. This sub-group analysis will explore the primary outcome by the type of recipient (patient vs caregivers) of the messaging intervention.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373592


Locations
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Peru
Hospital Cayetano Heredia
Lima, Peru, Lima 31
Hospital Nacional Arzobispo Loayza
Lima, Peru, Lima 5
Sponsors and Collaborators
Universidad Peruana Cayetano Heredia
Johns Hopkins University
Mayo Clinic
University of Southern California
Investigators
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Principal Investigator: Jaime Miranda, MD, PhD Universidad Peruana Cayetano Heredia

Additional Information:
Publications:
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Responsible Party: Jaime Miranda, PhD, Universidad Peruana Cayetano Heredia
ClinicalTrials.gov Identifier: NCT02373592     History of Changes
Other Study ID Numbers: 1R21TW009982 ( U.S. NIH Grant/Contract )
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: August 2017
Keywords provided by Jaime Miranda, Universidad Peruana Cayetano Heredia:
Diabetic Neuropathies
Thermometry
Diabetes Mellitus, Type 2
Foot Ulcer
Telemedicine
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases