RECRUITING

Effectiveness of Remote Foot Temperature Monitoring

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Diabetic foot ulcers are common, debilitating, and costly complications of diabetes, disproportionately impacting Black and rural Veterans. Forty percent of individuals have an ulcer recurrence within a year of ulcer healing and 65% within 5 years. Monitoring plantar foot temperatures is one of the few interventions that reduces the risk of ulcer recurrence. Despite the evidence, adoption has been poor because the original procedures, including the use of handheld thermometers, were burdensome and time-consuming. Podimetrics, a private company, has developed a temperature monitoring system involving a "smart" mat that can wirelessly transmit data and a remote monitoring team that works with VA providers to assist with triage and monitoring. This care model has incredible promise, but has been untested in VA. The investigators propose to conduct a randomized trial to evaluate effectiveness of remote temperature monitoring as well as costs. Additionally, the investigators will evaluate the implementation process, including barriers and facilitators to use among key stakeholders.

Official Title

Home Foot-temperature Monitoring Through Smart Mat Technology to Improve Access, Equity, and Outcomes in High-risk Patients With Diabetes

Quick Facts

Study Start:2023-10-02
Study Completion:2031-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05728411

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Veteran
  2. * Diabetes diagnosis
  3. * History of foot ulcer (including active ulcer) OR history of lower extremity amputation (including unhealed amputation)
  4. * Able to understand/read English
  1. * Dementia
  2. * Unable to ambulate
  3. * Bilateral lower extremity amputation
  4. * Ankle brachial index \<0.6 or toe brachial index \<0.5
  5. * Currently using in-home temperature monitoring
  6. * Prisoner

Contacts and Locations

Study Contact

Rachel M Thomas
CONTACT
(206) 277-4161
Rachel.Thomas3@va.gov

Principal Investigator

Alyson J. Littman, PhD MPH
PRINCIPAL_INVESTIGATOR
VA Puget Sound Health Care System Seattle Division, Seattle, WA

Study Locations (Sites)

Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-3030
United States
Hunter Holmes McGuire VA Medical Center, Richmond, VA
Richmond, Virginia, 23249-0001
United States
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108-1532
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Alyson J. Littman, PhD MPH, PRINCIPAL_INVESTIGATOR, VA Puget Sound Health Care System Seattle Division, Seattle, WA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-02
Study Completion Date2031-12-31

Study Record Updates

Study Start Date2023-10-02
Study Completion Date2031-12-31

Terms related to this study

Keywords Provided by Researchers

  • diabetic foot
  • Dept. of Veterans Affairs
  • remote sensing technology

Additional Relevant MeSH Terms

  • Diabetic Foot