Clinical trial NCT05728411: Effectiveness of Remote Foot Temperature Monitoring
Official title: Home Foot-temperature Monitoring Through Smart Mat Technology to Improve Access, Equity, and Outcomes in High-risk Patients With Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetic Foot
Keywords: diabetic foot
Dept. of Veterans Affairs
remote sensing technology
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2023-02-15
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: Objective(s) and Hypotheses: Diabetic foot ulcers (DFU) 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. Remote temperature monitoring (RTM) of feet 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 measure foot temperatures 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 specific aims of this study are to: 1) Evaluate the effectiveness of RTM vs. usual care in terms of primary (ulceration) and secondary outcomes (severity of ulceration, amputation, hospitalization, emergency room visits, quality of life, satisfaction with care, and self-efficacy for managing diabetes) at 6, 12, 18, and 24 months; 2) Collect data on costs of RTM and compare with usual care costs, if effectiveness is demonstrated; and 3) Evaluate the implementation process, including barriers and facilitators to use among key stakeholders

Research Design: For Aim 1, the investigators will conduct a 3-site randomized controlled study. Aim 2 involves a budget impact analysis to evaluate costs of RTM. Aim 3 involves qualitative interviews to understand barriers and facilitators to implementation of RTM.

Methodology: For Aim 1, the investigators will aim to enroll at least 406 patients who have had a DFU or amputation within the past 24 months (including active ulcers). Patients will be randomized 1:1 to RTM or usual care (no RTM), with randomization stratified on site and active ulcer vs. not. For Aim 2, the investigators will collect data and observe providers to quantify provider time for selecting patients for RTM, ordering mats, and responding to alerts of "hot spots". The investigators will use medical records to assess patient utilization (ulcer/amputation-related outpatient, inpatient, and emergency room visits) and associated costs of care for patients in the RTM and comparison groups. For Aim 3, the investigators will conduct semi-structured phone interviews with 30-50 Veterans and 6-12 providers and use the Consolidated Framework for Implementation Research to guide data collection and analysis.

Relevance to VA Mission: Findings from this study will be used to inform effective, efficient, and equitable scaling of RTM in VA.

Eligibility criteria: Inclusion Criteria:

* Veteran
* Diabetes diagnosis
* History of foot ulcer (including active ulcer) OR history of lower extremity amputation (including unhealed amputation)
* Able to understand/read English

Exclusion Criteria:

* Dementia
* Unable to ambulate
* Bilateral lower extremity amputation
* Ankle brachial index \<0.6 or toe brachial index \<0.5
* Currently using in-home temperature monitoring
* Prisoner

Primary outcomes:
measure: Rate of foot ulceration
timeFrame: 24 months
Secondary outcomes:
measure: Rate of lower limb amputation
timeFrame: 24 months
measure: Mean or median quality of life scores
timeFrame: 6,12, 18 and 24 months
measure: Mean or median satisfaction with care scores
timeFrame: 6,12, 18 and 24 months
measure: Mean or median self-efficacy for diabetes
timeFrame: 6, 12, 18, and 24 months
Other outcomes:
measure: Utilization (outpatient visits, emergency room visits, hospitalizations) - any vs. none and number
timeFrame: 6, 12, 18, and 24 months
Locations:
city: Hines
country: United States
facility: Edward Hines Jr. VA Hospital, Hines, IL
state: Illinois
city: Richmond
country: United States
facility: Hunter Holmes McGuire VA Medical Center, Richmond, VA
state: Virginia
city: Seattle
country: United States
facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System Seattle Division, Seattle, WA
name: Alyson J. Littman, PhD MPH
role: PRINCIPAL_INVESTIGATOR
References: