Effectiveness of Remote Foot Temperature Monitoring

Diabetic Foot Clinical Trial

— STOP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05728411
• Other study ID #: IIR 21-176
• Status: Recruiting
• Phase: N/A
• Start date: October 2, 2023
• Est. completion date: December 31, 2031

Study information

• Verified date: October 2023
• Source: VA Office of Research and Development
• Contact: Rachel M Thomas
• Phone: (206) 277-4161
• Email: Rachel.Thomas3[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 31, 2031
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• Veteran

• Diabetes diagnosis

• Presence of foot ulcer up to 24 months prior (including active ulcer)

• Lower extremity amputation up to 24 months prior (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

Related Conditions & MeSH terms

• Diabetic Foot

Intervention

Other:
• Remote foot temperature monitoring system
Remote temperature monitoring involves a thermometric mat that can detect "hot spots" on the plantar surface of the foot. The mat has embedded cellular connectivity so that data can be transmitted from the patient's home to the company, where the temperature data can be analyzed. The company has a team of health coaches that work with patients and providers to detect signs of damage early in order to prevent ulceration.
• Enhanced usual care
Usual care is based on the VA's amputation prevention program (PAVE - Preventing Amputation in Veterans Everywhere - VHA Directive 1410), which provides a model of care for patients at risk for amputation as well as patients who have already undergone an amputation. Usual care will be enhanced by providing resources (e.g., information through written newsletters) relevant to a population of Veterans with diabetes, including information on nutrition and cooking, physical activities, and whole health opportunities

Locations

Country	Name	City	State
United States	Edward Hines Jr. VA Hospital, Hines, IL	Hines	Illinois
United States	Hunter Holmes McGuire VA Medical Center, Richmond, VA	Richmond	Virginia
United States	VA Puget Sound Health Care System Seattle Division, Seattle, WA	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Utilization (outpatient visits, emergency room visits, hospitalizations) - any vs. none and number	Based on electronic medical record data	6, 12, 18, and 24 months
Primary	Rate of foot ulceration	The primary outcome is the presence of new ulceration through 24 months	24 months
Secondary	Rate of lower limb amputation	Any level of lower extremity amputation	24 months
Secondary	Mean or median quality of life scores	Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health v1.2. The global scale produces two scores: Global Mental Health and Global Physical Health. Raw scores are converted to T-score values (higher values indicate better health). Minimum and maximum T scores for Global Mental Health are 21.2 and 67.6, respectively. Minimum and maximum T scores for Global Physical Health are 16.2 and 67.7, respectively.	6,12, 18 and 24 months
Secondary	Mean or median satisfaction with care scores	Short assessment of patient satisfaction (SAPS) by Hawthorne G et al (2006) which includes 7 items. Each item is scored on a 0 to 4 scale. The score range is from 0 (extremely dissatisfied) to 28 (extremely satisfied).	6,12, 18 and 24 months
Secondary	Mean or median self-efficacy for diabetes	8-item Self-efficacy for diabetes measure that has a range of 1 to 10. Higher scores indicate higher self-efficacy.	6, 12, 18, and 24 months