Home Foot-temperature Monitoring Through Smart Mat Technology to Improve Access, Equity, and Outcomes in High-risk Patients With Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 379
- 试验地点
- 8
- 主要终点
- Rate of foot ulceration
研究概览
简要总结
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.
详细描述
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 multi-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 history of DFU or amputation (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 12-30 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes diagnosis
- •History of foot ulcer (including active ulcer) OR history of lower extremity amputation (including unhealed amputation)
- •Able to understand/read English
排除标准
- •Unable to ambulate
- •Bilateral lower extremity amputation
- •Ankle brachial index <0.6 or toe brachial index <0.5
- •Currently using in-home temperature monitoring
研究组 & 干预措施
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
干预措施: Enhanced usual care (Other)
Remote temperature monitoring + enhanced usual care
Enrollment in remote foot temperature monitoring in addition to enhanced usual care (described below)
干预措施: Remote foot temperature monitoring system (Other)
Remote temperature monitoring + enhanced usual care
Enrollment in remote foot temperature monitoring in addition to enhanced usual care (described below)
干预措施: Enhanced usual care (Other)
结局指标
主要结局
Rate of foot ulceration
时间窗: 24 months
The primary outcome is the presence of new ulceration through 24 months
次要结局
- Mean or median satisfaction with care scores(6,12, 18 and 24 months)
- Rate of lower limb amputation(24 months)
- Mean or median self-efficacy for diabetes(6, 12, 18, and 24 months)
- Mean or median quality of life scores(6,12, 18 and 24 months)