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临床试验/NCT03506776
NCT03506776已完成不适用

Foot Intervention Study Utilizing Commercially Available Infrared Thermometers With Individuals With Diabetes Using a Mixed Methods Approach

Memorial University of Newfoundland2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2017年8月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
62
试验地点
2
主要终点
change from baseline foot assessment as evidenced by a diabetic foot ulcer

研究概览

简要总结

Foot self-management is important in preventing diabetic foot ulcers. However, even when individuals care for their feet, the signs of inflammation are often missed. A tool that will identify inflammation, a sign of initial tissue damage, may be needed. Previous research has shown that foot temperature self-monitoring reduced ulcer incidence by providing a warning sign of inflammation. However, these studies used an expensive medical thermometer. The objectives for this mixed-methods study are: (1) to determine if a foot health intervention that utilizes an inexpensive commercially-available infrared thermometer (CAIT) improves foot outcomes for individuals with diabetes; (2) to identify factors impacting foot self-management; (3) and to explore the participants', family and support persons', and healthcare providers' experiences with foot self-management and the intervention. This study will have three phases: Phase 1, patients, family and support person, and healthcare providers will share their insights regarding foot self-management to inform the intervention; Phase 2, a six-month RCT will assess the effectiveness of a CAIT; Phase 3, interviews will be conducted with participants, family and support persons, and health providers to explore their experiences with the intervention.

详细描述

Diabetes is a global health emergency, which is estimated to increase throughout the 21st century (Guariguata et al., 2014). The prevalence of diabetes in Canada is increasing; in 2014, 6.7% of Canadians and 9% of Newfoundlanders and Labradorians had diabetes (Statistics Canada, 2014). In 2020 the number of people in Canada with diabetes is expected to rise to 2.5 million people, or 9.9% of the population (Canadian Diabetes Association, 2009).

Patients with diabetes are at risk for poor foot health and the estimated lifetime incidence of a diabetic foot ulcer (DFU) for this population is 25% (Singh, Armstrong, & Lipsky, 2005). In Canada in 2011 DFUs and related care cost the healthcare system 547 million dollars (Hopkins, Burke, Harlock, Jegathisawaran, & Goeree, 2015). Complicated DFUs that do not heal can lead to amputation; an estimated 85% of amputations are the result of a DFU (Canadian Association of Wound Care, 2015).

The increasing number of people with diabetes will result in a rise in foot complications such as DFUs (Canadian Diabetes Association, 2009). Therefore, it is important to develop strategies for the prevention of DFUs. An important aspect of maintaining foot health is self-management (Boulton et al., 2008; Chang, Peng, Chang, & Chen, 2013). However, there is limited literature related to the experiences of diabetic patients with foot management (Delea et al., 2015). As a result, little is known of the factors that need to be addressed to ensure successful uptake of a self-management strategy. Further exploration of the issue of foot self-assessment and self-management with patients and health care providers is needed in order to develop and implement effective and sustainable interventions.

Interventions to prevent DFUs need to provide patients with strategies to prevent skin breakdown. Due to neuropathy individuals with diabetes do not recognize the inflammation that occurs prior to skin breakdown. In many instances, by the time individuals have identified a problem the ulceration had already occurred (Lavery et al., 2004). For patients with diabetes factors such as pressure can contribute to inflammation and increase plantar foot temperature. Commercially available-infrared thermometers (CAITs) can be used to detect this temperature increase before skin breakdown. Once the increase is identified, the individual can relieve pressure, for example by resting, until the temperature normalizes and inflammation decreases. If the temperature does not normalize in two days then a physician should be consulted. Therefore, self-management strategies that focus on identifying and addressing early signs of inflammation, such as a temperature increase, may be effective in preventing skin breakdown.

Various systematic reviews, which contained three randomized control trials (RCTs), have indicated that the use of personal temperature monitoring with a medical grade thermometer was an effective way to predict, and thus prevent DFUs (Arad, Fonseca, Peters, & Vinik, 2011; Houghton, Bower, & Chant, 2013; van Netten et al., 2015). These thermometers cost approximately $700, which can be prohibitively expensive. A recent study compared inexpensive CAITs, that cost under $100, to medical infrared thermometers and found them to be a reliable measure of skin temperature (Mufti, Coutts, & Sibbald, 2015). However, this technology has not been used as part of an intervention and it is unknown if the CAIT will result in the same positive results as the medical grade thermometer. This study will fill this empirical gap.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

change from baseline foot assessment as evidenced by a diabetic foot ulcer

时间窗: time to ulceration up to 24 weeks

Screening for the high risk diabetic foot: A 60 second foot tool (2012) Sibbald

次要结局

  • change from baseline foot assessment as evidenced by presence or absence of skin breakdown(Completed by participant daily up to 24 weeks)
  • change from baseline foot assessment evidenced by presence or absence of redness(Completed by participant daily up to 24 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kathleen Stevens

Assistant Professor

Memorial University of Newfoundland

研究点 (2)

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