Tele-homecare Service for Diabetic Foot Patients (Risk 0, Risk 1 and Risk 2 Level): Testing and Validation of Dedicated APPs and Artificial Intelligence Solutions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Detection of vascular disorders
研究概览
简要总结
MY FOOT project aims at filling the gap in mobile applications by providing evidence to both involved stakeholders, that is the remote assistance from the hospital and the patient, who is directly involved in their own care strategy.
In particular, the application has to motivate patients and engage them in their self-care. Interaction with the mobile phone application is in the following terms:
APP elaborates data input from the patient in terms of own feeling of health status, symptoms revealed along the day, events eventually occurred, photos of the foot, including ulcer zoom (if any), APP reports back about increase / decrease in the Risk Level graph through time, maps the ulcer evolution or healing based on photos elaboration, using adequate graphs reporting time in the main axis, whilst reminds personal goals to enact care on a regular basis on the basis of the current conditions, eventually alerts the patient to contact clinicians for a visual inspection at a hospital.
详细描述
Without effective self-care, people with diabetic foot ulcers (DFUs) are at risk of prolonged healing times, hospitalization, amputation, and reduced quality of life. Despite these consequences, adherence to DFU self-care remains low.
As already pointed out in the preceding paragraphs, patient education in the prevention of diabetic foot ulcers found has been recognised as providing positive short-term effects on knowledge about care of the foot, delaying foot ulceration and amputation, especially in high-risk patients. New strategies are needed to engage people in the self-care of their DFUs.
Modern information technology may assist in attracting patients' interest if any direct benefit is promptly perceived by the patient who uses it . It is also of utmost importance that health professionals, especially those who work with diabetic patients on a daily basis, are aware of such practices and then be able to convince patients they merit the best care possible to avoid any further degradation of the pathology.
Mobile health apps hold great promise for people with diabetes, but few apps seek to engage people in their DFU self-care , , .
Schäfer et al. examined the risk factors of developing diabetic foot ulcers and amputation among patients with diabetes. They concluded that prediction and on-time treatment of diabetic foot ulcers (DFU) are of great importance for improving and maintaining patients' quality of life and avoiding the consequent socio-economic burden of amputation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The sample will include all the people accommodated in Special hospital Merkur, who sign the informed consent. Patients aged between 18 and 80 years. Patients diagnosed with Diabetes Mellitus (more than 5 years from diagnosis). Participant has adequate circulation to the affected extremity(ies), as demonstrated by at least ONE of the following within 60 days prior to enrolment/randomization: a) Dorsum transcutaneous oxygen test (TcPO2) of study leg(s) with results ≥40mmHg, OR, b) Ankle-Brachial Index (ABI) of study leg(s) with results of ≥ 0.7 and ≤ 1.3, OR; C) Toe-Brachial Index (TBI) of study extremity(ies) with results of ≥ 0.5.
排除标准
- •People who do not give their consent to participate in the study, who do not have a mobile phone, or live in an area not covered by a mobile signal and the Internet. Participant who is pregnant, breast feeding or planning to become pregnant. Participant having multiple foot ulcers, an amputation of the forefoot or an amputation at a more proximal location of the foot. Participant having a cancer disease or life expectancy less than six months as assessed by the investigator or undergoing cancer treatment; Participant having a severe foot infection; Active infection, undrained abscess, or critical colonization of the wound(s) with bacteria in the judgment of the investigator; Participant with Hgb A1c > 12 percent within 3 months prior to randomization; Participant with a known history of poor compliance with medical treatments.
结局指标
主要结局
Detection of vascular disorders
时间窗: 12 months
The diabetes care is implemented by highly qualified health care professionals and continuously supervised by the leading experts from the university hospitals in Serbia. Moreover, the professors of endocrinology, neurology, vascular surgeon and diabetology from the medical universities of Belgrade and Kragujevac and AGEL supervise all those activities
Detection of neurological disorders
时间窗: 12 months
The diabetes care is implemented by highly qualified health care professionals and continuously supervised by the leading experts from the university hospitals in Serbia. Moreover, the professors of endocrinology, neurology, vascular surgeon and diabetology from the medical universities of Belgrade and Kragujevac and AGEL supervise all those activities
次要结局
- Analysing of potential risk factors contributed into Risk 0 and 1(12 months)
- Analysing of potential precipitating factors for DFU(12 months)