Comparative Study, Randomized in Parallel Groups, Evaluating the Consequences of the Management of Diabetic Foot Ulcers by Telemedicine Versus Conventional Monitoring on the Number of Hospital Days in Diabetic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Number of hospitalization days related to diabetic foot ulcers after one year of follow-up
研究概览
简要总结
The TELEPIED project aims to show that it is possible to reduce the number of hospitalization days of a patient with ulcers of the foot thanks to a new organization of care, based on the intervention of a coordinating nurse interacting with the nurse in charge of the patient thanks to a telemedicine tool allowing the transfer of photos and ensuring itself a regular follow-up of the evolution of the wound and adapting the support nurse to the home if necessary.
It is a monocenter, randomized, in parallel study, in 180 diabetic patients with ulcers of the foot.
Patients included in the conventional group will be followed according to the usual practice Patients included in the "telepied" group will benefit from a personalized accompaniment by a nurse referring to diabetic foot ulcers who will guide and advise the nurse at home by acting by delegating tasks of the investigator.
The patient will be visited by the referring nurse every 15 days. During these visits, the referring nurse will have the objective to evaluate the evolution of the ulcer as well as the care performed. This visit also allows a close personalized accompaniment for the patient, who will benefit from an education adapted to the characteristics of ulcer (discharge modalities for example ..) and its way of life.
Every patients will be followed for one year (12 months).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •Patients over 18 years
- •Diabetic patients with foot ulcer
- •Patient who agreed to participate in the study and sign free and informed consent
- •Patient affiliated to a social security scheme
排除标准
- •Pregnant Woman
- •Patient deprived of liberty by a judicial or administrative decision or a person subject to a legal protection measure
- •Patient already involved in another clinical trial protocol
研究组 & 干预措施
Conventionnal Group
No intervention for this group. Patients will be followed by a usual care.
"Telepied" Group
Patients will be followed by a nurse referring to ulcers of the diabetic foot.
干预措施: Taking pictures (Behavioral)
"Telepied" Group
Patients will be followed by a nurse referring to ulcers of the diabetic foot.
干预措施: Visit at home (Behavioral)
结局指标
主要结局
Number of hospitalization days related to diabetic foot ulcers after one year of follow-up
时间窗: 12 months
次要结局
- Patient satisfaction score(12 months)
- Total direct care costs between the Telepied group and the control group(12 months)
- Average duration of hospitalizations for an ulcer of the foot in the Telepied group versus the control group(12 months)
- Amputation rate between the two groups(12 months)
- Ulcer recidivism rate in the Telepied group versus control group.(12 months)
- Frequency of ulceration(12 months)
- Duration of ulceration(12 months)
- Healing rate between the Telepied group and the control group(12 months)