Medico-economical Assessment of Telemedicine During Chronic Diabetes-related Foot Wound Management
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Assess the incremental cost-effectiveness ratio from the french health system perspective
研究概览
简要总结
The aim of the study is to assess the cost-effectiveness of telemedicine in the care of chronic diabetic foot ulcers.
Patients will be randomized into 2 groups: 1/conventional care group with iterative visits to diabetes specialist or 2/innovative care (telemedicine group).
the health insurance system perspective is adopted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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 with type 1 or 2 diabetes, at least 18 years old
- •Patient with a diabetic foot wound :
- •Acute or chronic (evolving for at least 30 days)
- •size ≤ to 3 cm²
- •Level I, II or III, stage A or B, excluding stages C and D from the University of Texas Wound Classification Systems
- •Person affiliated to French Health insurance or equivalent
- •Person having signed freely the consent form after receiving sufficient information
- •Treatment compliance and 6 months follow-up feasible
排除标准
- •Patient with a ischemic wound: Ankle-Brachial Index (ABI) <0.9 or Transcutaneous oxygen pressure (TcpO2) < 30 mmHg (stage C and D from the University of Texas Wound Classification Systems)
- •Patient with emergency hospitalization indication whatever the reasons.
- •Person deprived of liberty by a legal or administrative decision, patients in emergency and people hospitalised without consent and who are not protected by law.
- •Pregnant or breastfeeding women
- •Patient currently participating in another telemedicine research protocol (such as : Study on the impact of Telemedicine on the management of patients with type 1 diabetes (TELEDIAB-3))
研究组 & 干预措施
Telemedicine
care and follow-up through telemedicine.
干预措施: telemedicine (Other)
Conventional care
care and follow-up through iterative diabetes physician consultations (conventional care and follow-up)
干预措施: conventional (Other)
结局指标
主要结局
Assess the incremental cost-effectiveness ratio from the french health system perspective
时间窗: 6 months
It is elaborated from: 1. Main cost criteria: transport, outpatient costs (home nursing care, physicians consultations...), loss of productivity (absence from work) 2. Main clinical effectiveness criterion: wound healing time.
次要结局
- Assess acceptability of telemedicine care (compliance and satisfaction) for patients and nurses.(6 months)
- Assess the Impact of telemedicine care from the hospital perspective(6 months)
研究者
AdministrateurCIC
Pr Pierre-Yves BENHAMOU, University Hospital, Grenoble
University Hospital, Grenoble