Medico-economic Evaluation of the DOMOPLAIES Project by the CICAT-LR Network
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 193
- 试验地点
- 1
- 主要终点
- Rate of healed chronic wounds during a telemedicine care
研究概览
简要总结
Estimate in 6 months the impact of the telemedicine on the cure rate of the chronic wounds compared with the usual care(with or without CICAT-LR Network).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Being adult
- •Taken up residence on the Languedoc-Roussillon
- •Patient carrying a wound with healing or improvement objective (wound closure or the appearance of 40% of granulation)
- •Informed consent signed,
- •Patient member of the Security Social
- •Patient having a visiting nurse.
排除标准
- •Patient in vital or functional emergency situation during the first call or during the consultation
- •Tumoral wound
- •dialysis patient
- •Arteritis of stage 4 and not revascularizable
- •Absence of regular doctor and visiting nurse
- •patient refusal
- •Refusal of one of the health professionals participating in the pathology care
- •Anybody incapable to communicate and to answer the questions
- •Pregnant or nursing woman
- •Subject deprived of freedom by court or administrative order
- •Major subject protected by the law
- •For the patients in telemedicine: refusal of the collaboration agreement
研究组 & 干预措施
Telemedicine
In the telemedicine arm, all patients will be supported by Telemedicine protocol according to the development of telemedicine in the region.
The use of teleconsultation allows the couple expert doctor / nurse expert to perform a complex of wound assessment consultation and / or chronic. The use of telemedicine allows for acts of telecare, when the nurse applicant sought a remote support of an expert nurse (under the responsibility of a doctor) for the realization of an act. The use of tele-expertise enables physicians to remotely bring special expertise to improve patient care.
干预措施: Telemedicine (Other)
Control
In the control arm, patient care depend on his home, as is currently the case:
- If it is in the action zone of Cicat-LR network, then it will be supported by an expert nurse of the network that are physically visit the patient's home-lon is the protocols established by the network.
- If not, then it will be supported by the customs of the attending physician and nursing teams who follow him.
干预措施: Control (Other)
结局指标
主要结局
Rate of healed chronic wounds during a telemedicine care
时间窗: Six months after inclusion
Rate of healed chronic wounds during a telemedicine care versus during a usual medical care
Rate of healed chronic wounds during a usual medical care
时间窗: Six months after inclusion
Rate of healed chronic wounds during a telemedicine care versus during a usual medical care
次要结局
- The response time between making an appointment and support(Six months after inclusion)
- The decrease in centimeters of the wound surface to 6 months(Six months after inclusion)
- The mortality rate within 6 months(Six months after inclusion)
- The total healing time(Six months after inclusion)
- Result to the questionnaire on the quality of life: EQ-5D(Six months after inclusion)
- A measure of the costs of the management of the disease(Seven months after the inclusion of the last patient)
- A measure of the costs of the intervention assessed(Seven months after the inclusion of the last patient)