Medico-Economic Impact of Telemonitoring Chronic Wounds With Pixacare
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
- To demonstrate the superiority of a strategy based on home telemonitoring of patients, compared with a conventional follow-up strategy, in reducing the number of in-person consultations with specialized physicians among patients with chronic wounds
研究概览
简要总结
The healing of chronic wounds extends over several months and accounts for 3% of the healthcare budget. Care networks capable of managing chronic wounds are heterogeneous, insufficient, and poorly coordinated across the country.
The key levers identified to reduce the costs of chronic wound care are: reducing the number of consultations, shortening healing time, decreasing the weekly frequency of care, and enabling early management of complications through an alert system.
The Ministry of Health now aims to roll out telemonitoring into mainstream practice and to expand new telemonitoring structures to benefit new patients and new pathologies.
A review of the literature on telemedicine in general reveals numerous indicators confirming the strong potential of telemonitoring for chronic wounds to improve care efficiency.
It would allow specialized remote follow-up without adding workload for caregivers while reducing the number of in-person consultations. This expert oversight could lead to better-adapted treatments, resulting in faster healing and a reduced frequency of care.
Adverse developments and complications could also be detected and managed early through an alert system.
No controlled study using a digital tool with an alert system currently undergoing CE class IIa marking has yet effectively assessed the organizational and medical benefits of such telemonitoring for the management of chronic wounds. This is the objective of this research.
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
- •Adult patient aged over 18 years
- •Suffering from a single chronic wound, meaning a wound of any origin evolving for more than 6 weeks (diabetic foot ulcer, leg ulcer, or pressure ulcer) Patient seen in a specialized consultation at Lille University Hospital (CHU de Lille) for wound management (Diabetology Department, Plastic Surgery Department)
- •A home-based wound-care protocol planned at the time of inclusion
- •Patients owning a smartphone or a tablet at home
- •Patient willing to comply with all study procedures and duration
- •Patient who has provided written informed consent to participate in the study
- •Patient covered by national health insurance
排除标准
- •Minor patient
- •Pregnant woman
- •Patient hospitalized at the time of inclusion (except for home hospitalization, HAD)
- •Multiple wounds
- •Wound not appearing flat in the photograph
- •A home nurse (RN) who is already following a patient from one study group may not follow another patient from the other group (control or telemonitoring) Inability to receive informed information, inability to participate in the full duration of the study, lack of health insurance coverage, refusal to sign the consent form
- •Patient under guardianship or curatorship
研究组 & 干预措施
Experimental group
Telemonitoring of patients at home with chronic wounds. The home nurse (RN) performs dressing changes according to the care protocol.
The patient takes photographs of the wound and completes the questionnaire using the Pixacare tele-upload application. If needed, a caregiver may assist the patient in taking the photographs.
The study ends 16 weeks after randomization.
干预措施: Pixacare (Device)
Control group
Conventional home follow-up of patients with chronic wounds. The home nurse (RN) performs dressing changes according to the care protocol.
The study ends 16 weeks after randomization.
结局指标
主要结局
To demonstrate the superiority of a strategy based on home telemonitoring of patients, compared with a conventional follow-up strategy, in reducing the number of in-person consultations with specialized physicians among patients with chronic wounds
时间窗: 16 weeks
次要结局
- To compare, between the two groups (telemonitoring and conventional follow-up), the number of complications (infections, amputations).(16 weeks)
- Wound-healing kinetics measured as the percentage reduction in wound area from baseline to end of study(16 weeks)
- To compare, between the two groups (telemonitoring and conventional follow-up), the weekly frequency of dressing changes(16 weeks)
- To compare, between the two groups (telemonitoring and conventional follow-up), the number and cumulative duration of hospitalizations related to the wound.(16 weeks)
- Patient satisfaction score measured using a standardized digital satisfaction questionnaire integrated into the telemonitoring application(16 weeks)