Medico-economic Evaluation of a Project of Wounds by a Remote Network

Study Overview
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Brief Summary
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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).

Official Title
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Medico-economic Evaluation of the DOMOPLAIES Project by the CICAT-LR Network

Conditions
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Resident of Languedoc-roussillon, Carrying a Chronic Wound

Intervention / Treatment
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* Other: Telemedicine
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemedicine<br>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. | Other: Telemedicine<br> <br> |
| Active Comparator: Control<br>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. | Other: Control<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of healed chronic wounds during a telemedicine care | Rate of healed chronic wounds during a telemedicine care versus during a usual medical care | Six months after inclusion | 
| Rate of healed chronic wounds during a usual medical care | Rate of healed chronic wounds during a telemedicine care versus during a usual medical care | Six months after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Result to the questionnaire on the quality of life: EQ-5D | Compare the quality of life of patients with chronic wounds during a telemedicine coverage versus during a usual medical care, thanks to the EQ-5D quality life scale. | Six months after inclusion | 
| A measure of the costs of the management of the disease | A measure of the costs of the management of the disease (consumer care, hospitalization, transport ...) | Seven months after the inclusion of the last patient | 
| A measure of the costs of the intervention assessed | A measure of the costs of the intervention assessed (investment, maintenance, training ...). | Seven months after the inclusion of the last patient | 
| The total healing time |  | Six months after inclusion | 
| The decrease in centimeters of the wound surface to 6 months |  | Six months after inclusion | 
| The response time between making an appointment and support |  | Six months after inclusion | 
| The mortality rate within 6 months |  | Six months after inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic wound, tablet, telemedicine, wounds consultation, Smartphone