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

Not Applicable

Completed

• Conditions: Resident of Languedoc-roussillon; Carrying a Chronic Wound
• Interventions: Other: Control; Other: Telemedicine

• Registration Number: NCT02545374
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2015-09-02
• Study First Submitted QC: 2015-09-09
• Study First Posted: 2015-09-10
• Primary Completion: 2015-10
• Study Completion: 2016-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-11
• Last Update Posted: 2016-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 193

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	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.
Telemedicine	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.

Primary Outcome Measures

Name	Time	Method
Rate of healed chronic wounds during a telemedicine care	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	Six months after inclusion	Rate of healed chronic wounds during a telemedicine care versus during a usual medical care

Secondary Outcome Measures

Name	Time	Method
The mortality rate within 6 months	Six months after inclusion
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 total healing time	Six months after inclusion
Result to the questionnaire on the quality of life: EQ-5D	Six months after inclusion	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.
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 management of the disease (consumer care, hospitalization, transport ...)
A measure of the costs of the intervention assessed	Seven months after the inclusion of the last patient	A measure of the costs of the intervention assessed (investment, maintenance, training ...).

Trial Locations

Locations (1)

Wound healing Department; 🇫🇷 Montpellier, France