Medico-economic Evaluation of a Project of Wounds by a Remote Network (DOMOPLAIES)

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

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).

Study Overview

• Status: Completed
• Conditions: Resident of Languedoc-roussillon; Carrying a Chronic Wound
• Intervention / Treatment: Other: Control; Other: Telemedicine

• Study Type: Interventional
• Enrollment (Actual): 193
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Wound healing Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Telemedicine
Active Comparator: 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.	Other: Control

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: September 2, 2015
• First Submitted That Met QC Criteria: September 9, 2015
• First Posted (Estimate): September 10, 2015

Study Record Updates

• Last Update Posted (Estimate): April 12, 2016
• Last Update Submitted That Met QC Criteria: April 11, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: telemedicine; Smartphone; tablet; chronic wound; wounds consultation
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 9250