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- Klinische proef NCT02545374
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
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Montpellier, Frankrijk, 34295
- Wound healing Department
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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. |
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Actieve vergelijker: Control
In the control arm, patient care depend on his home, as is currently the case:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Rate of healed chronic wounds during a telemedicine care
Tijdsspanne: Six months after inclusion
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Rate of healed chronic wounds during a telemedicine care versus during a usual medical care
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Six months after inclusion
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Rate of healed chronic wounds during a usual medical care
Tijdsspanne: Six months after inclusion
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Rate of healed chronic wounds during a telemedicine care versus during a usual medical care
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Six months after inclusion
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Result to the questionnaire on the quality of life: EQ-5D
Tijdsspanne: Six months after inclusion
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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.
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Six months after inclusion
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A measure of the costs of the management of the disease
Tijdsspanne: Seven months after the inclusion of the last patient
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A measure of the costs of the management of the disease (consumer care, hospitalization, transport ...)
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Seven months after the inclusion of the last patient
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A measure of the costs of the intervention assessed
Tijdsspanne: Seven months after the inclusion of the last patient
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A measure of the costs of the intervention assessed (investment, maintenance, training ...).
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Seven months after the inclusion of the last patient
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The total healing time
Tijdsspanne: Six months after inclusion
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Six months after inclusion
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The decrease in centimeters of the wound surface to 6 months
Tijdsspanne: Six months after inclusion
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Six months after inclusion
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The response time between making an appointment and support
Tijdsspanne: Six months after inclusion
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Six months after inclusion
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The mortality rate within 6 months
Tijdsspanne: Six months after inclusion
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Six months after inclusion
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Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Geschat)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 9250
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