- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
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Montpellier, Frankrig, 34295
- Wound healing Department
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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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Aktiv komparator: Control
In the control arm, patient care depend on his home, as is currently the case:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Rate of healed chronic wounds during a telemedicine care
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Result to the questionnaire on the quality of life: EQ-5D
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Six months after inclusion
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Six months after inclusion
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The mortality rate within 6 months
Tidsramme: Six months after inclusion
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Six months after inclusion
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 9250
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