- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Montpellier, 프랑스, 34295
- Wound healing Department
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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활성 비교기: Control
In the control arm, patient care depend on his home, as is currently the case:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Rate of healed chronic wounds during a telemedicine care
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Result to the questionnaire on the quality of life: EQ-5D
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Six months after inclusion
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Six months after inclusion
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The mortality rate within 6 months
기간: Six months after inclusion
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Six months after inclusion
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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