Interest of Telemedicine in Primary Care in an Multidisability Population Institutionalized (TEDDY)
연구 개요
상태
상세 설명
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Sabine Crestani, MD
- 전화번호: +33 05 67 77 81 61
- 이메일: crestani.s@chu-toulouse.fr
연구 장소
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Montauban, 프랑스, 82 000
- FAM la Vitarelle
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연락하다:
- Dounia Akrouh
- 전화번호: +33 05 63 20 35 35
- 이메일: dounia.akrouh@asei.asso.fr
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수석 연구원:
- Dounia Akrouh
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Montauban, 프랑스, 82 000
- MAS de Granès
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연락하다:
- Dounia Akrouh
- 전화번호: +33 05 63 20 35 35
- 이메일: dounia.akrouh@asei.asso.fr
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수석 연구원:
- Dounia Akrouh
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Rieux-Volvestre, 프랑스, 31 310
- Mas Azure
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연락하다:
- Noémie Roussel
- 전화번호: +33 06 75 17 21 76
- 이메일: noemie.roussel@asei.asso.fr
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연락하다:
- Germain Huc, MD
- 전화번호: +33 05 81 44 10 01
- 이메일: germain.huc@asei.asso.fr
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수석 연구원:
- Noémie Roussel
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부수사관:
- Germain Huc, MD
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Toulouse, 프랑스, 31 059
- Larrey Hospital - Toulouse University Hospital
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연락하다:
- Sabine Crestani, MD
- 전화번호: +33 05 67 77 81 61
- 이메일: crestani.s@chu-toulouse.fr
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연락하다:
- Virginie Woisard, PHD
- 전화번호: +33 05 31 15 56 48
- 이메일: woisard.v@chu-toulouse.fr
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수석 연구원:
- Sabine Crestani, MD
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부수사관:
- Virginie Woisard, PHD
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Toulouse, 프랑스, 31200
- MAS Jean de la Fontaine
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연락하다:
- Anne Breuillaud
- 전화번호: +33 05 34 25 55 66
- 이메일: anne.breuillaud@asei.asso.fr
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연락하다:
- Gauthier Forni
- 전화번호: +33 07 65 56 88 66
- 이메일: gauthier.forni@asei.asso.fr
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수석 연구원:
- Anne Breuillaud
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부수사관:
- Gauthier Forni
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Patients aged ≥ 18 years living in a medical institution (MAS type, FAM from the ASEI network)
- Indication of a medical swallowing assessment in hospital
- Person affiliated to or beneficiary of a social security system.
- Free, informed and written consent signed by the participant or their guardian
Exclusion Criteria:
- Participation in another research including a period of exclusion still ongoing
- non-movable patient
- Pregnant woman, Woman of childbearing age without contraception
- any contraindication to nasofibroscopy and/or fluoroscopy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Patients with a deglutition disorder
All participants will have deglutition disorder.
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The teleconsultation will be scheduled by the UVD programming IDE after contact by the structure team.
This teleconsultation will take place in the presence of the patient's care assistant as well as medical staff (IDE, occupational therapist, physiotherapist, speech therapist, etc.) from the institution and a doctor specializing in swallowing and a speech therapist for the university hospital.
The resident will do a food test under the eyes of CHU specialists.
The patient will be able to test several textures (more or less solid/liquid) prepared in the center in order to be more accurate in their daily life.
The meal will be in his familiar environment with his usual caregivers and tools.
The CHU team will be able to interact directly with the institution's staff in order to have all the information necessary to determine their conclusions : questions, details on the patient's degree of compliance, etc.
Treatment for swallowing disorders in the hospital sector consists of the patient coming to the university hospital or to a day hospital in order to carry out a swallowing assessment consisting of invasive examinations such as nasofibroscopy (NF), swallowing fluoroscopy (VFS) as well as eating a meal outside the patient's usual context, sometimes in the presence of other people foreign to the patient (source of distractibility and sometimes anxiety).
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Recommendations on food textures
기간: 1 month
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Recommendations regarding food textures will be assessed using the IDDSI (International Dysphagia Diet Standardization Initiative) scale during the V1 telemedicine visit and the V2 outpatient visit 15 days later. This scale consists of 8 categories ranging from 0 ("liquid texture") to 7 ("normal texture"), which are used to assess patients' swallowing abilities. This scale will be used to assess the recommended solid-textured diet (IDDSI 3 to 7) and liquid-textured diet (IDDSI 0 to 4). The relevance between the results of the telemedicine and the outpatient visit will be assessed. |
1 month
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Evaluation of the satisfaction in the structures team
기간: 1 month
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Satisfaction will be assessed using a satisfaction questionnaire to be completed by caregivers or paramedical staff at medical facilities for the first telemedicine assessment (V1), and then by caregivers accompanying the patient for the second assessment in a hospital setting (V2). It will consist of 8 questions answered on a scale ranging from 1 to 10. These questions will address satisfaction, the extent to which the consultation was tailored to the patient's needs and disability, the patient's dietary habits and the level of difficulty in conducting the consultation. A "free text comments" field will be available. |
1 month
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Description of telemedicine treatment: feasibility
기간: 2 weeks
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It will be assessed based on a description of how the teleconsultation (V1) is organized and the patient's care pathway, the presence of the usual caregiver during meals, a description of the difficulties encountered in evaluating feasibility and the level of discomfort during the food trial using the ECPA scale (Behavioral Scale for Non-Communicative Older Adults) (composite criterion). The last scale is based on the observation of the patient's behavior and assesses facial expressions, movements, interactions with others and behavior during the meal. The higher the score, the more severe is the pain. |
2 weeks
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Description of telemedicine treatment: evaluation methods
기간: 2 weeks
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It will be assessed based on the description of the remote ecological evaluation, the assessment of the validity of the telemedicine examination among the various stakeholders, and the collection of data on the type of IDDSI food textures before and after treatment (composite criterion).
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2 weeks
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Description of care in the hospital sector: feasibility
기간: 1 month
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It will be assessed by describing the nature of the hospital visit (inpatient stay or outpatient visit), the presence of the usual caregiver, and the difficulties encountered in assessing feasibility, as well as the level of discomfort associated with medical procedures, using the ECPA scale (composite criterion).
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1 month
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Description of care in the hospital sector: evaluation methods
기간: 1 month
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It will be assessed based on the description of the examinations and procedures performed under optimal conditions:
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1 month
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공동 작업자 및 조사자
수사관
- 수석 연구원: Sabine Crestani, Service ORL - Hôpital Larrey
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
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. .