Interest of Telemedicine in Primary Care in an Multidisability Population Institutionalized (TEDDY)
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Sabine Crestani, MD
- Numéro de téléphone: +33 05 67 77 81 61
- E-mail: crestani.s@chu-toulouse.fr
Lieux d'étude
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Montauban, France, 82 000
- FAM la Vitarelle
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Contact:
- Dounia Akrouh
- Numéro de téléphone: +33 05 63 20 35 35
- E-mail: dounia.akrouh@asei.asso.fr
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Chercheur principal:
- Dounia Akrouh
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Montauban, France, 82 000
- MAS de Granès
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Contact:
- Dounia Akrouh
- Numéro de téléphone: +33 05 63 20 35 35
- E-mail: dounia.akrouh@asei.asso.fr
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Chercheur principal:
- Dounia Akrouh
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Rieux-Volvestre, France, 31 310
- Mas Azure
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Contact:
- Noémie Roussel
- Numéro de téléphone: +33 06 75 17 21 76
- E-mail: noemie.roussel@asei.asso.fr
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Contact:
- Germain Huc, MD
- Numéro de téléphone: +33 05 81 44 10 01
- E-mail: germain.huc@asei.asso.fr
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Chercheur principal:
- Noémie Roussel
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Sous-enquêteur:
- Germain Huc, MD
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Toulouse, France, 31 059
- Larrey Hospital - Toulouse University Hospital
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Contact:
- Sabine Crestani, MD
- Numéro de téléphone: +33 05 67 77 81 61
- E-mail: crestani.s@chu-toulouse.fr
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Contact:
- Virginie Woisard, PHD
- Numéro de téléphone: +33 05 31 15 56 48
- E-mail: woisard.v@chu-toulouse.fr
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Chercheur principal:
- Sabine Crestani, MD
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Sous-enquêteur:
- Virginie Woisard, PHD
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Toulouse, France, 31200
- MAS Jean de la Fontaine
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Contact:
- Anne Breuillaud
- Numéro de téléphone: +33 05 34 25 55 66
- E-mail: anne.breuillaud@asei.asso.fr
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Contact:
- Gauthier Forni
- Numéro de téléphone: +33 07 65 56 88 66
- E-mail: gauthier.forni@asei.asso.fr
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Chercheur principal:
- Anne Breuillaud
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Sous-enquêteur:
- Gauthier Forni
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Recommendations on food textures
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Evaluation of the satisfaction in the structures team
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Sabine Crestani, Service ORL - Hôpital Larrey
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- RC31/24/0427
- 2025-A02816-43 (Autre identifiant: ID-RCB)
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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