Interest of Telemedicine in Primary Care in an Multidisability Population Institutionalized (TEDDY)
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Sabine Crestani, MD
- Telefonnummer: +33 05 67 77 81 61
- E-post: crestani.s@chu-toulouse.fr
Studieorter
-
-
-
Montauban, Frankrike, 82 000
- FAM la Vitarelle
-
Kontakt:
- Dounia Akrouh
- Telefonnummer: +33 05 63 20 35 35
- E-post: dounia.akrouh@asei.asso.fr
-
Huvudutredare:
- Dounia Akrouh
-
Montauban, Frankrike, 82 000
- MAS de Granès
-
Kontakt:
- Dounia Akrouh
- Telefonnummer: +33 05 63 20 35 35
- E-post: dounia.akrouh@asei.asso.fr
-
Huvudutredare:
- Dounia Akrouh
-
Rieux-Volvestre, Frankrike, 31 310
- Mas Azure
-
Kontakt:
- Noémie Roussel
- Telefonnummer: +33 06 75 17 21 76
- E-post: noemie.roussel@asei.asso.fr
-
Kontakt:
- Germain Huc, MD
- Telefonnummer: +33 05 81 44 10 01
- E-post: germain.huc@asei.asso.fr
-
Huvudutredare:
- Noémie Roussel
-
Underutredare:
- Germain Huc, MD
-
Toulouse, Frankrike, 31 059
- Larrey Hospital - Toulouse University Hospital
-
Kontakt:
- Sabine Crestani, MD
- Telefonnummer: +33 05 67 77 81 61
- E-post: crestani.s@chu-toulouse.fr
-
Kontakt:
- Virginie Woisard, PHD
- Telefonnummer: +33 05 31 15 56 48
- E-post: woisard.v@chu-toulouse.fr
-
Huvudutredare:
- Sabine Crestani, MD
-
Underutredare:
- Virginie Woisard, PHD
-
Toulouse, Frankrike, 31200
- MAS Jean de la Fontaine
-
Kontakt:
- Anne Breuillaud
- Telefonnummer: +33 05 34 25 55 66
- E-post: anne.breuillaud@asei.asso.fr
-
Kontakt:
- Gauthier Forni
- Telefonnummer: +33 07 65 56 88 66
- E-post: gauthier.forni@asei.asso.fr
-
Huvudutredare:
- Anne Breuillaud
-
Underutredare:
- Gauthier Forni
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Patients with a deglutition disorder
All participants will have deglutition disorder.
|
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).
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Recommendations on food textures
Tidsram: 1 month
|
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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Evaluation of the satisfaction in the structures team
Tidsram: 1 month
|
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
|
|
Description of telemedicine treatment: feasibility
Tidsram: 2 weeks
|
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
|
|
Description of telemedicine treatment: evaluation methods
Tidsram: 2 weeks
|
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).
|
2 weeks
|
|
Description of care in the hospital sector: feasibility
Tidsram: 1 month
|
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).
|
1 month
|
|
Description of care in the hospital sector: evaluation methods
Tidsram: 1 month
|
It will be assessed based on the description of the examinations and procedures performed under optimal conditions:
|
1 month
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Sabine Crestani, Service ORL - Hôpital Larrey
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- RC31/24/0427
- 2025-A02816-43 (Annan identifierare: ID-RCB)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .