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Interest of Telemedicine in Primary Care in an Multidisability Population Institutionalized (TEDDY)

24. august 2026 opdateret af: University Hospital, Toulouse
Swallowing disorders are common and fall within the scope of primary care (as basic, essential health services accessible to all individuals within a community). These swallowing disorders, strongly linked to the environment, do not require, in the majority of cases, a technical and intrusive evaluation. The main objective of this project is to study the relevance of an assessment of dysphagia by teleconsultation

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Experimental procedure: swallowing assessment by telemedicine. During this teleconsultation, the resident will do a food test under the eyes of the CHU specialists. Then an hospitalisation will be done with instrumental evaluation. To complete this visit, a teleexpertise will be scheduled approximately 1 month later.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

62

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Frankrig
      • Montauban, Frankrig, 82 000
        • FAM la Vitarelle
        • Kontakt:
        • Ledende efterforsker:
          • Dounia Akrouh
      • Montauban, Frankrig, 82 000
        • MAS de Granès
        • Kontakt:
        • Ledende efterforsker:
          • Dounia Akrouh
      • Rieux-Volvestre, Frankrig, 31 310
        • Mas Azure
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Noémie Roussel
        • Underforsker:
          • Germain Huc, MD
      • Toulouse, Frankrig, 31 059
        • Larrey Hospital - Toulouse University Hospital
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Sabine Crestani, MD
        • Underforsker:
          • Virginie Woisard, PHD
      • Toulouse, Frankrig, 31200
        • MAS Jean de la Fontaine
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Anne Breuillaud
        • Underforsker:
          • Gauthier Forni

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Patients with a deglutition disorder
All participants will have deglutition disorder.
Andet: Experimental procedure: swallowing assessment by telemedicine
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.
Andet: Standard procedure: day hospitalization
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).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Recommendations on food textures
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Evaluation of the satisfaction in the structures team
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 1 month

It will be assessed based on the description of the examinations and procedures performed under optimal conditions:

  • speech-language assessment
  • nasofibroscopy,
  • fluoroscopy of swallowing,
  • consumption of a meal outside the patient's usual daily routine. For the last 3 procedures, the ECPA scale will be used. The diagnostic value of the examination will also be evaluated (composite criterion).
1 month

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital, Toulouse

Efterforskere

  • Ledende efterforsker: Sabine Crestani, Service ORL - Hôpital Larrey

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. januar 2027

Primær færdiggørelse (Anslået)

1. juni 2030

Studieafslutning (Anslået)

1. juni 2030

Datoer for studieregistrering

Først indsendt

24. august 2026

Først indsendt, der opfyldte QC-kriterier

24. august 2026

Først opslået (Faktiske)

28. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RC31/24/0427
  • 2025-A02816-43 (Anden identifikator: ID-RCB)

Plan for individuelle deltagerdata (IPD)

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