Interest of Telemedicine in Primary Care in an Multidisability Population Institutionalized (TEDDY)
Studieoversikt
Status
Detaljert beskrivelse
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Sabine Crestani, MD
- Telefonnummer: +33 05 67 77 81 61
- E-post: crestani.s@chu-toulouse.fr
Studiesteder
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Montauban, Frankrike, 82 000
- FAM la Vitarelle
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Ta kontakt med:
- Dounia Akrouh
- Telefonnummer: +33 05 63 20 35 35
- E-post: dounia.akrouh@asei.asso.fr
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Hovedetterforsker:
- Dounia Akrouh
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Montauban, Frankrike, 82 000
- MAS de Granès
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Ta kontakt med:
- Dounia Akrouh
- Telefonnummer: +33 05 63 20 35 35
- E-post: dounia.akrouh@asei.asso.fr
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Hovedetterforsker:
- Dounia Akrouh
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Rieux-Volvestre, Frankrike, 31 310
- Mas Azure
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Ta kontakt med:
- Noémie Roussel
- Telefonnummer: +33 06 75 17 21 76
- E-post: noemie.roussel@asei.asso.fr
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Ta kontakt med:
- Germain Huc, MD
- Telefonnummer: +33 05 81 44 10 01
- E-post: germain.huc@asei.asso.fr
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Hovedetterforsker:
- Noémie Roussel
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Underetterforsker:
- Germain Huc, MD
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Toulouse, Frankrike, 31 059
- Larrey Hospital - Toulouse University Hospital
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Ta kontakt med:
- Sabine Crestani, MD
- Telefonnummer: +33 05 67 77 81 61
- E-post: crestani.s@chu-toulouse.fr
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Ta kontakt med:
- Virginie Woisard, PHD
- Telefonnummer: +33 05 31 15 56 48
- E-post: woisard.v@chu-toulouse.fr
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Hovedetterforsker:
- Sabine Crestani, MD
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Underetterforsker:
- Virginie Woisard, PHD
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Toulouse, Frankrike, 31200
- MAS Jean de la Fontaine
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Ta kontakt med:
- Anne Breuillaud
- Telefonnummer: +33 05 34 25 55 66
- E-post: anne.breuillaud@asei.asso.fr
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Ta kontakt med:
- Gauthier Forni
- Telefonnummer: +33 07 65 56 88 66
- E-post: gauthier.forni@asei.asso.fr
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Hovedetterforsker:
- Anne Breuillaud
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Underetterforsker:
- Gauthier Forni
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Recommendations on food textures
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Evaluation of the satisfaction in the structures team
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Sabine Crestani, Service ORL - Hôpital Larrey
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RC31/24/0427
- 2025-A02816-43 (Annen identifikator: ID-RCB)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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