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NCT Number: NCT07792187

Interest of Telemedicine in Primary Care in an Multidisability Population Institutionalized

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

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Key information

Conditions

Deglutition Disorders in Disabled Persons Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

FAM la Vitarelle, Montauban, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental procedure: swallowing assessment by telemedicine

Other

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.

Standard procedure: day hospitalization

Other

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).

Primary outcomes

  1. Recommendations on food textures

    Time frame: 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.

Secondary outcomes

  1. Evaluation of the satisfaction in the structures team

    Time frame: 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.

  2. Description of telemedicine treatment: feasibility

    Time frame: 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.

  3. Description of telemedicine treatment: evaluation methods

    Time frame: 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).

  4. Description of care in the hospital sector: feasibility

    Time frame: 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).

  5. Description of care in the hospital sector: evaluation methods

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Sabine Crestani, MD

CONTACT

[email protected]

05 67 77 81 61 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: TEDDY

Important dates

Study start
2027
Primary completion
2030
Study completion
2030
First posted
Aug 28, 2026
Registry last updated
Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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