Interest of Telemedicine in Primary Care in an Multidisability Population Institutionalized (TEDDY)
調査の概要
状態
詳細な説明
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Sabine Crestani, MD
- 電話番号：+33 05 67 77 81 61
- メール：crestani.s@chu-toulouse.fr
研究場所
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Montauban、フランス、82 000
- FAM la Vitarelle
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コンタクト：
- Dounia Akrouh
- 電話番号：+33 05 63 20 35 35
- メール：dounia.akrouh@asei.asso.fr
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主任研究者：
- Dounia Akrouh
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Montauban、フランス、82 000
- MAS de Granès
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コンタクト：
- Dounia Akrouh
- 電話番号：+33 05 63 20 35 35
- メール：dounia.akrouh@asei.asso.fr
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主任研究者：
- Dounia Akrouh
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Rieux-Volvestre、フランス、31 310
- Mas Azure
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コンタクト：
- Noémie Roussel
- 電話番号：+33 06 75 17 21 76
- メール：noemie.roussel@asei.asso.fr
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コンタクト：
- Germain Huc, MD
- 電話番号：+33 05 81 44 10 01
- メール：germain.huc@asei.asso.fr
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主任研究者：
- Noémie Roussel
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副調査官：
- Germain Huc, MD
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Toulouse、フランス、31 059
- Larrey Hospital - Toulouse University Hospital
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コンタクト：
- Sabine Crestani, MD
- 電話番号：+33 05 67 77 81 61
- メール：crestani.s@chu-toulouse.fr
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コンタクト：
- Virginie Woisard, PHD
- 電話番号：+33 05 31 15 56 48
- メール：woisard.v@chu-toulouse.fr
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主任研究者：
- Sabine Crestani, MD
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副調査官：
- Virginie Woisard, PHD
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Toulouse、フランス、31200
- MAS Jean de la Fontaine
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コンタクト：
- Anne Breuillaud
- 電話番号：+33 05 34 25 55 66
- メール：anne.breuillaud@asei.asso.fr
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コンタクト：
- Gauthier Forni
- 電話番号：+33 07 65 56 88 66
- メール：gauthier.forni@asei.asso.fr
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主任研究者：
- Anne Breuillaud
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副調査官：
- Gauthier Forni
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Recommendations on food textures
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Evaluation of the satisfaction in the structures team
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Sabine Crestani、Service ORL - Hôpital Larrey
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。