Identification of Critical Outcomes in Sarcopenia (DCE-Sarcopenia)
Identification of Critical Outcomes in Sarcopenia: a Discrete Choice Experiment
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
The participants will first receive an information letter and consent form. Participants will be free to ask any questions to the doctor/researcher. Once the consent form signed, participants will receive the questionnaire and will be asked to complete it. Explanation of the task and an example choice task should be provided by a doctor or a researcher but the questionnaire is intended to be self-administered. Nevertheless, some level of support can be brought if necessary.
The questionnaire is composed by a general explanation of the purpose of the study followed by a definition of sarcopenia and a clear description of the DCE task. The attributes and levels are carefully explained in the introduction part of the questionnaire and an example of a completed choice set is provided. Each patient will then receive 13 choice sets. After completion of the choice tasks, respondents will be asked how difficult they found the choice tasks on a seven-point scale. Participants who graded the level of difficulty as "extremely difficult" will be removed from the analyses. The DCE task is presented in Appendix 1. The questionnaire also asks questions on patients' characteristics.
The questionnaire has been created with experts during the phase of "Identification and prioritization of important outcomes of sarcopenia". Five attributes and different levels of consequences have been identified by the panel.
Typ studiów
Zapisy (Rzeczywisty)
Kontakty i lokalizacje
Lokalizacje studiów
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Toulouse, Francja, 31059
- University Hospital Toulouse
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
Opis
Inclusion Criteria:
- Patients with Diagnosis of sarcopenia :
- Muscle mass
- Muscle strength and physical performance should be measured
Exclusion Criteria:
- Problem of Cognitive function
- Diagnosis of dementia
- unability to understand the study and the the questionnaire
- unability to fill in the questionnaire
- major depression
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
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Patient suffering from sarcopenia
Subjects aged 65 years or older suffering from sarcopenia (diagnosis performed with a valid definition and valid cut-off points) and they will respond to the Questionnaire composed of 13 choice questions.
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In this Discrete Choice Experiment (DCE), patients will be asked to choose which one of two hypothetical patients (Patient A and Patient B) suffering from sarcopenia with different levels of outcomes deserves the most the treatment.
After completion of the choice tasks, respondents will be asked how difficult they found the choice tasks on a seven-point scale and to questions on their socio-economic and disease characteristics.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Quality of life of the patient who are living with Sarcopenia
Ramy czasowe: 1 hour
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Good, Fair, Poor : the choices in the questionnaire The attributes and levels are carefully explained in the introduction part of the questionnaire and an example of a completed choice set is provided The quality of life is one of the five attributes and different levels of consequences have been identified by the panel.
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1 hour
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Mobility
Ramy czasowe: 1 hour
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The questionnaire is composed by a general explanation of the purpose of the study followed by a definition of sarcopenia and a clear description of the DCE task.
The attributes and levels are carefully explained in the introduction part of the questionnaire and an example of a completed choice set is provided.
Each patient will then receive 13 choice sets.
After completion of the choice tasks, respondents will be asked how difficult they found the choice tasks on a seven-point scale Possibilities in the questionnaire for the mobility part : Outdoor without difficulties, Outdoor with difficulties, Indoor only, Chairbound, Bedbound The attributes and levels are carefully explained in the introduction part of the questionnaire and an example of a completed choice set is provided The mobility is one of the five attributes and different levels of consequences have been identified by the panel.
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1 hour
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Capacity of doing domestic activities
Ramy czasowe: 1 hour
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The questionnaire is composed by a general explanation of the purpose of the study followed by a definition of sarcopenia and a clear description of the DCE task.
The attributes and levels are carefully explained in the introduction part of the questionnaire and an example of a completed choice set is provided.
Each patient will then receive 13 choice sets.
After completion of the choice tasks, respondents will be asked how difficult they found the choice tasks on a seven-point scale Possibilities in the questionnaire for the capacity of doing domestic activities: Manage without difficulties, Manage with difficulty, Unable for domestic activities such as cooking, cleaning, gardening The attributes and levels are carefully explained in the introduction part of the questionnaire and an example of a completed choice set is provided The capacity of doing domestic activities is one of the five attributes and different levels of consequences have been identified by the panel.
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1 hour
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The level of Fatigue
Ramy czasowe: 1 hour
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The questionnaire is composed by a general explanation of the purpose of the study followed by a definition of sarcopenia and a clear description of the DCE task. The attributes and levels are carefully explained in the introduction part of the questionnaire and an example of a completed choice set is provided. Each patient will then receive 13 choice sets. After completion of the choice tasks, respondents will be asked how difficult they found the choice tasks on a seven-point scale. In the questionnaire the patient chooses between different options for fatigue when doing activities such as walking : Tired not at all, Moderately tired, Tired very easily The attributes and levels are carefully explained in the introduction part of the questionnaire and an example of a completed choice set is provided The level of fatigue is one of the five attributes and different levels of consequences have been identified by the panel. |
1 hour
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Incidence of falls
Ramy czasowe: 1 hour
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The questionnaire is composed by a general explanation of the purpose of the study followed by a definition of sarcopenia and a clear description of the DCE task.
The attributes and levels are carefully explained in the introduction part of the questionnaire and an example of a completed choice set is provided.
Each patient will then receive 13 choice sets.
After completion of the choice tasks, respondents will be asked how difficult they found the choice tasks on a seven-point scale It can be Never, Occasional or Frequent in the questionnaire.
The attributes and levels are carefully explained in the introduction part of the questionnaire and an example of a completed choice set is provided The incidence of falls is one of the five attributes and different levels of consequences have been identified by the panel.
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1 hour
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Rolland Yves, MD, University Hospital, Toulouse
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- RC31/18/0080
- 2018-A00530-55 (Inny identyfikator: ID-RCB)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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