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Identification of Critical Outcomes in Sarcopenia (DCE-Sarcopenia)

16 aprile 2019 aggiornato da: University Hospital, Toulouse

Identification of Critical Outcomes in Sarcopenia: a Discrete Choice Experiment

Patients will be recruited on each site according to inclusion criteria. Participants willing to participate will received an information sheet and a consent form. After given their consent to participate, they will receive a questionnaire composed of 13 choice questions. In this 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.

Panoramica dello studio

Stato

Completato

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

40

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Toulouse, Francia, 31059
        • University Hospital Toulouse

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

65 anni e precedenti (Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Population suffering from diagnosed sarcopenia

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Quality of life of the patient who are living with Sarcopenia
Lasso di tempo: 1 hour
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.
1 hour

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mobility
Lasso di tempo: 1 hour
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.
1 hour
Capacity of doing domestic activities
Lasso di tempo: 1 hour
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.
1 hour
The level of Fatigue
Lasso di tempo: 1 hour

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
Incidence of falls
Lasso di tempo: 1 hour
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.
1 hour

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Rolland Yves, MD, University Hospital, Toulouse

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

20 giugno 2018

Completamento primario (Effettivo)

20 dicembre 2018

Completamento dello studio (Effettivo)

20 dicembre 2018

Date di iscrizione allo studio

Primo inviato

10 luglio 2018

Primo inviato che soddisfa i criteri di controllo qualità

20 luglio 2018

Primo Inserito (Effettivo)

24 luglio 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 aprile 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 aprile 2019

Ultimo verificato

1 aprile 2019

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • RC31/18/0080
  • 2018-A00530-55 (Altro identificatore: ID-RCB)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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