Clinical trial NCT03597724: Identification of Critical Outcomes in Sarcopenia
Official title: Identification of Critical Outcomes in Sarcopenia: a Discrete Choice Experiment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcopenia
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2018-07-24
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population suffering from diagnosed sarcopenia

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of life of the patient who are living with Sarcopenia
timeFrame: 1 hour
Secondary outcomes:
measure: Mobility
timeFrame: 1 hour
measure: Capacity of doing domestic activities
timeFrame: 1 hour
measure: The level of Fatigue
timeFrame: 1 hour
measure: Incidence of falls
timeFrame: 1 hour
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Rolland Yves, MD
role: PRINCIPAL_INVESTIGATOR
References: