CClinicalTrials.gg
CompletedNCT03597724DCE-SarcopeniaUpdated Apr 18, 2019

Identification of Critical Outcomes in Sarcopenia

An observational study in Sarcopenia, sponsored by University Hospital, Toulouse. Completed at 1 site in France. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2019-04-18.

Sponsored by University Hospital, Toulouse · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
40
Ages
65 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Sarcopenia

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03

In context

Sarcopenia

1,206 studies on the registry are indexed under Sarcopenia; 401 are open to participants now.

This study's enrollment of 40 is below the median of 120 across 419 observational studies indexed under Sarcopenia.

Browse Sarcopenia studies →

Lead sponsor

University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Population suffering from diagnosed sarcopenia

Inclusion criteria

  • Patients with Diagnosis of sarcopenia :
  • Muscle mass
  • Muscle strength and physical performance should be measured

Exclusion criteria

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
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
40 participants (actual)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • 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.

    Other: Questionnaire composed of 13 choice questions.

Interventions

  • OtherQuestionnaire 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.

06

What researchers measure

Primary outcomes

  1. Quality of life of the patient who are living with Sarcopenia

    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.

    Time frame: 1 hour

Secondary outcomes

  1. Mobility

    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.

    Time frame: 1 hour

  2. Capacity of doing domestic activities

    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.

    Time frame: 1 hour

  3. The level of Fatigue

    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.

    Time frame: 1 hour

  4. Incidence of falls

    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.

    Time frame: 1 hour

07

Study locations

1 site
  • University Hospital Toulouse
    Toulouse, 31059, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03597724
Lead sponsor
University Hospital, Toulouse
Responsible party
Sponsor
First posted
Jul 24, 2018
Start date
Jun 20, 2018
Primary completion
Dec 20, 2018
Completion
Dec 20, 2018
Last update
Apr 18, 2019

Study contacts

Rolland Yves, MD
principal investigator · University Hospital, Toulouse

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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