SarcopeniaDCE-SarcopeniaNCT03597724
Identification of Critical Outcomes in Sarcopenia
An observational study of Sarcopenia, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Questionnaire composed of 13 choice questions.
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jun 2018to 20 Dec 2018
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Population suffering from diagnosed sarcopenia
Who may be able to join
- Patients with Diagnosis of sarcopenia :
- Muscle mass
- Muscle strength and physical performance should be measured
Who cannot join
- Problem of Cognitive function
- Diagnosis of dementia
- unability to understand the study and the the questionnaire
- unability to fill in the questionnaire
- major depression
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Sarcopenia
- Being tested
- Questionnaire composed of 13 choice questions.
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire composed of 13 choice questions.Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Questionnaire composed of 13 choice questions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour
Secondary outcomes (4)
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.
Measured: 1 hour
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.
Measured: 1 hour
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.
Measured: 1 hour
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.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start20 Jun 2018
- Primary completion20 Dec 2018
- Study completion20 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rolland Yves, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03597724
- Sponsor's protocol ID
- RC31/18/0080
- Other IDs
- 2018-A00530-55
- Acronym
- DCE-Sarcopenia
- Status last verified
- Apr 2019
- First submitted
- 10 Jul 2018
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Critical Outcomes in Sarcopenia: a Discrete Choice Experiment
- ClinicalTrials.gov ID
- NCT03597724
- Acronym / sponsor ID
- DCE-Sarcopenia / RC31/18/0080
- Conditions
- Sarcopenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 24 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient suffering from sarcopenia | – | Other: Questionnaire composed of 13 choice questions.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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Population suffering from diagnosed sarcopenia
Key inclusion criteria (3 listed)
- Patients with Diagnosis of sarcopenia :
- Muscle mass
- Muscle strength and physical performance should be measured
Key exclusion criteria (5 listed)
- Problem of Cognitive function
- Diagnosis of dementia
- unability to understand the study and the the questionnaire
- unability to fill in the questionnaire
- major depression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Patient suffering from sarcopenia |
Primary outcome
Quality of life of the patient who are living with Sarcopenia
Time frame: 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.
4 secondary outcomes
Mobility
Time frame: 1 hour
Capacity of doing domestic activities
Time frame: 1 hour
The level of Fatigue
Time frame: 1 hour
Incidence of falls
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rolland Yves, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life of the patient who are living with Sarcopenia (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019.