Identification of Critical Outcomes in Sarcopenia

NCT03597724 | Completed

• 2 other identifiers: RC31/18/00802018-A00530-55
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia

Outcome Measures

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.

  1 hour

Secondary Outcomes (4)

• Mobility

  1 hour

• Capacity of doing domestic activities

  1 hour

• The level of Fatigue

  1 hour

• Incidence of falls

  1 hour

Study Arms (1)

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

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.

Patient suffering from sarcopenia

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Population suffering from diagnosed sarcopenia

You may qualify if:

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

You may not qualify if:

• Problem of Cognitive function
• Diagnosis of dementia
• unability to understand the study and the the questionnaire
• unability to fill in the questionnaire
• major depression

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Rolland Yves, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: July 24, 2018
• Study Start: June 20, 2018
• Primary Completion: December 20, 2018
• Study Completion: December 20, 2018
• Last Updated: April 18, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)