- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04150302
Development and Validation of a Questionnaire to Measure the Impact of SBS and Its Treatments on Patients' Lives (ARTEMIS_GC)
Development and Validation of a Questionnaire to Measure the Impact of Short Bowel Syndrome (SBS) and Its Treatments on Patients' Lives
Today, patients express a very strong need to take into account the consequences of their disease and its treatments in their therapeutic follow-up. It is therefore essential to better understand the needs, expectations and values of patients with SBS in order to better understand the impact of the disease on their lives, and thus improve the conditions for medical, social, psychological and technical care. The clinical expertise of health professionals and meetings with patient associations demonstrate the major gap between the parameters taken into account by physician to evaluate the evolution of the SBS and the day-to-day experience of the disease perceived by the patient.
The objective of the ARTEMIS-GC study is to develop and validate an instrument to measure the impact of SBS and its treatments on daily life from the perspective of patients.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Laetitia Ricci, PhD
- Phone Number: 0033383852092
- Email: l.ricci@chru-nancy.fr
Study Contact Backup
- Name: Francisca Joly, MD, PhD
- Email: francisca.joly@gmail.com
Study Locations
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-
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Paris, France
- Beaujon hospital
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Contact:
- Francisca Joly, MD Pr
- Email: francisca.joly@bjn.aphp.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with SBS defined by a hail length remaining in post-duodenal < 2 meters
- Patients with intestinal insufficiency, i.e. chronic malabsorption requiring energetic and/or hydro-electrolytic intravenous support for more than 6 months
- Patients with a period of at least 6 months after the establishment of the SBS
- Patients who has already had a return home after the establishment of the SBS for a period of at least 3 months
Exclusion Criteria:
- Patients with intestinal insufficiency but with a cause other than SBS
- Lack of understanding of the study
- Not speaking French
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Scale calibration of the new developped questionnaire
Time Frame: about 30 minutes
|
Calibration measure
|
about 30 minutes
|
Structure of the new developped questionnaire
Time Frame: about 30 minutes
|
Structure identification
|
about 30 minutes
|
Convergence proprieties of the new developped questionnaire
Time Frame: about 30 minutes
|
Convergence evaluation
|
about 30 minutes
|
Reproducibility of the new developped questionnaire
Time Frame: Up to 8 days
|
Test of reproducibility
|
Up to 8 days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-A02034-53
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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