Development and Validation of a Questionnaire to Measure the Impact of SBS and Its Treatments on Patients' Lives

• Conditions: SBS - Short Bowel Syndrome

• Registration Number: NCT04150302
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-09
• Study First Submitted: 2019-09-23
• Study First Submitted QC: 2019-10-31
• Last Update Submitted: 2019-10-31
• Study First Posted: 2019-11-04
• Last Update Posted: 2019-11-04
• Study Start: 2020-01
• Primary Completion: 2020-01
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Scale calibration of the new developped questionnaire	about 30 minutes	Calibration measure
Structure of the new developped questionnaire	about 30 minutes	Structure identification
Convergence proprieties of the new developped questionnaire	about 30 minutes	Convergence evaluation
Reproducibility of the new developped questionnaire	Up to 8 days	Test of reproducibility

Trial Locations

Locations (1)

Beaujon Hospital; 🇫🇷 Paris, France