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: Unknown
• Conditions: SBS - Short Bowel Syndrome
• Intervention / Treatment: Other: Exploratory interviews; Other: Semi-directive interviews; Other: Delphi Process; Other: Think aloud interviews; Other: Psychometric validation

• Study Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Beaujon Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients over 18 years with SBS for more than 6 months and returned home for at least 3 months.

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?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Collaborators: Beaujon Hospital; Société Francophone Nutrition Clinique et Métabolisme

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2020
• Primary Completion (ANTICIPATED): January 1, 2020
• Study Completion (ANTICIPATED): June 1, 2021

Study Registration Dates

• First Submitted: September 23, 2019
• First Submitted That Met QC Criteria: October 31, 2019
• First Posted (ACTUAL): November 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 4, 2019
• Last Update Submitted That Met QC Criteria: October 31, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Disease; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Syndrome; Short Bowel Syndrome
• Other Study ID Numbers: 2019-A02034-53

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No