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

October 31, 2019 updated by: Central Hospital, Nancy, France

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

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

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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