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

SBS - Short Bowel Syndrome Clinical Trial

— ARTEMIS_GC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04150302
• Other study ID #: 2019-A02034-53
• Status: Not yet recruiting
• Start date: January 2020
• Est. completion date: June 2021

Study information

• Verified date: September 2019
• Source: Central Hospital, Nancy, France
• Contact: Laetitia Ricci, PhD
• Phone: 0033383852092
• Email: l.ricci[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: June 2021
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• SBS - Short Bowel Syndrome
• Short Bowel Syndrome
• Syndrome

Intervention

Other:
• Exploratory interviews
Exploratory interviews to generate an interview guide
• Semi-directive interviews
Semi-directive interviews to collect qualitative data that will be used for questionnaire item generation
• Delphi Process
Cotation of newly developed items pertinence on a 4 points likert scale.
• Think aloud interviews
Debriefing session for the newly developed items: final possibility to adjust the tool before validating the psychometric proprieties of the questionnaire.
• Psychometric validation
Psychometric properties study

Locations

Country	Name	City	State
France	Beaujon Hospital	Paris

Sponsors (3)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France	Beaujon Hospital, Société Francophone Nutrition Clinique et Métabolisme

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scale calibration of the new developped questionnaire	Calibration measure	about 30 minutes
Primary	Structure of the new developped questionnaire	Structure identification	about 30 minutes
Primary	Convergence proprieties of the new developped questionnaire	Convergence evaluation	about 30 minutes
Primary	Reproducibility of the new developped questionnaire	Test of reproducibility	Up to 8 days