CClinicalTrials.gg
Status unknownNCT04150302ARTEMIS_GCUpdated Nov 4, 2019

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

An observational study in SBS - Short Bowel Syndrome, sponsored by Central Hospital, Nancy, France. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-04.

Sponsored by Central Hospital, Nancy, France · Observational

The sponsor has not verified this record recently (last verified Sep 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
250
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • SBS - Short Bowel Syndrome
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In context

Short Bowel Syndrome

149 studies on the registry are indexed under Short Bowel Syndrome; 25 are open to participants now.

This study's planned enrollment of 250 is above the median of 53 across 36 observational studies indexed under Short Bowel Syndrome.

Browse Short Bowel Syndrome studies →

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

  • Patients with intestinal insufficiency but with a cause other than SBS
  • Lack of understanding of the study
  • Not speaking French
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Study design

Observational model
Other
Time perspective
Other
Enrollment
250 participants (estimated)
Patient registry
No

Interventions

  • OtherExploratory interviews

    Exploratory interviews to generate an interview guide

  • OtherSemi-directive interviews

    Semi-directive interviews to collect qualitative data that will be used for questionnaire item generation

  • OtherDelphi Process

    Cotation of newly developed items pertinence on a 4 points likert scale.

  • OtherThink aloud interviews

    Debriefing session for the newly developed items: final possibility to adjust the tool before validating the psychometric proprieties of the questionnaire.

  • OtherPsychometric validation

    Psychometric properties study

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What researchers measure

Primary outcomes

  1. Scale calibration of the new developped questionnaire

    Calibration measure

    Time frame: about 30 minutes

  2. Structure of the new developped questionnaire

    Structure identification

    Time frame: about 30 minutes

  3. Convergence proprieties of the new developped questionnaire

    Convergence evaluation

    Time frame: about 30 minutes

  4. Reproducibility of the new developped questionnaire

    Test of reproducibility

    Time frame: Up to 8 days

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Study locations

1 site
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04150302
Lead sponsor
Central Hospital, Nancy, France
Collaborators
Beaujon Hospital, Société Francophone Nutrition Clinique et Métabolisme
Responsible party
Sponsor
First posted
Nov 4, 2019
Start date
Jan 2020 (estimated)
Primary completion
Jan 2020 (estimated)
Completion
Jun 2021 (estimated)
Last update
Nov 4, 2019

Study contacts

Laetitia Ricci, PhD
Contact
l.ricci@chru-nancy.fr
0033383852092
Francisca Joly, MD, PhD
Contact
francisca.joly@gmail.com

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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