NCT04150302

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 4, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

November 4, 2019

Status Verified

September 1, 2019

Enrollment Period

Same day

First QC Date

September 23, 2019

Last Update Submit

October 31, 2019

Conditions

SBS - Short Bowel Syndrome

Outcome Measures

Primary Outcomes (4)

  • 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

Interventions

Exploratory interviewsOTHER

Exploratory interviews to generate an interview guide

Semi-directive interviewsOTHER

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

Delphi ProcessOTHER

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

Think aloud interviewsOTHER

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

Psychometric validationOTHER

Psychometric properties study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beaujon Hospital

Paris, France

Location

MeSH Terms

Conditions

Short Bowel Syndrome

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Laetitia Ricci, PhD

CONTACT

0033383852092l.ricci@chru-nancy.fr

Francisca Joly, MD, PhD

CONTACT

francisca.joly@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2019

First Posted

November 4, 2019

Study Start

January 1, 2020

Primary Completion

January 1, 2020

Study Completion

June 1, 2021

Last Updated

November 4, 2019

Record last verified: 2019-09

Locations

FR(1)