SBS - Short Bowel SyndromeARTEMIS_GCNCT04150302
Development and Validation of a Questionnaire to Measure the Impact of SBS and Its Treatments on Patients' Lives
An observational study of SBS - Short Bowel Syndrome, run by Central Hospital, Nancy, France at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SBS - Short Bowel Syndrome
- What is being tested?
- Exploratory interviews, Semi-directive interviews and Delphi Process
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2020to Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over 18 years with SBS for more than 6 months and returned home for at least 3 months.
Who may be able to join
- 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
Who cannot join
- Patients with intestinal insufficiency but with a cause other than SBS
- Lack of understanding of the study
- Not speaking French
Trial locations and contacts
1 site in 1 country.
Francisca Joly, MD, PhD contact
France1 site
Beaujon Hospital
Paris
Francisca Joly, MD Pr, francisca.joly@bjn.aphp.fr
About this study
Official title: 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.
- Conditions
- SBS - Short Bowel Syndrome
- Being tested
- Exploratory interviews, Semi-directive interviews, Delphi Process, Think aloud interviews, Psychometric validation
- Medical subject headings
- Short Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Scale calibration of the new developped questionnaire
Calibration measure
Measured: about 30 minutes
Structure of the new developped questionnaire
Structure identification
Measured: about 30 minutes
Convergence proprieties of the new developped questionnaire
Convergence evaluation
Measured: about 30 minutes
Reproducibility of the new developped questionnaire
Test of reproducibility
Measured: Up to 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study startJan 2020 (estimated)
- Primary completionJan 2020 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SBS - Short Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- Beaujon Hospital, Société Francophone Nutrition Clinique et Métabolisme
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04150302
- Sponsor's protocol ID
- 2019-A02034-53
- Acronym
- ARTEMIS_GC
- Status last verified
- Sep 2019
- First submitted
- 23 Sep 2019
- Last updated
- 4 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Questionnaire to Measure the Impact of Short Bowel Syndrome (SBS) and Its Treatments on Patients' Lives
- ClinicalTrials.gov ID
- NCT04150302
- Acronym / sponsor ID
- ARTEMIS_GC / 2019-A02034-53
- Conditions
- SBS - Short Bowel Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- Beaujon Hospital, Société Francophone Nutrition Clinique et Métabolisme
- Study start
- Jan 2020 (estimated)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 4 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years with SBS for more than 6 months and returned home for at least 3 months.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Patients with intestinal insufficiency but with a cause other than SBS
- Lack of understanding of the study
- Not speaking French
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exploratory interviewsExploratory interviews to generate an interview guide | Other | – |
| Semi-directive interviewsSemi-directive interviews to collect qualitative data that will be used for questionnaire item generation | Other | – |
| Delphi ProcessCotation of newly developed items pertinence on a 4 points likert scale. | Other | – |
| Think aloud interviewsDebriefing session for the newly developed items: final possibility to adjust the tool before validating the psychometric proprieties of the questionnaire. | Other | – |
| Psychometric validationPsychometric properties study | Other | – |
Primary outcome
Scale calibration of the new developped questionnaire
Time frame: about 30 minutes
Calibration measure
Structure of the new developped questionnaire
Time frame: about 30 minutes
Structure identification
Convergence proprieties of the new developped questionnaire
Time frame: about 30 minutes
Convergence evaluation
Reproducibility of the new developped questionnaire
Time frame: Up to 8 days
Test of reproducibility
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisca Joly, MD, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SBS - Short Bowel Syndrome, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laetitia Ricci, PhD (0033383852092, l.ricci@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scale calibration of the new developped questionnaire (time frame: about 30 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2019.