Inflammatory Bowel DiseasesSOFANCT06186999
Social and Demographic Determinants of Fatigue in Patients With Inflammatory Bowel Disease in Remission
An observational study of Inflammatory Bowel Diseases and Remission, run by University Hospital, Grenoble at 4 sites in France.
Trial summary
The aim of this observational study is to identify the social and demographic determinants of fatigue in patients with inflammatory bowel disease in remission. Secondly, the objectives of the study are to: Assess the impact of fatigue on the quality of life of patients with inflammatory bowel disease in remission. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Remission, Fatigue
- How many people
- 208 participants
- Where
- 4 sitesFrance
- Study dates
- 17 Jan 2024to 24 Jun 2024
- 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: The study concerns patients with chronic inflammatory bowel disease in remission, such as Crohn's disease or ulcerative colitis.
Who may be able to join
- Patient in clinical remission for at least 6 months:
- for Crohn's disease patients: Harvey Bradshaw Index (HBI) score ≤ 4
- for patients with ulcerative colitis: a partial Mayo score (PMS) ≤ 2 with each subscore of 1 or less)
- Patient in biological remission for at least 6 months fecal calprotectin <250 μg/g and CRP <5 mg/
- Documented diagnosis of Crohn's disease or ulcerative colitis based on standard clinical, endoscopic and histological criteria
- FACIT-F score < 40 (defining significant fatigue)
- Subjects at least 18 years of age at the time of study inclusion
Who cannot join
- Severe acute colitis
- Active infection with HIV, hepatitis B, hepatitis C, or untreated tuberculosis
- Patient(s) objecting to the use of their data for research purposes
Trial locations and contacts
4 sites in 1 country.
France4 sites
CHU Bordeaux Hôpital Haut Lévêque
Bordeaux
CHUGA
Grenoble
Chu Lyon Sud _ Hcl
Lyon
Chu Montpellier
Montpellier
About this study
The aim of this observational study is to identify the social and demographic determinants of fatigue in patients with inflammatory bowel disease in remission.
Secondly, the objectives of the study are to:
Read more
- Assess the impact of fatigue on the quality of life of patients with inflammatory bowel disease in remission.
- To determine the profile of patients with inflammatory bowel disease in remission who are fatigued.
To this end, during a consultation or hospitalization, participants will be asked to respond independently to various questionnaires (FACIT-F, DIPCare, SSQ6, questionnaire on socio-demographic determinants and IBD disk). Characteristics of the type of chronic inflammatory bowel disease will be collected from medical records.
There will be no patient follow-up as part of the study. Participants may be contacted by telephone by the center's investigator within 2 weeks of the interview in the event of a partial or imprecise response.
- Conditions
- Inflammatory Bowel Diseases, Remission, Fatigue
- Medical subject headings
- Inflammatory Bowel Diseases, Fatigue
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the relationship : fatigue - social precariousness
Description of the relationship between social precariousness assessed by the "DiPCare" questionnaire and fatigue assessed by the FACIT-F questionnaire in patients with inflammatory bowel disease in remission.
Measured: at enrollment
Description of the relationship : patient social support - fatigue.
Description of the relationship between patient social support (availability and satisfaction of the patient's entourage) assessed by the "SARASON" (or "SSQ6") questionnaire and fatigue assessed by the FACIT-F questionnaire in patients with inflammatory bowel disease in remission.
Measured: at enrollment
Description of the relationship : demographic determinants - fatigue.
Description of the relationship between demographic determinants assessed by the questionnaire, and fatigue assessed by the FACIT-F questionnaire in patients with inflammatory bowel disease in remission.
Measured: at enrollment
Secondary outcomes (1)
Assessing quality of life in IBD patients
Functional visual handicap score based on IBD-Disk visual aid, evaluated at enrollment.
Measured: at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start17 Jan 2024
- Primary completion24 Jun 2024
- Study completion24 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Mathieu, Pr, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06186999
- Sponsor's protocol ID
- 2023-A01692-43
- Acronym
- SOFA
- Status last verified
- Apr 2025
- First submitted
- 13 Oct 2023
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social and Demographic Determinants of Fatigue in Patients With Inflammatory Bowel Disease in Remission
- ClinicalTrials.gov ID
- NCT06186999
- Acronym / sponsor ID
- SOFA / 2023-A01692-43
- Conditions
- Inflammatory Bowel Diseases, Remission, Fatigue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 17 Jan 2024 (actual)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 2 Jan 2024 (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.
The aim of this observational study is to identify the social and demographic determinants of fatigue in patients with inflammatory bowel disease in remission.
Secondly, the objectives of the study are to:
- Assess the impact of fatigue on the quality of life of patients with inflammatory bowel disease in remission.
- To determine the profile of patients with inflammatory bowel disease in remission who are fatigued.
To this end, during a consultation or hospitalization, participants will be asked to respond independently to various questionnaires (FACIT-F, DIPCare, SSQ6, questionnaire on socio-demographic determinants and IBD disk). Characteristics of the type of chronic inflammatory bowel disease will be collected from medical records.
There will be no patient follow-up as part of the study. Participants may be contacted by telephone by the center's investigator within 2 weeks of the interview in the event of a partial or imprecise response.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study concerns patients with chronic inflammatory bowel disease in remission, such as Crohn's disease or ulcerative colitis.
Key inclusion criteria (7 listed)
- Patient in clinical remission for at least 6 months:
- Patient in biological remission for at least 6 months fecal calprotectin <250 μg/g and CRP <5 mg/
- Documented diagnosis of Crohn's disease or ulcerative colitis based on standard clinical, endoscopic and histological criteria
- FACIT-F score < 40 (defining significant fatigue)
- Subjects at least 18 years of age at the time of study inclusion
Key exclusion criteria (3 listed)
- Severe acute colitis
- Active infection with HIV, hepatitis B, hepatitis C, or untreated tuberculosis
- Patient(s) objecting to the use of their data for research purposes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Description of the relationship : fatigue - social precariousness
Time frame: at enrollment
Description of the relationship between social precariousness assessed by the "DiPCare" questionnaire and fatigue assessed by the FACIT-F questionnaire in patients with inflammatory bowel disease in remission.
Description of the relationship : patient social support - fatigue.
Time frame: at enrollment
Description of the relationship between patient social support (availability and satisfaction of the patient's entourage) assessed by the "SARASON" (or "SSQ6") questionnaire and fatigue assessed by the FACIT-F questionnaire in patients with inflammatory bowel disease in remission.
Description of the relationship : demographic determinants - fatigue.
Time frame: at enrollment
Description of the relationship between demographic determinants assessed by the questionnaire, and fatigue assessed by the FACIT-F questionnaire in patients with inflammatory bowel disease in remission.
1 secondary outcome
Assessing quality of life in IBD patients
Time frame: at enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
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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.
Nicolas Mathieu, Pr principal investigator
University Hospital, Grenoble
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases and Remission, run by University Hospital, Grenoble at 4 sites 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 7 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: finished, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of the relationship : fatigue - social precariousness (time frame: at enrollment). The study lists 3 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 18 Apr 2025.