Chronic Intestinal FailureSBS-NEEDSNCT04390633
Perception of Needs of Patients With Chronic Intestinal Failure and Their Practitioners: a Qualitative Study
An observational study of Chronic Intestinal Failure and Small Intestine Disease, run by Centre Hospitalier Universitaire de Besancon.
Trial summary
The SBS NEEDS Study is a qualitative transversal study aiming to describe and understand the needs and knowledge of patients with Chronic Intestinal Failure as well as the representations of their practitioners Chronic Intestinal Failure (CIF) is the long-lasting reduction of gut function, below the minimum necessary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Intestinal Failure, Small Intestine Disease
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 31 Dec 2022
- 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: Men and women aged 18 and over, fulfilling the conditions of major Chronic Intestinal Failure (CIF) : "reduction of the intestinal functional mass below the minimum mass sufficient to ensure the absorption of nutrients to maintain nutritional status"
Who may be able to join
- Men and women aged 18 and over
- With Chronic Intestinal Failure (CIF) : "reduction of the intestinal functional mass below the minimum mass sufficient to ensure the absorption of nutrients to maintain nutritional status"
- medical follow-up in one of the two nutrition departments of the study
- Informed consent stating that the subject understood the purpose and methodology of the study and agrees to participate in the study.
Who cannot join
- Persons with proven and significant cognitive impairment preventing the completion of semi-structured interviews
- Person who does not speak French easily
- Generally, any person unlikely to cooperate in the study
- Adults under guardianship
About this study
Official title: Qualitative Assessment of the Needs and Knowledge of Patients With Chronic Intestinal Failure of Their Disease as Well as Those of Their Practitioners
The SBS NEEDS Study is a qualitative transversal study aiming to describe and understand the needs and knowledge of patients with Chronic Intestinal Failure as well as the representations of their practitioners
Chronic Intestinal Failure (CIF) is the long-lasting reduction of gut function, below the minimum necessary for the absorption of macronutrients and/or water and electrolytes, such that intravenous supplementation is required to maintain health and/or growth. CIF is the rarest organ failure. Home parenteral nutrition (HPN) is the primary treatment for CIF.
Read more
Semi-structured interviews will be conducted with patients in two nutrition unit and specialized in the small bowel diseases in two French region. 20 situations will be included.
After analysing the data of the individual interviews, focus groups will be conducted with health professionals from an accredited home parenteral nutrition department.
What is being measured
The primary outcome is the main question the study is designed to answer.
20 semi-structured interviews
Qualitative data analysis - Theorical saturation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start1 Oct 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Intestinal FailureStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Collaborators
- Société Francophone Nutrition Clinique et Métabolisme
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04390633
- Sponsor's protocol ID
- EI/2019/616
- Acronym
- SBS-NEEDS
- Status last verified
- Mar 2020
- First submitted
- 11 May 2020
- Last updated
- 21 Jul 2020
- 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 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative Assessment of the Needs and Knowledge of Patients With Chronic Intestinal Failure of Their Disease as Well as Those of Their Practitioners
- ClinicalTrials.gov ID
- NCT04390633
- Acronym / sponsor ID
- SBS-NEEDS / EI/2019/616
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- Société Francophone Nutrition Clinique et Métabolisme
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 15 May 2020 (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 SBS NEEDS Study is a qualitative transversal study aiming to describe and understand the needs and knowledge of patients with Chronic Intestinal Failure as well as the representations of their practitioners
Chronic Intestinal Failure (CIF) is the long-lasting reduction of gut function, below the minimum necessary for the absorption of macronutrients and/or water and electrolytes, such that intravenous supplementation is required to maintain health and/or growth. CIF is the rarest organ failure. Home parenteral nutrition (HPN) is the primary treatment for CIF.
Semi-structured interviews will be conducted with patients in two nutrition unit and specialized in the small bowel diseases in two French region. 20 situations will be included.
After analysing the data of the individual interviews, focus groups will be conducted with health professionals from an accredited home parenteral nutrition department.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women aged 18 and over, fulfilling the conditions of major Chronic Intestinal Failure (CIF) : "reduction of the intestinal functional mass below the minimum mass sufficient to ensure the absorption of nutrients to maintain nutritional status"
Key inclusion criteria (4 listed)
- Men and women aged 18 and over
- With Chronic Intestinal Failure (CIF) : "reduction of the intestinal functional mass below the minimum mass sufficient to ensure the absorption of nutrients to maintain nutritional status"
- medical follow-up in one of the two nutrition departments of the study
- Informed consent stating that the subject understood the purpose and methodology of the study and agrees to participate in the study.
Key exclusion criteria (4 listed)
- Persons with proven and significant cognitive impairment preventing the completion of semi-structured interviews
- Person who does not speak French easily
- Generally, any person unlikely to cooperate in the study
- Adults under guardianship
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
20 semi-structured interviews
Time frame: 12 months
Qualitative data analysis - Theorical saturation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Intestinal Failure and Small Intestine Disease, run by Centre Hospitalier Universitaire de Besancon.
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 4 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 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
20 semi-structured interviews (time frame: 12 months). 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 21 Jul 2020.