Perception of Needs of Patients With Chronic Intestinal Failure and Their Practitioners: a Qualitative Study

Small Intestine Disease Clinical Trial

— SBS-NEEDS  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04390633
• Other study ID #: EI/2019/616
• Status: Not yet recruiting
• Start date: October 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2020
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Chronic Intestinal Failure
• Intestinal Diseases
• Small Intestine Disease

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon	Société Francophone Nutrition Clinique et Métabolisme

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	20 semi-structured interviews	Qualitative data analysis - Theorical saturation	12 months